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A Retrospective Study to Assess the Impact of the Use of Interferon in Patients With Chronic Hepatitis C (DECISION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01280656
Recruitment Status : Completed
First Posted : January 21, 2011
Results First Posted : September 26, 2016
Last Update Posted : November 29, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Hepatitis C, Chronic
Interventions Drug: Conventional Interferon
Drug: Peginterferon Alfa-2a
Drug: Peginterferon Alfa-2b
Drug: Ribavirin
Enrollment 660
Recruitment Details A total of 660 participants were enrolled from 39 centers in Brazil. The study was conducted from January 2010 to June 2013.
Pre-assignment Details  
Arm/Group Title Conventional Interferon Plus Ribavirin Peginterferon Alfa-2a Plus Ribavirin Peginterferon Alfa-2b Plus Ribavirin
Hide Arm/Group Description Eligible participants who received conventional interferon plus ribavirin for Chronic Hepatitis C (CHC) according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks). Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks). Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Period Title: Overall Study
Started 62 312 286
Completed 59 265 223
Not Completed 3 47 63
Reason Not Completed
Adverse Event             1             14             13
Lack of Efficacy             1             22             38
Treatment shortening (RGT)             0             4             5
Other             1             7             7
Arm/Group Title Conventional Interferon Plus Ribavirin Peginterferon Alfa-2a Plus Ribavirin Peginterferon Alfa-2b Plus Ribavirin Total
Hide Arm/Group Description Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks). Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks). Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks). Total of all reporting groups
Overall Number of Baseline Participants 62 312 286 660
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants 312 participants 286 participants 660 participants
50.4  (8.6) 49.2  (10.7) 49.5  (9.5) 49.5  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 312 participants 286 participants 660 participants
Female
22
  35.5%
188
  60.3%
147
  51.4%
357
  54.1%
Male
40
  64.5%
124
  39.7%
139
  48.6%
303
  45.9%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response at 12 Weeks After End of Treatment
Hide Description Sustained virological response (SVR) was defined as virological response at 12 weeks after end of treatment (EOT). Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid [HCV RNA] was detected in the participants' plasma samples) or less than 50 international units/milliliter (IU/mL) HCV RNA (that is, the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). EOT= Week 48. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.
Time Frame At Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group (16, 126, and 101 respectively).
Arm/Group Title Conventional Interferon Plus Ribavirin Peginterferon Alfa-2a Plus Ribavirin Peginterferon Alfa-2b Plus Ribavirin
Hide Arm/Group Description:
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Overall Number of Participants Analyzed 16 126 101
Measure Type: Number
Unit of Measure: percentage of participants
0 7.1 20.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peginterferon Alfa-2a Plus Ribavirin, Peginterferon Alfa-2b Plus Ribavirin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response at 24 Weeks After End of Treatment
Hide Description SVR was defined as virological response at 24 weeks after EOT, EOT= Week 48. Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid [HCV RNA] was detected in the participants' plasma samples) or less than 50 IU/mL HCV RNA (that is, the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.
Time Frame At Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group (16, 126, and 101 respectively).
Arm/Group Title Conventional Interferon Plus Ribavirin Peginterferon Alfa-2a Plus Ribavirin Peginterferon Alfa-2b Plus Ribavirin
Hide Arm/Group Description:
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Overall Number of Participants Analyzed 16 126 101
Measure Type: Number
Unit of Measure: percentage of participants
62.5 74.6 72.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peginterferon Alfa-2a Plus Ribavirin, Peginterferon Alfa-2b Plus Ribavirin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.693
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Interferon Dose Reduction Rates in Function of the Interferon Type Being Used
Hide Description The number of participants with Interferon dose reduction rates in function of the interferon type being used are reported
Time Frame At Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in the participants who were available for interferon dose reduction rates in each group (56, 302, and 280 respectively).
Arm/Group Title Conventional Interferon Plus Ribavirin Peginterferon Alfa-2a Plus Ribavirin Peginterferon Alfa-2b Plus Ribavirin
Hide Arm/Group Description:
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Overall Number of Participants Analyzed 56 302 280
Measure Type: Number
Unit of Measure: participants
1 9 29
4.Secondary Outcome
Title Percentage of Participants With Early Virologic Response at Week 12
Hide Description An early virologic response (EVR) was defined as a HCV-RNA decrease of at least two logarithmic scales (2 Log) or 100 times the pretreatment value or non-detection at Week 12 of treatment period.
Time Frame At Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.
Arm/Group Title Conventional Interferon Plus Ribavirin Peginterferon Alfa-2a Plus Ribavirin Peginterferon Alfa-2b Plus Ribavirin
Hide Arm/Group Description:
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Overall Number of Participants Analyzed 62 312 286
Measure Type: Number
Unit of Measure: percentage of participants
14.5 37.2 35.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peginterferon Alfa-2a Plus Ribavirin, Peginterferon Alfa-2b Plus Ribavirin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.573
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response Treated at Interferon Application Centers and Treated at Home
Hide Description The percentage of participants with SVR-12 and SVR-24 treated at interferon application centers (IAC) and treated at home are presented.
Time Frame At Week 60 (SVR 12) and Week 72 (SVR 24)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group excluding participants treated at an unknown location (2/16, 5/126, and 9/101 respectively).
Arm/Group Title Conventional Interferon Plus Ribavirin Peginterferon Alfa-2a Plus Ribavirin Peginterferon Alfa-2b Plus Ribavirin
Hide Arm/Group Description:
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Overall Number of Participants Analyzed 14 121 92
Measure Type: Number
Unit of Measure: percentage of participants
SVR-12, treated at IAC (n=0, 40, 35) NA [1]  5.0 2.9
SVR-12, treated at home (n=14, 81, 57) 0 8.6 33.3
SVR-24, treated at IAC (n=0, 40, 35) NA [1]  80.0 77.1
SVR-24, treated at home (n=14, 81, 57) 64.3 75.3 68.4
[1]
No participants were available for analysis in this arm.
6.Secondary Outcome
Title Percentage of Participants Who Were Treated at Interferon Application Centers and at Home and Discontinued Treatment
Hide Description The percentage of participants who were treated at interferon application centers and at home and who discontinued treatment is presented. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis excluded participants treated at an unknown location (7/62, 10/312, and 23/286 respectively)
Arm/Group Title Conventional Interferon Plus Ribavirin Peginterferon Alfa-2a Plus Ribavirin Peginterferon Alfa-2b Plus Ribavirin
Hide Arm/Group Description:
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Overall Number of Participants Analyzed 55 302 263
Measure Type: Number
Unit of Measure: percentage of participants
At the site (n=0,98,126) NA [1]  17.4 17.5
At home (n=55,204,137) 5.5 11.8 21.9
[1]
No participants were available for analysis in this arm.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peginterferon Alfa-2a Plus Ribavirin, Peginterferon Alfa-2b Plus Ribavirin
Comments Mean at the site
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.982
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Peginterferon Alfa-2a Plus Ribavirin, Peginterferon Alfa-2b Plus Ribavirin
Comments Mean at home
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
7.Secondary Outcome
Title Mean Percentage Reduction of Hemoglobin in Treatment Responders and Treatment Non-Responders
Hide Description The average percentage reduction of hemoglobin (Hb) in treatment responders and treatment non-responders between the conventional group, peginterferon alfa-2a plus and peginterferon alfa-2b is presented. Participants with undetectable HCV RNA at specified time points (Weeks 4/12/18/24/48) were considered as treatment responders. Participants with positive viral load (detectable HCV RNA) at end of treatment regardless of the treatment duration were considered as treatment non-responders.
Time Frame Up to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. Treatment responders and non-responders for whom data was available were considered for this outcome measure.
Arm/Group Title Conventional Interferon Plus Ribavirin Peginterferon Alfa-2a Plus Ribavirin Peginterferon Alfa-2b Plus Ribavirin
Hide Arm/Group Description:
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Overall Number of Participants Analyzed 10 73 63
Mean (Standard Deviation)
Unit of Measure: mean percentage reduction of hemoglobin
Responders (n=0,19,15) NA [1]   (NA) 14.4  (8.5) 15.8  (10.3)
Non-responders (n=10,54,48) 18.3  (9.5) 9.8  (27.7) 12.6  (11.1)
[1]
No participants were available for analysis in this arm.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peginterferon Alfa-2a Plus Ribavirin
Comments Responders vs Non-responders
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.476
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Peginterferon Alfa-2b Plus Ribavirin
Comments Responders vs Non-Responders
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.320
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With Rapid Virologic Response at Week 4
Hide Description Rapid virologic response was defined as qualitative or quantitative HCV-RNA (viral load) undetectable (below the lower limit of detection) at Week 4 of treatment period.
Time Frame At Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.
Arm/Group Title Conventional Interferon Plus Ribavirin Peginterferon Alfa-2a Plus Ribavirin Peginterferon Alfa-2b Plus Ribavirin
Hide Arm/Group Description:
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Overall Number of Participants Analyzed 62 312 286
Measure Type: Number
Unit of Measure: percentage of participants
6.5 21.2 20.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peginterferon Alfa-2a Plus Ribavirin, Peginterferon Alfa-2b Plus Ribavirin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.792
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants With Virologic Response at End of Treatment
Hide Description Virologic response at EOT was defined as undetectable HCV-RNA at EOT (regardless in which week treatment was concluded). EOT = Week 48.
Time Frame At Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.
Arm/Group Title Conventional Interferon Plus Ribavirin Peginterferon Alfa-2a Plus Ribavirin Peginterferon Alfa-2b Plus Ribavirin
Hide Arm/Group Description:
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Overall Number of Participants Analyzed 62 312 286
Measure Type: Number
Unit of Measure: percentage of participants
25.8 40.4 35.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peginterferon Alfa-2a Plus Ribavirin, Peginterferon Alfa-2b Plus Ribavirin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.202
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants With Virologic Relapse up to Week 72
Hide Description Virologic relapse was defined as undetectable HCV-RNA at end of treatment and detectable HCV-RNA at the last follow-up assessment available. If the participant was a responder at end of treatment and was not submitted to any viral load assessment during the follow-up period, he was considered a relapser.
Time Frame Up to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group (16, 126, and 101 respectively).
Arm/Group Title Conventional Interferon Plus Ribavirin Peginterferon Alfa-2a Plus Ribavirin Peginterferon Alfa-2b Plus Ribavirin
Hide Arm/Group Description:
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Overall Number of Participants Analyzed 16 126 101
Measure Type: Number
Unit of Measure: percentage of participants
37.5 22.2 22.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peginterferon Alfa-2a Plus Ribavirin, Peginterferon Alfa-2b Plus Ribavirin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.921
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants With Null Response or No Responder at End of Treatment
Hide Description Null response or no responders were defined as those participants presenting positive viral load at EOT (regardless of the treatment duration). EOT= Week 48.
Time Frame At Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.
Arm/Group Title Conventional Interferon Plus Ribavirin Peginterferon Alfa-2a Plus Ribavirin Peginterferon Alfa-2b Plus Ribavirin
Hide Arm/Group Description:
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Overall Number of Participants Analyzed 62 312 286
Measure Type: Number
Unit of Measure: percentage of participants
74.2 59.6 64.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peginterferon Alfa-2a Plus Ribavirin, Peginterferon Alfa-2b Plus Ribavirin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.202
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Participants Who Discontinued Treatment Due to Adverse Events
Hide Description The percentage of participants with treatment discontinuation rates due to adverse events (AE) between conventional group, peginterferon alfa-2a and peginterferon alfa-2b is presented.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.
Arm/Group Title Conventional Interferon Plus Ribavirin Peginterferon Alfa-2a Plus Ribavirin Peginterferon Alfa-2b Plus Ribavirin
Hide Arm/Group Description:
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Overall Number of Participants Analyzed 62 312 286
Measure Type: Number
Unit of Measure: percentage of participants
1.6 4.5 4.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peginterferon Alfa-2a Plus Ribavirin, Peginterferon Alfa-2b Plus Ribavirin
Comments Total
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.973
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
13.Secondary Outcome
Title Number of Participants With Any Adverse Events and Any Serious Adverse Events
Hide Description An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes.
Time Frame Up to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.
Arm/Group Title Conventional Interferon Plus Ribavirin Peginterferon Alfa-2a Plus Ribavirin Peginterferon Alfa-2b Plus Ribavirin
Hide Arm/Group Description:
Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Overall Number of Participants Analyzed 62 312 286
Measure Type: Number
Unit of Measure: participants
any AE 57 285 264
any SAE 2 15 9
Time Frame Up to Week 72
Adverse Event Reporting Description Serious adverse events and non-serious adverse events are reported in ITT population set.
 
Arm/Group Title Conventional Interferon Plus Ribavirin Peginterferon Alfa-2a Plus Ribavirin Peginterferon Alfa-2b Plus Ribavirin
Hide Arm/Group Description Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy. Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy.
All-Cause Mortality
Conventional Interferon Plus Ribavirin Peginterferon Alfa-2a Plus Ribavirin Peginterferon Alfa-2b Plus Ribavirin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Conventional Interferon Plus Ribavirin Peginterferon Alfa-2a Plus Ribavirin Peginterferon Alfa-2b Plus Ribavirin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/62 (3.23%)   15/312 (4.81%)   9/286 (3.15%) 
Blood and lymphatic system disorders       
Anaemia  1  0/62 (0.00%)  1/312 (0.32%)  3/286 (1.05%) 
Bone marrow failure  1  0/62 (0.00%)  1/312 (0.32%)  0/286 (0.00%) 
Neutropaenia  1  0/62 (0.00%)  0/312 (0.00%)  1/286 (0.35%) 
Febrile neutropaenia  1  0/62 (0.00%)  0/312 (0.00%)  1/286 (0.35%) 
Thrombocytopaenia  1  0/62 (0.00%)  0/312 (0.00%)  1/286 (0.35%) 
Cardiac disorders       
Thoracic pain  1  0/62 (0.00%)  0/312 (0.00%)  1/286 (0.35%) 
Atrial fibrillation  1  0/62 (0.00%)  1/312 (0.32%)  0/286 (0.00%) 
Gastrointestinal disorders       
Appendicitis  1  0/62 (0.00%)  1/312 (0.32%)  0/286 (0.00%) 
Abdominal pain  1  0/62 (0.00%)  1/312 (0.32%)  0/286 (0.00%) 
Inguinal hernia  1  1/62 (1.61%)  0/312 (0.00%)  0/286 (0.00%) 
Hepatobiliary disorders       
Gallstones  1  0/62 (0.00%)  0/312 (0.00%)  1/286 (0.35%) 
Immune system disorders       
Cryoglobulinaemia  1  0/62 (0.00%)  1/312 (0.32%)  0/286 (0.00%) 
Infections and infestations       
Urinary tract infection  1  0/62 (0.00%)  1/312 (0.32%)  1/286 (0.35%) 
Cell tissue inflammation  1  0/62 (0.00%)  1/312 (0.32%)  0/286 (0.00%) 
Osteomyelitis  1  0/62 (0.00%)  1/312 (0.32%)  0/286 (0.00%) 
Injury, poisoning and procedural complications       
Multiple injuries  1  0/62 (0.00%)  1/312 (0.32%)  0/286 (0.00%) 
Metabolism and nutrition disorders       
Diabetic Ketoacidosis  1  0/62 (0.00%)  0/312 (0.00%)  1/286 (0.35%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Hepatocellular carcinoma  1  0/62 (0.00%)  1/312 (0.32%)  0/286 (0.00%) 
Vocal cord neoplasia  1  0/62 (0.00%)  1/312 (0.32%)  0/286 (0.00%) 
Breast tumour  1  0/62 (0.00%)  1/312 (0.32%)  0/286 (0.00%) 
Psychiatric disorders       
Depression  1  1/62 (1.61%)  0/312 (0.00%)  0/286 (0.00%) 
Reproductive system and breast disorders       
Breast mass  1  0/62 (0.00%)  1/312 (0.32%)  0/286 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  0/62 (0.00%)  1/312 (0.32%)  0/286 (0.00%) 
Pneumonia  1  0/62 (0.00%)  0/312 (0.00%)  1/286 (0.35%) 
Vascular disorders       
Thrombophlebitis  1  0/62 (0.00%)  1/312 (0.32%)  0/286 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Conventional Interferon Plus Ribavirin Peginterferon Alfa-2a Plus Ribavirin Peginterferon Alfa-2b Plus Ribavirin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   55/62 (88.71%)   275/312 (88.14%)   262/286 (91.61%) 
Blood and lymphatic system disorders       
Anaemia  1  11/62 (17.74%)  109/312 (34.94%)  111/286 (38.81%) 
Leucopaenia  1  1/62 (1.61%)  14/312 (4.49%)  20/286 (6.99%) 
Neutropaenia  1  3/62 (4.84%)  60/312 (19.23%)  45/286 (15.73%) 
Thrombocytopaenia  1  3/62 (4.84%)  27/312 (8.65%)  21/286 (7.34%) 
Gastrointestinal disorders       
Diarrhoea  1  3/62 (4.84%)  21/312 (6.73%)  27/286 (9.44%) 
Abdominal pain  1  1/62 (1.61%)  10/312 (3.21%)  16/286 (5.59%) 
High abdominal pain  1  7/62 (11.29%)  25/312 (8.01%)  23/286 (8.04%) 
Nausea  1  10/62 (16.13%)  57/312 (18.27%)  45/286 (15.73%) 
Vomiting  1  7/62 (11.29%)  21/312 (6.73%)  20/286 (6.99%) 
General disorders       
Asthenia  1  23/62 (37.10%)  114/312 (36.54%)  107/286 (37.41%) 
Pain  1  3/62 (4.84%)  19/312 (6.09%)  30/286 (10.49%) 
Flu condition  1  3/62 (4.84%)  25/312 (8.01%)  50/286 (17.48%) 
Fatigue  1  9/62 (14.52%)  36/312 (11.54%)  35/286 (12.24%) 
Malaise  1  7/62 (11.29%)  19/312 (6.09%)  21/286 (7.34%) 
Pyrexia  1  16/62 (25.81%)  65/312 (20.83%)  66/286 (23.08%) 
Metabolism and nutrition disorders       
Decreased appetite  1  12/62 (19.35%)  75/312 (24.04%)  52/286 (18.18%) 
Cachexia  1  2/62 (3.23%)  9/312 (2.88%)  17/286 (5.94%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  6/62 (9.68%)  16/312 (5.13%)  16/286 (5.59%) 
Pain in extremities  1  1/62 (1.61%)  15/312 (4.81%)  16/286 (5.59%) 
Dorsalgia  1  1/62 (1.61%)  9/312 (2.88%)  19/286 (6.64%) 
Myalgia  1  8/62 (12.90%)  51/312 (16.35%)  33/286 (11.54%) 
Nervous system disorders       
Headache  1  19/62 (30.65%)  67/312 (21.47%)  67/286 (23.43%) 
Insomnia  1  6/62 (9.68%)  43/312 (13.78%)  30/286 (10.49%) 
Dizziness  1  5/62 (8.06%)  28/312 (8.97%)  25/286 (8.74%) 
Psychiatric disorders       
Anxiety  1  2/62 (3.23%)  12/312 (3.85%)  19/286 (6.64%) 
Depression  1  2/62 (3.23%)  36/312 (11.54%)  35/286 (12.24%) 
Irritability  1  4/62 (6.45%)  41/312 (13.14%)  31/286 (10.84%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  0/62 (0.00%)  23/312 (7.37%)  11/286 (3.85%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  8/62 (12.90%)  28/312 (8.97%)  26/286 (9.09%) 
Itch  1  9/62 (14.52%)  50/312 (16.03%)  44/286 (15.38%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
Phone: +41 61 6878333
EMail: global.trial_information@roche.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01280656    
Other Study ID Numbers: ML22995
First Submitted: January 20, 2011
First Posted: January 21, 2011
Results First Submitted: August 2, 2016
Results First Posted: September 26, 2016
Last Update Posted: November 29, 2016