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A Study of the Effectiveness of Peginterferon Alfa-2a (Pegasys) and Ribavirin Treatment in Slovenian Hepatitis C (HCV) Patients

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ClinicalTrials.gov Identifier: NCT02556307
Recruitment Status : Completed
First Posted : September 22, 2015
Results First Posted : February 15, 2016
Last Update Posted : February 15, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Hepatitis C, Chronic
Interventions Drug: Peginterferon alfa-2a
Drug: Ribavirin
Enrollment 270
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Peginterferon Alfa-2a + Ribavirin
Hide Arm/Group Description Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current summaries of product characteristics (SPCs)/local labeling.
Period Title: Overall Study
Started 270
Treated 268
Completed 217
Not Completed 53
Reason Not Completed
Premature treatment interruption             11
Lost to Follow-up             36
Change to triple therapy             4
Enrolled but not treated             2
Arm/Group Title Peginterferon Alfa-2a + Ribavirin
Hide Arm/Group Description Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
Overall Number of Baseline Participants 268
Hide Baseline Analysis Population Description
All treated participants were included in the analysis.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 268 participants
37.7  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 268 participants
Female
71
  26.5%
Male
197
  73.5%
1.Primary Outcome
Title Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment
Hide Description SVR was defined as participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of treatment. Undetectable HCV RNA was defined as a single last HCV RNA less than (<) 20 international units per milliliter (IU/mL). SVR was evaluated based on HCV genotype (G1, G2, G3 and G4), participant's interleukin 28B genotype (CC, CT and TT), and previous treatment (treatment naive or previous treatment).
Time Frame 6 months after the last study drug administration (up to 123.6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants were included in the analysis. Here, 'n' specifies the number of participants included in the analysis as per the specified category (genotype or previous treatment).
Arm/Group Title Peginterferon Alfa-2a + Ribavirin
Hide Arm/Group Description:
Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
Overall Number of Participants Analyzed 268
Measure Type: Number
Unit of Measure: percentage of participants
All participants (n=268) 66
G1 (n=104) 51
G2 (n=9) 67
G3 (n=153) 75
G4 (n=2) 100
CC (n=56) 66
CT (n=73) 66
TT (n=25) 64
Treatment-naive (n=238) 70
Pre-treated (n=30) 30
2.Secondary Outcome
Title Percentage of Participants With Undetectable HCV RNA
Hide Description Undetectable HCV RNA=a single last HCV RNA <20 IU/mL
Time Frame Weeks 4, 12 and at end of treatment (up to 99.6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants were included in the analysis.
Arm/Group Title Peginterferon Alfa-2a + Ribavirin
Hide Arm/Group Description:
Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
Overall Number of Participants Analyzed 268
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 64
Week 12 21
End of treatment 79
3.Secondary Outcome
Title HCV RNA Values
Hide Description [Not Specified]
Time Frame Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed=treated participants with data available for HCV RNA. Here, "n" specifies number of participants with data available for specified category.
Arm/Group Title Peginterferon Alfa-2a + Ribavirin
Hide Arm/Group Description:
Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
Overall Number of Participants Analyzed 267
Mean (Standard Deviation)
Unit of Measure: IU/mL
Baseline (n=267) 3281922  (6039339)
Week 4 (n=262) 44174  (192056)
Week 12 (n=219) 21342  (189967)
End of treatment (n=224) 39436  (335382)
6 months post treatment (n=195) 93414  (852266)
4.Secondary Outcome
Title Thrombocyte Values
Hide Description [Not Specified]
Time Frame Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed=treated participants with data available for thrombocyte value. Here, "n" specifies number of participants with data available for specified category.
Arm/Group Title Peginterferon Alfa-2a + Ribavirin
Hide Arm/Group Description:
Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
Overall Number of Participants Analyzed 265
Mean (Standard Deviation)
Unit of Measure: billion cells per liter
Baseline (n=265) 206  (62.7)
Week 4 (n=260) 143  (55.0)
Week 12 (n=217) 125  (48.0)
End of treatment (n=224) 140  (59.0)
6 months post treatment (n=198) 207  (56.0)
5.Secondary Outcome
Title Leukocyte Values
Hide Description [Not Specified]
Time Frame Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed=treated participants with data available for leukocyte value. Here, "n" specifies number of participants with data available for specified category.
Arm/Group Title Peginterferon Alfa-2a + Ribavirin
Hide Arm/Group Description:
Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
Overall Number of Participants Analyzed 265
Mean (Standard Deviation)
Unit of Measure: billion cells per liter
Baseline (n=265) 7.0  (2.1)
Week 4 (n=260) 3.8  (1.4)
Week 12 (n=217) 3.4  (1.4)
End of treatment (n=224) 3.6  (1.8)
6 months post treatment (n=198) 7.1  (3.5)
6.Secondary Outcome
Title Hemoglobin Values
Hide Description [Not Specified]
Time Frame Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed=treated participants with data available for hemoglobin. Here, "n" specifies number of participants with data available for specified category.
Arm/Group Title Peginterferon Alfa-2a + Ribavirin
Hide Arm/Group Description:
Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
Overall Number of Participants Analyzed 265
Mean (Standard Deviation)
Unit of Measure: gram per liter
Baseline (n=265) 147  (14.4)
Week 4 (n=260) 129  (16.0)
Week 12 (n=260) 129  (16.0)
End of treatment (n=224) 122  (16.0)
6 months post treatment (n=198) 143  (14.0)
7.Secondary Outcome
Title Treatment Duration (in Weeks) With Peginterferon Alfa-2a and Ribavirin
Hide Description [Not Specified]
Time Frame Up to 99.6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants were included.
Arm/Group Title Peginterferon Alfa-2a + Ribavirin
Hide Arm/Group Description:
Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
Overall Number of Participants Analyzed 268
Mean (Standard Deviation)
Unit of Measure: weeks
Peginterferon alfa-2a 31.0  (17.1)
Ribavirin 31.3  (17.2)
Time Frame From signature of informed consent to end of treatment (up to 99.6 weeks)
Adverse Event Reporting Description All treated participants were included.
 
Arm/Group Title Peginterferon Alfa-2a + Ribavirin
Hide Arm/Group Description Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
All-Cause Mortality
Peginterferon Alfa-2a + Ribavirin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Peginterferon Alfa-2a + Ribavirin
Affected / at Risk (%)
Total   4/268 (1.49%) 
General disorders   
Sudden death NOS * 1  1/268 (0.37%) 
Infections and infestations   
Sepsis * 1  1/268 (0.37%) 
Nervous system disorders   
Headache * 1  1/268 (0.37%) 
Psychiatric disorders   
Depressive disorder * 1  1/268 (0.37%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Peginterferon Alfa-2a + Ribavirin
Affected / at Risk (%)
Total   15/268 (5.60%) 
Blood and lymphatic system disorders   
Leucopenia * 1  15/268 (5.60%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.0
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
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
Phone: 800 821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02556307     History of Changes
Other Study ID Numbers: ML22263
First Submitted: September 21, 2015
First Posted: September 22, 2015
Results First Submitted: January 18, 2016
Results First Posted: February 15, 2016
Last Update Posted: February 15, 2016