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An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Copegus (Ribavirin) in Participants With Chronic Hepatitis C (CHC), Genotype 2, 3, 1 or 4, Undergoing Opioid Maintenance Therapy (PEGHOPE)

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ClinicalTrials.gov Identifier: NCT01416610
Recruitment Status : Completed
First Posted : August 15, 2011
Results First Posted : December 9, 2015
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Hepatitis C, Chronic
Enrollment 88
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Participants
Hide Arm/Group Description Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
Period Title: Overall Study
Started 88
Intention to Treat 88
Safety Population 86
Per Protocol 83
Completed Treatment 47
Completed Follow-up 45
Completed 45
Not Completed 43
Reason Not Completed
Adverse Event             4
Adverse Event -Patient decision             3
Lack of Efficacy             4
No reason given             5
Withdrawal by Subject             13
Lost to Follow-up             7
Sufficient treatment duration (PCR neg.)             7
Arm/Group Title All Participants
Hide Arm/Group Description Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
Overall Number of Baseline Participants 88
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 88 participants
34.6  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants
Female
24
  27.3%
Male
64
  72.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Austria Number Analyzed 88 participants
88
1.Primary Outcome
Title Percentage of Participants With Sustained Virological Response 24 Weeks After Completing Treatment (SVR24)
Hide Description SVR24 is defined as percentage of participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment, using a last observation carried forward (LOCF) approach. Percentage is based on the number of non-missing observations (total).
Time Frame 24 weeks after completing treatment, within 3 years, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
Overall Number of Participants Analyzed 88
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
83.0
(73.8 to 89.4)
2.Secondary Outcome
Title Percentage of Participants With SVR 12
Hide Description SVR 12 is defined as percentage of participants with undetectable HCV RNA 12 weeks after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total).
Time Frame 12 weeks after completing treatment, within 3 years, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
Overall Number of Participants Analyzed 88
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
81.8
(72.5 to 88.5)
3.Secondary Outcome
Title Percentage of Participants With End of Treatment Response
Hide Description A participant was considered to have end of treatment response if there was undetectable HCV RNA after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total).
Time Frame at end of treatment, within 3 years, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
Overall Number of Participants Analyzed 88
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
87.5
(79.0 to 92.9)
4.Secondary Outcome
Title Percentage of Participants With Virological Relapse
Hide Description Virological relapse is defined as no SVR24 in a participant with undetectable HCV RNA at end of treatment who has at least one post-treatment polymerase chain reaction (PCR) result available, using a LOCF approach. Percentage is based on the number of non-missing observations (total).
Time Frame by end of follow-up, within 3 years, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed treatment
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
Overall Number of Participants Analyzed 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
10.6
(4.6 to 22.6)
5.Secondary Outcome
Title Short Form Health Survey (SF-36) Scores by Visit
Hide Description The SF-36 questionnaire items were scored and transformed according to the SF-36 Health Survey Manual & Interpretation Guide. Summary scores for SF-36 dimensions of physical functioning, role functioning, bodily pain, general health, vitality, social functioning, and mental health were scored on a scale of 0 (worst) to 100 (best), and health transition was scored on a scale of 0 (worst) to 5 (best). Summary SF-36 scores are reported by category and by visit.
Time Frame at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a viable score at the given time point
Arm/Group Title Baseline Week 12 End of Treatment End of Follow-up
Hide Arm/Group Description:
Baseline Visit
Week 12 Visit
End of Treatment Visit
End of Follow-up Visit
Overall Number of Participants Analyzed 88 88 88 88
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physical Functioning (n=54,34,37,22) 77.9  (21.7) 63.5  (25.1) 62.7  (22.3) 76.1  (26.5)
Role Functioning - Physical (n=52,34,37,22) 60.6  (40.9) 32.4  (37.7) 24.3  (37.0) 70.5  (39.1)
Bodily Pain (n=53,35,37,22) 70.8  (27.7) 58.7  (29.3) 52.5  (27.8) 75.4  (29.7)
General Health (n=50,35,36,22) 50.9  (18.9) 46.1  (18.6) 50.5  (18.7) 65.4  (19.3)
Vitality (n=52,35,37,22) 42.8  (21.5) 26.1  (19.3) 33.9  (20.2) 48.6  (20.0)
Social Functioning (n=53,35,37,23) 69.8  (27.1) 52.5  (28.6) 48.0  (27.4) 72.3  (32.6)
Role Functioning – Emotional (n=53,34,36,22) 57.2  (44.0) 31.4  (37.6) 31.5  (36.5) 69.7  (37.0)
Mental Health (n=52,34,37,22) 59.1  (19.2) 49.4  (19.8) 51.7  (22.4) 67.2  (25.7)
Reported Health Transition (n=54,34,37,22) 3.3  (1.2) 3.6  (1.2) 3.2  (1.5) 2.0  (1.2)
6.Secondary Outcome
Title Fatigue Severity Scale (FSS) Score by Visit
Hide Description The Fatigue Severity Scale (FSS) consists of 9 questions, each answered within a range of 1-7, where lower scores indicate less fatigue in everyday life. The FSS score is the mean of the 9 numbers. Mean scores are presented by visit.
Time Frame at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a viable score at the given time point
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
Overall Number of Participants Analyzed 88
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=56) 4.0  (1.4)
Week 12 (n=35) 5.0  (1.3)
End of treatment (n=37) 5.0  (1.4)
End of follow-up (n=24) 3.8  (1.8)
7.Secondary Outcome
Title Beschwerdeliste (BL) Score by Visit
Hide Description The BL questionnaire items were scored by calculating the average response to all answered items. Items can be graded 1="stark" (affliction is strong) to 4="gar nicht" (not present). The higher the BL score, the less afflictions were present for a participant. Mean scores are presented by visit.
Time Frame at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a viable score at the given time point
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
Overall Number of Participants Analyzed 88
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=59) 3.1  (0.5)
Week 12 (n=34) 2.8  (0.5)
End of treatment (n=36) 2.7  (0.5)
End of follow-up (n=24) 3.1  (0.6)
8.Secondary Outcome
Title Beck Depression Inventory (BDI) Score by Visit
Hide Description The BDI questionnaire items were scored by generating the sum of the responses to all answered items. Each result was categorized into one of four categories: 0-13= no depression or clinically not significant or in remission; 14-19= mild depression; 20-28= moderate depression; or 29-63= severe depression. Mean scores are presented by visit.
Time Frame at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a viable score at the given time point
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
Overall Number of Participants Analyzed 88
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=50) 13.7  (9.0)
Week 12 (n=33) 18.4  (11.1)
End of treatment (n=33) 16.9  (9.4)
End of follow-up (n=22) 11.6  (10.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Safety Population
Hide Arm/Group Description Participants who started treatment
All-Cause Mortality
Safety Population
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Safety Population
Affected / at Risk (%)
Total   14/86 (16.28%) 
Blood and lymphatic system disorders   
Anaemia  1  2/86 (2.33%) 
General disorders   
Drug withdrawal syndrome  1  2/86 (2.33%) 
Hepatobiliary disorders   
Cholelithiasis  1  1/86 (1.16%) 
Infections and infestations   
Abscess limb  1  1/86 (1.16%) 
Erysipelas  1  1/86 (1.16%) 
Herpes zoster  1  1/86 (1.16%) 
Pneumonia  1  1/86 (1.16%) 
Musculoskeletal and connective tissue disorders   
Osteoarthritis  1  1/86 (1.16%) 
Psychiatric disorders   
Anorexia nervosa  1  1/86 (1.16%) 
Withdrawal syndrome  1  1/86 (1.16%) 
Reproductive system and breast disorders   
Uterine cyst  1  1/86 (1.16%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  1  1/86 (1.16%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Safety Population
Affected / at Risk (%)
Total   60/86 (69.77%) 
Blood and lymphatic system disorders   
Anaemia  1  15/86 (17.44%) 
Gastrointestinal disorders   
Nausea  1  13/86 (15.12%) 
General disorders   
Fatigue  1  42/86 (48.84%) 
Influenza like illness  1  14/86 (16.28%) 
Pyrexia  1  10/86 (11.63%) 
Investigations   
Weight decreased  1  8/86 (9.30%) 
Metabolism and nutrition disorders   
Decreased appetite  1  15/86 (17.44%) 
Musculoskeletal and connective tissue disorders   
Myalgia  1  6/86 (6.98%) 
Nervous system disorders   
Headache  1  14/86 (16.28%) 
Psychiatric disorders   
Depression  1  23/86 (26.74%) 
Insomnia  1  6/86 (6.98%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  9/86 (10.47%) 
Dry skin  1  6/86 (6.98%) 
Pruritus  1  6/86 (6.98%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
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: Medical Communications
Organization: Hoffmann-La Roche
Phone: 1-800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01416610    
Other Study ID Numbers: ML25159
First Submitted: August 12, 2011
First Posted: August 15, 2011
Results First Submitted: November 4, 2015
Results First Posted: December 9, 2015
Last Update Posted: April 10, 2017