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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

Tracking Information
First Submitted Date August 12, 2011
First Posted Date August 15, 2011
Results First Submitted Date November 4, 2015
Results First Posted Date December 9, 2015
Last Update Posted Date April 10, 2017
Study Start Date April 2010
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 4, 2015)
Percentage of Participants With Sustained Virological Response 24 Weeks After Completing Treatment (SVR24) [ Time Frame: 24 weeks after completing treatment, within 3 years, 6 months ]
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).
Original Primary Outcome Measures
 (submitted: August 12, 2011)
Sustained virological response (SVR), defined as percentage of patients with undetectable HCV RNA 24 weeks after completing treatment [ Time Frame: approximately 3 years ]
Change History
Current Secondary Outcome Measures
 (submitted: November 4, 2015)
  • Percentage of Participants With SVR 12 [ Time Frame: 12 weeks after completing treatment, within 3 years, 6 months ]
    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).
  • Percentage of Participants With End of Treatment Response [ Time Frame: at end of treatment, within 3 years, 6 months ]
    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).
  • Percentage of Participants With Virological Relapse [ Time Frame: by end of follow-up, within 3 years, 6 months ]
    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).
  • Short Form Health Survey (SF-36) Scores by Visit [ Time Frame: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months ]
    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.
  • Fatigue Severity Scale (FSS) Score by Visit [ Time Frame: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months ]
    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.
  • Beschwerdeliste (BL) Score by Visit [ Time Frame: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months ]
    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.
  • Beck Depression Inventory (BDI) Score by Visit [ Time Frame: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months ]
    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.
Original Secondary Outcome Measures
 (submitted: August 12, 2011)
  • Virological response at end of treatment, defined as percentage of patients with undetectable HCV RNA [ Time Frame: approximately 3 years ]
  • Virological relapse, defined as no SVR in patients with undetectable HCV RNA at end of treatment [ Time Frame: approximately 3 years ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 3 years ]
  • Patient compliance [ Time Frame: up to 72 weeks ]
  • Quality of life: SF-36 Health Survey/Fatigue Severity Scale/Beck Depression Inventory [ Time Frame: up to 96 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
Official Title A Prospective, Observational, Multicenter Non-interventional Trial Examining Efficacy of Combination Therapy With PEGASYS® (Peginterferon Alfa-2a 40KD) Plus COPEGUS® (Ribavirin) in Patients With Chronic Hepatitis C, Genotype 2, 3, 1 or 4, Undergoing an Opioid Maintenance-Therapy With Special Focus on Patient Compliance and Quality of Life
Brief Summary This prospective, multi-center, observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) in participants with previously untreated chronic hepatitis C, genotype 2, 3, 1 or 4, who are undergoing opioid maintenance therapy. Data will be collected from eligible participants receiving Pegasys and Copegus treatment as prescribed by treating physician and treatment-free follow-up period of 24 weeks.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Participants with chronic hepatitis C (CHC), Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
Condition Hepatitis C, Chronic
Intervention Not Provided
Study Groups/Cohorts All Participants
Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
Publications * Gschwantler M, Laferl H, Vogel W, Korak W, Moser S, Hofer H, Bauer B, Schleicher M, Bognar B, Bischof M, Stauber R, Maieron A, Ferenci P; Austrian Hepatitis Study Group. Efficacy of peginterferon plus ribavirin in patients receiving opioid substitution therapy : Final results of the Austrian PegHope study. Wien Klin Wochenschr. 2018 Jan;130(1-2):54-61. doi: 10.1007/s00508-017-1263-2. Epub 2017 Sep 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 19, 2015)
88
Original Estimated Enrollment
 (submitted: August 12, 2011)
200
Actual Study Completion Date October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult participants, >/= 18 years of age
  • Participants undergoing an opioid maintenance therapy
  • Serologic evidence of CHC prior to therapy
  • CHC genotype 2, 3, 1 or 4
  • Quantifiable serum hepatitis C (HCV) ribonucleic acid (RNA)
  • All fertile males and females receiving ribavirin must use two forms of effective contraception during treatment with study drugs and for 7 months after completion of treatment

Exclusion Criteria:

  • Harmful use of psychoactive substances (including excessive alcohol consumption) that precludes successful participation in the study at the discretion of the investigator
  • Pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of the study
  • Co-infection with hepatitis A, hepatitis B or Human Immunodeficiency Virus (HIV)
  • Current diagnosis of a major depression or any psychotic disorder
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria
Removed Location Countries  
 
Administrative Information
NCT Number NCT01416610
Other Study ID Numbers ML25159
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor Hoffmann-La Roche
Collaborators Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date March 2017