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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01416610
First received: August 12, 2011
Last updated: November 4, 2015
Last verified: November 2015
  Purpose
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.

Condition
Hepatitis C, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Percentage of Participants With SVR 12 [ Time Frame: 12 weeks after completing treatment, within 3 years, 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 88
Study Start Date: April 2010
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
All Participants
Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with chronic hepatitis C (CHC), Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416610

Locations
Austria
Gratwein, Austria, 8112
Graz, Austria, 8036
Innsbruck, Austria, 6020
Klagenfurt, Austria, 9020
Linz, Austria, 4010
Wien, Austria, 1030
Wien, Austria, 1090
Wien, Austria, 1100
Wien, Austria, 1160
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01416610     History of Changes
Other Study ID Numbers: ML25159 
Study First Received: August 12, 2011
Results First Received: November 4, 2015
Last Updated: November 4, 2015
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Analgesics, Opioid
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 24, 2016