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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01416610
First received: August 12, 2011
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This prospective, multi-center, observational study will evaluate the efficacy a nd safety of Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) in patient s with previously untreated chronic hepatitis C, genotype 2, 3, 1 or 4, who are undergoing opioid maintenance therapy. Data will be collected from eligible pati ents receiving Pegasys and Copegus according to SPC/local guidelines for up to 7 2 weeks of treatment and 24 weeks of follow-up.


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® Plus COPEGUS® 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:
  • Sustained virological response (SVR), defined as percentage of patients with undetectable HCV RNA 24 weeks after completing treatment [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Virological response at end of treatment, defined as percentage of patients with undetectable HCV RNA [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Virological relapse, defined as no SVR in patients with undetectable HCV RNA at end of treatment [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Patient compliance [ Time Frame: up to 72 weeks ] [ Designated as safety issue: No ]
  • Quality of life: SF-36 Health Survey/Fatigue Severity Scale/Beck Depression Inventory [ Time Frame: up to 96 weeks ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: April 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Patients undergoing an opioid maintenance therapy
  • Serologic evidence of chronic hepatitis C prior to therapy
  • CHC genotype 1, 4, 2 or 3
  • Quantifiable serum HCV 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 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, 1100
Wien, Austria, 1030
Wien, Austria, 1160
Wien, Austria, 1090
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01416610     History of Changes
Other Study ID Numbers: ML25159
Study First Received: August 12, 2011
Last Updated: August 4, 2014
Health Authority: Austria: Federal Agency for Safety in Health Care (BASG)

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Analgesics, Opioid
Peginterferon alfa-2a
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 28, 2014