A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Enrolled in a Methadone Maintenance Treatment Program.

This study has been completed.

First Received on July 12, 2004. Last Updated on June 1, 2010 History of Changes

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00087594

Purpose

This study will evaluate the safety and tolerability of PEGASYS plus ribavirin in previous intravenous (iv) drug users who have CHC and are currently enrolled in a methadone maintenance treatment program. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.

Condition	Intervention	Phase
Hepatitis C, Chronic	Drug: peginterferon alfa-2a [Pegasys] Drug: ribavirin	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Open Label, Multi-center, Randomized Safety, Feasibility and Tolerability Pilot Study of Pegasys® (Peginterferon Alfa-2a) Copegus® (Ribavirin) in Previous Intravenous Drug Users Who Are Currently Enrolled in a Methadone Maintenance Treatment Program.

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Ribavirin Methadone Peginterferon Alfa-2a Methadone hydrochloride

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Treatment completion rate [ Time Frame: Week 24/48 ] [ Designated as safety issue: No ]
AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Beck Depression Inventory, HQLQ, SVR, biochemical response. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	48
Study Completion Date:	October 2006

Arms	Assigned Interventions
Experimental: 1	Drug: peginterferon alfa-2a [Pegasys] 180 micrograms sc weekly for 24 weeks (G 2/3) or 48 weeks (G 1) Drug: ribavirin 1000/1200mg po daily for 24 weeks (G 2/3) or 48 weeks (G 1)
Experimental: 2	Drug: peginterferon alfa-2a [Pegasys] 180 micrograms sc weekly for 24 weeks (G 2/3) or 48 weeks (G 1) Drug: ribavirin 1000/1200mg po daily for 24 weeks (G 2/3) or 48 weeks (G 1)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients at least 18 years of age
CHC infection, genotype 1, 2, or 3
naive to treatment for CHC infection
enrolled in a methadone maintenance program with documented attendance for at least 3 months
use of 2 forms of contraception during the study on both men and women

Exclusion Criteria:

previous treatment for CHC infection
co-infection with human immunodeficiency virus (HIV)
current use of IV or other illicit drugs
decompensated cirrhosis
women who are pregnant or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00087594

Locations

United States, California

San Francisco, California, United States, 94121
United States, Connecticut

Farmington, Connecticut, United States, 06030
United States, Hawaii

Honolulu, Hawaii, United States, 96813
United States, Illinois

Downers Grove, Illinois, United States, 60515
United States, Maryland

Baltimore, Maryland, United States, 21205
United States, New York

New York, New York, United States, 10003
United States, Virginia

Richmond, Virginia, United States, 23249

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00087594 History of Changes
Other Study ID Numbers:	ML17251
Study First Received:	July 12, 2004
Last Updated:	June 1, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Methadone
Ribavirin

Peginterferon alfa-2a
Interferon-alpha
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics
Antiviral Agents

ClinicalTrials.gov processed this record on February 09, 2012