Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Hoffmann-La Roche |
---|---|
Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00087594 |
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 (40KD) [PEGASYS] Drug: ribavirin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study |
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. |
Enrollment: | 48 |
Study Completion Date: | May 2005 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: peginterferon alfa-2a (40KD) [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)
|
2: Experimental |
Drug: peginterferon alfa-2a (40KD) [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)
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | ML17251 |
Study First Received: | July 12, 2004 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00087594 |
Health Authority: | United States: Food and Drug Administration |
Interferon-alpha Liver Diseases Hepatitis, Chronic Interferons Ribavirin Hepatitis, Viral, Human Hepatitis |
Virus Diseases Methadone Digestive System Diseases Peginterferon alfa-2a Hepatitis C Interferon Alfa-2a Hepatitis C, Chronic |
Antimetabolites Anti-Infective Agents RNA Virus Infections Flaviviridae Infections Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances |
Physiological Effects of Drugs Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |