A Study of Ribavirin in Combination With PEGASYS (Peginterferon Alfa-2a (40KD))in Patients With Chronic Hepatitis C

NCT ID: NCT00922779

Last Updated: 2016-01-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

6661 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This single arm study will evaluate the safety and tolerability of ribavirin in combination with PEGASYS in patients with chronic hepatitis C. Patients will receive ribavirin 800mg, or 1000-1200mg po daily, according to HCV genotype and body weight (\< and \>75kg)in combination with PEGASYS 180micrograms sc weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is \>500 individuals.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis C, Chronic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

peginterferon alfa-2a [Pegasys]

Intervention Type DRUG

180micrograms sc weekly for 12-48 weeks

ribavirin

Intervention Type DRUG

800mg, or 1000-1200mg, po daily (dependent on HCV genotype and body weight)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

peginterferon alfa-2a [Pegasys]

180micrograms sc weekly for 12-48 weeks

Intervention Type DRUG

ribavirin

800mg, or 1000-1200mg, po daily (dependent on HCV genotype and body weight)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* adult patients, \>=18 years of age;
* serological evidence of chronic hepatitis C;
* detectable serum HCV-RNA;
* liver biopsy findings consistent with a diagnosis of chronic hepatitis C.

Exclusion Criteria

* history or other evidence of a medical condition associated with chronic liver disease other than HCV;
* co-infection with active hepatitis A or B;
* hepatocellular carcinoma;
* patients with severe cardiovascular disease whose condition may worsen due to acute anemia.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Arkhangelsk, , Russia

Site Status

Barnaul, , Russia

Site Status

Barnaul, , Russia

Site Status

Blagoveshchensk, , Russia

Site Status

Cheboksary, , Russia

Site Status

Chelyabinsk, , Russia

Site Status

Chelyabinsk, , Russia

Site Status

Chelyabinsk, , Russia

Site Status

Cherepovets, , Russia

Site Status

Chita, , Russia

Site Status

Irkutsk, , Russia

Site Status

Irkutsk, , Russia

Site Status

Irkutsk, , Russia

Site Status

Izhevsk, , Russia

Site Status

Kazan', , Russia

Site Status

Kemerovo, , Russia

Site Status

Kemerovo, , Russia

Site Status

Kemerovo, , Russia

Site Status

Khabarovsk, , Russia

Site Status

Khabarovsk, , Russia

Site Status

Khabarovsk, , Russia

Site Status

Kirov, , Russia

Site Status

Krasnodar, , Russia

Site Status

Krasnodar, , Russia

Site Status

Krasnodar, , Russia

Site Status

Krasnoyarsk, , Russia

Site Status

Krasnoyarsk, , Russia

Site Status

Lipetsk, , Russia

Site Status

Makhachkala, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Nizhny Novgorod, , Russia

Site Status

Novokuznetsk, , Russia

Site Status

Novokuznetsk, , Russia

Site Status

Novosibirsk, , Russia

Site Status

Novoural'sk, , Russia

Site Status

Omsk, , Russia

Site Status

Orenburg, , Russia

Site Status

Petropavlovsk-Kamchatskiy, , Russia

Site Status

Rostov-on-Don, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Salekhard, , Russia

Site Status

Samara, , Russia

Site Status

Samara, , Russia

Site Status

Saratov, , Russia

Site Status

Saratov, , Russia

Site Status

Saratov, , Russia

Site Status

Sashi, , Russia

Site Status

Stavropol, , Russia

Site Status

Surgut, , Russia

Site Status

Tomsk, , Russia

Site Status

Tyumen, , Russia

Site Status

Tyumen, , Russia

Site Status

Tyumen, , Russia

Site Status

Tyumen, , Russia

Site Status

Ufa, , Russia

Site Status

Ufa, , Russia

Site Status

Ulan-Ude, , Russia

Site Status

Vladivostok, , Russia

Site Status

Vladivostok, , Russia

Site Status

Volgograd, , Russia

Site Status

Volgograd, , Russia

Site Status

Yakutsk, , Russia

Site Status

Yekaterinburg, , Russia

Site Status

Yekaterinburg, , Russia

Site Status

Yekaterinburg, , Russia

Site Status

Yujno-sakhalinsk, , Russia

Site Status

Yujno-sakhalinsk, , Russia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Russia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ML16709

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.