Prevention of Disease Progress in Chronic Hepatitis C Patients With Liver Fibrosis (Study P02570AM2)(COMPLETED)

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

PHASE3

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2009-10-31

Brief Summary

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

The objective of the study is to evaluate the safety and efficacy of PEG-Intron versus no treatment for the prevention of fibrosis progression in adult participants with moderate to severe liver fibrosis secondary to chronic hepatitis C, who failed PEG-Intron plus Rebetol treatment in protocol P02370 (NCT00039871).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Long-term Peg Intron vs. Colchicine in Non-responders.

NCT00179413

Hepatitis C Virus Advanced Fibrosis Cirrhosis

COMPLETED PHASE4

A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C

NCT03420768

Hepatic Cirrhosis Liver Fibrosis

COMPLETED PHASE2

A Study of FG-3019 in Subjects With Liver Fibrosis Due to Chronic Hepatitis B Infection

NCT01217632

Liver Fibrosis Due to Chronic Hepatitis B Infection

TERMINATED PHASE2

A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis

NCT03486912

Hepatic Cirrhosis Liver Fibrosis Nonalcoholic Fatty Liver Disease (NAFLD) +1 more

COMPLETED PHASE2

Fecal Microbiota Transplantation (FMT) in Nonalcoholic Steatohepatitis(NASH). A Pilot Study

NCT02469272

Nonalcoholic Fatty Liver Disease

UNKNOWN PHASE1

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.

Chronic Hepatitis C Liver Fibrosis

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

PEG-Intron (peginterferon alfa-2b) 0.5 µg/kg Weekly (QW)

PEG-Intron 0.5 µg/kg Weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up

Group Type EXPERIMENTAL

peginterferon alfa-2b (SCH 54031)

Intervention Type BIOLOGICAL

0.5 µg/kg Weekly QW SC for 36 months

Untreated Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

peginterferon alfa-2b (SCH 54031)

0.5 µg/kg Weekly QW SC for 36 months

Intervention Type BIOLOGICAL

Eligibility Criteria

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

Inclusion Criteria

* Age at entry in study P02370 (NCT00039871) 18-65 years;
* Nonresponder to PEG-Intron plus Rebetol in study P02370

Exclusion Criteria

* Participants who did not participate in the P02370 study.
* Any medical condition, including but not limited to decompensated liver disease, malignancy or substance abuse, that developed during the P02370 study which could interfere with the participant's participation in and completion of this study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No