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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Liver Fibrosis; Chronic Hepatitis C

Treatments: Biological: peginterferon alfa-2b (SCH 54031)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00049842

P02570

Details and patient eligibility

About

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).

Enrollment: 540 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

540 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Biological: peginterferon alfa-2b (SCH 54031)

Untreated Control

No Intervention group