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

Phase 3

Completed

• Conditions: Chronic Hepatitis C; Liver Fibrosis
• Interventions: Biological: peginterferon alfa-2b (SCH 54031)

• Registration Number: NCT00049842
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Study First Submitted: 2002-11-14
• Study First Submitted QC: 2002-11-14
• Study First Posted: 2002-11-15
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Results First Submitted: 2010-10-07
• Results First Submitted QC: 2010-12-17
• Results First Posted: 2011-01-20
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-07
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 540

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEG-Intron (peginterferon alfa-2b) 0.5 µg/kg Weekly (QW)	peginterferon alfa-2b (SCH 54031)	PEG-Intron 0.5 µg/kg Weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up

Primary Outcome Measures

Name	Time	Method
Fibrosis Response Status (ie, Improvement, no Change, or the Worsening of the Fibrosis Score in Participants With Baseline METAVIR Fibrosis Score of F2 or F3).	Baseline to up to Month-36	Definitions: Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis).; Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline.; No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score.; Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Inflammation Response Status (ie, Improvement, no Change, or the Worsening of the METAVIR Activity Score as Compared to Baseline)	Baseline to up to Month-36	Activity Scoring: A0 (no histological activity), A1 (minimal activity), A2 (moderate activity), A3 (severe activity), A4 (lobular chronic hepatitis).; Changes in liver inflammation defined as follows: Improved: Participants whose METAVIR activity score at up to Month-36 decreases by 1 or more units compared to baseline.; No Change: Participants whose METAVIR activity score at up to Month-36 is the same as the baseline score.; Worsened: Participants whose METAVIR activity score at up to Month-36 increases by 1 or more units compared to baseline.
Mean Change From Baseline to up to Month-36 in the METAVIR Fibrosis Score (Using a Continuous Scale)	Baseline to up to Month-36	The change of Metavir Fibrosis Score = Metavir Fibrosis Score at up to Month-36 - Metavir Fibrosis Score at Baseline.; Fibrosis scoring: 0 (no fibrosis), 1 (stellate enlargement of portal tract without septa formation, 2 (enlargement of portal tract with rare septa formation, 3 (numerous septa without cirrhosis), 4 (cirrhosis).
The Number of Participants Whose METAVIR Fibrosis Score Did Not Worsen (ie, the Response Status of Improved/no Change) During Treatment Compared to Baseline	Baseline to up to Month-36	Definitions: Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis).; Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline.; No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score.; Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline.
Mean Change in the METAVIR Activity Score (Using a Continuous Scale)	Baseline to up to Month-36	The change of Metavir Activity Score = Metavir Activity Score at up to Month-36 - Metavir Activity Score at Baseline.; Activity Scoring: 0 (no histological activity), 1 (minimal activity), 2 (moderate activity), 3 (severe activity), 4 (lobular chronic hepatitis).
Number of Participants With no Worsening (ie, the Response Status of Improved/ no Change) in the METAVIR Activity Score During the Treatment.	Baseline to up to Month-36	Definitions: Activity Scoring: A0 (no histological activity), A1 (minimal activity), A2 (moderate activity), A3 (severe activity), A4 (lobular chronic hepatitis).; Improved: Participants whose METAVIR activity score at up to Month-36 decreases by 1 or more units compared to baseline.; No Change: Participants whose METAVIR activity score at up to Month-36 is the same as the baseline score.; Worsened: Participants whose METAVIR activity score at up to Month-36 increases by 1 or more units compared to baseline.