Peg-Intron for Prevention of Disease Progress in Chronic Hepatitis C Patients With Cirrhosis (Study P02569)

Cirrhosis Clinical Trial

Official title:

PEG-Intron as Maintenance Therapy vs. an Untreated Control Group in Adult Subjects With Compensated Cirrhosis (METAVIR F4), Secondary to Chronic Hepatitis C, Who Have Failed to Respond to Therapy With Any Alpha Interferon Plus Ribavirin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00048724
• Other study ID #: P02569
• Status: Completed
• Phase: Phase 3
• First received: November 6, 2002
• Last updated: March 26, 2015
• Start date: June 2002
• Est. completion date: April 2008

Study information

• Verified date: March 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to evaluate the safety and efficacy of PEG-Intron vs. no treatment for the prevention of disease progression in adult subjects with compensated cirrhosis secondary to chronic hepatitis C, who failed to respond to therapy with an a interferon plus ribavirin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 631
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age at entry 18-65 years;

• Non-responders to previous treatment (minimum of 3 months) with an alpha interferon plus ribavirin;

• Liver biopsy demonstrating cirrhosis

Exclusion Criteria:

• Any other cause for liver disease other than chronic hepatitis C;

• History or presence of complications of cirrhosis;

• Alcohol or illicit drug abuse or treatment with methadone within the past 2 years;

• Diseases or conditions that could interfere with participation in the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Cirrhosis
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Liver Cirrhosis

Intervention

Biological:
• peginterferon alfa-2b (SCH 54031)
0.5 µg/kg subcutaneously once weekly for 60 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Observation of the First Clinical Event Experienced by a Subject	Clinical events are liver decompensation [variceal bleeding, development of Child-Pugh Class C, hepatic encephalopathy =Grade 2, ascites], hepatic carcinoma, death, and/or liver transplantation	Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event	Yes
Secondary	Time to Observation of the Disease Progression Experienced by a Subject	Disease progression was observation of any clinical event defined for the primary outcome, plus any of development of Child-Pugh Class B, emergence of varices, or enlargement of pre-existing varices requiring additional therapy.	Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event	Yes