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

NCT00048724 | Completed Phase 3 Results DMC

• 1 other identifier: P02569
• Study Type: interventional
• Target: 631
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Hepatitis C; Cirrhosis

Keywords

Hepatitis C; Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Time to Observation of the Disease Progression Experienced by a Subject

  Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event

Study Arms (2)

PegIntron

EXPERIMENTAL

PegIntron (peginterferon alfa-2b) 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up

Biological: peginterferon alfa-2b (SCH 54031)

Untreated Control

NO INTERVENTION

Interventions

peginterferon alfa-2b (SCH 54031) BIOLOGICAL

0.5 µg/kg subcutaneously once weekly for 60 months

Also known as: PegIntron

PegIntron

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Bruix J, Poynard T, Colombo M, Schiff E, Burak K, Heathcote EJ, Berg T, Poo JL, Mello CB, Guenther R, Niederau C, Terg R, Bedossa P, Boparai N, Griffel LH, Burroughs M, Brass CA, Albrecht JK; EPIC3 Study Group. Maintenance therapy with peginterferon alfa-2b does not prevent hepatocellular carcinoma in cirrhotic patients with chronic hepatitis C. Gastroenterology. 2011 Jun;140(7):1990-9. doi: 10.1053/j.gastro.2011.03.010. Epub 2011 Mar 17.

  PMID: 21419770 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic; Fibrosis; Hepatitis C

Interventions

peginterferon alfa-2b

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2002
• First Posted: November 8, 2002
• Study Start: June 1, 2002
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: April 4, 2017
• Results First Posted: June 11, 2009

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share