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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00048724
First received: November 6, 2002
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C
Cirrhosis
Biological: peginterferon alfa-2b (SCH 54031)
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Time to Observation of the First Clinical Event Experienced by a Subject [ Time Frame: Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Time to Observation of the Disease Progression Experienced by a Subject [ Time Frame: Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 631
Study Start Date: June 2002
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PegIntron
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)
0.5 µg/kg subcutaneously once weekly for 60 months
Other Name: PegIntron
No Intervention: Untreated Control

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00048724     History of Changes
Other Study ID Numbers: P02569
Study First Received: November 6, 2002
Results First Received: April 23, 2009
Last Updated: April 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Hepatitis C; Cirrhosis

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Liver Cirrhosis
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Peginterferon alfa-2b
Anti-Infective Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014