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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00048724
Recruitment Status : Completed
First Posted : November 8, 2002
Results First Posted : June 11, 2009
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 631 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2002
Primary Completion Date : April 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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 ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
More Information

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
First Posted: November 8, 2002    Key Record Dates
Results First Posted: June 11, 2009
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


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

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