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PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370)

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ClinicalTrials.gov Identifier: NCT00039871
Recruitment Status : Completed
First Posted : June 14, 2002
Results First Posted : December 11, 2008
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The objective of this study is to determine the effectiveness of PEG-Intron 1.5 ug/kg/wk plus REBETOL (ribavirin) 800-1400 mg/day in adults with chronic hepatitis C with moderate to severe liver fibrosis or cirrhosis who failed to respond to previous treatment with an alpha interferon in combination with ribavirin. Patients who do not respond to PEG-Intron plus REBETOL (ribavirin) will be enrolled in a long-term maintenance study to evaluate the effectiveness of PEG-Intron monotherapy versus no treatment for the prevention of disease progression (Protocols P02569 and P02570).

Condition or disease Intervention/treatment Phase
Hepatitis Hepatitis C, Chronic Fibrosis Liver Cirrhosis Biological: PegIntron (peginterferon alfa-2b; SCH 54031) Drug: REBETOL (ribavirin; SCH 18908) Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2333 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PEG-Intron Plus REBETOL for the Treatment of Subjects With Chronic Hepatitis C Who Failed to Respond to Previous Combination Therapy (Any Alpha Interferon Treatment in Combination With Ribavirin)
Study Start Date : May 2002
Primary Completion Date : September 2007
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Overall study population Biological: PegIntron (peginterferon alfa-2b; SCH 54031)
PegIntron (peginterferon alfa-2b) administered at a dose of 1.5 mcg/kg subcutaneously (SC) once a week (QW) for up to 48 weeks
Other Name: SCH 54031
Drug: REBETOL (ribavirin; SCH 18908)
REBETOL (ribavirin) administered on a weight basis: 800-1400 mg/day orally (PO) for up to 48 weeks


Outcome Measures

Primary Outcome Measures :
  1. Sustained Virologic Response (SVR) Rate [ Time Frame: Assessed at end of 24 weeks posttreatment follow-up ]
    Number of participants with undetectable hepatitis C virus RNA (HCV-RNA)


Secondary Outcome Measures :
  1. Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12 [ Time Frame: 24 weeks posttreatment ]
    Number of participants with undetectable HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up

  2. Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12 [ Time Frame: 24 weeks posttreatment ]
    Number of participants with detectable HCV-RNA but ≥2 log drop from baseline in HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up


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
  • Positive for Hepatitis C
  • Nonresponder to previous treatment (minimum of 3 months) with an alpha Interferon plus ribavirin
  • Liver biopsy demonstrating moderate to severe fibrosis or cirrhosis

Exclusion Criteria:

  • Any cause for the liver disease other than chronic hepatitis C
  • History or presence of complications of cirrhosis
  • Alcohol or illicit drug use or methadone treatment within the past 2 years
  • Treatment for chronic hepatitis C within the previous 6 months
  • Diseases or conditions that could interfere with the subject's participation in and completion of the study
More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00039871     History of Changes
Other Study ID Numbers: P02370
First Posted: June 14, 2002    Key Record Dates
Results First Posted: December 11, 2008
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


Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Peginterferon alfa-2b
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs