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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00039871
First received: June 13, 2002
Last updated: October 30, 2014
Last verified: October 2014

June 13, 2002
October 30, 2014
May 2002
September 2007   (final data collection date for primary outcome measure)
Sustained Virologic Response (SVR) Rate [ Time Frame: Assessed at end of 24 weeks posttreatment follow-up ] [ Designated as safety issue: No ]
Number of participants with undetectable hepatitis C virus RNA (HCV-RNA)
Not Provided
Complete list of historical versions of study NCT00039871 on ClinicalTrials.gov Archive Site
  • Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12 [ Time Frame: 24 weeks posttreatment ] [ Designated as safety issue: No ]
    Number of participants with undetectable HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up
  • Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12 [ Time Frame: 24 weeks posttreatment ] [ Designated as safety issue: No ]
    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
Not Provided
Not Provided
Not Provided
 
PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370)
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)

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).

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis
  • Hepatitis C, Chronic
  • Fibrosis
  • Liver Cirrhosis
  • 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
Experimental: Overall study population
Interventions:
  • Biological: PegIntron (peginterferon alfa-2b; SCH 54031)
  • Drug: REBETOL (ribavirin; SCH 18908)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2333
September 2007
September 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00039871
P02370
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP