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Completed

NCT Number: NCT00039871

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

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).

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PegIntron (peginterferon alfa-2b; SCH 54031)

Biological

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 names: SCH 54031

REBETOL (ribavirin; SCH 18908)

Drug

REBETOL (ribavirin) administered on a weight basis: 800-1400 mg/day orally (PO) for up to 48 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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)

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Jun 14, 2002
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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