Effects of Low-dose Maintenance Peg Interferon Alfa-2b Therapy Versus Supportive Care in Patients With Cirrhotic Hepatitis C With HIV (Study P04371)

A Randomized, Open-label, Multi-center, Phase 3, 2-arm Study Evaluating the Efficacy and Safety of Peg Interferon Alfa-2b Low-dose Maintenance Monotherapy Versus Standard Supportive Care in Patients With Cirrhotic Hepatitis C Co-infected With Human Immunodeficiency Virus - The ENDURE Study

NCT00381017•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

This is a Phase 3b, randomized, open-label, parallel-group, multi-center, multi-national study of low-dose maintenance Peg interferon alpha-2b (Peg-Intron®) in subjects with human immunodeficiency virus-hepatitis C virus (HIV-HCV) co-infection. The primary objective is to compare at end of study the efficacy of Peg-Intron® monotherapy (0.5 µg/kg subcutaneously once weekly for 24-36 months) versus standard supportive care, using the time to any of the following clinical events (death, decompensation, liver transplant, hepatocellular carcinoma \[HCC\]) as endpoints.

Eligibility

Age

18 - 69 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age at least 18 years but \< 70 years, of either sex or any race.
•Detectable plasma hepatitis C virus (HCV) RNA (all genotypes of HCV are permitted).
•Cirrhosis of the liver within the last five years.
•Compensated liver disease (Child-Pugh \<8 with hepatic encephalopathy \<= 1.
•No evidence of hepatocellular carcinoma (HCC) and a serum alpha fetoprotein (AFP) \<100 ng/mL within two months of randomization/study enrollment.
•Varices results via endoscopy within the last six months or at time of screening.
•Serologic evidence of human immunodeficiency virus-1.
•CD4 cell count \>=100 /µL.
•Platelet number of at least 50000 mm\*\*3.
•Neutrophil count of at least 750 mm\*\*3.
+10 more criteria

Exclusion Criteria

•Female who is pregnant, intends to become pregnant during the study or within two months after study completion, or is nursing. Male subject whose partner wants to become pregnant.
•Using silymarin.
•Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or HBeAg.
•Any cause of liver disease other than chronic hepatitis C.
•Suspected or having hypersensitivity to interferon.
•History of liver decompensation status or other evidence of bleeding from esophageal varices, signs of current bleeding, significant ascites, hepatic encephalopathy, jaundice or other conditions consistent with decompensated liver disease.
•Present with a lesion suspicious for hepatic malignancy on the screening imaging.
•Any active malignant disease, suspicion, or history of malignant disease within 5 years prior to study enrollment (except for adequately treated basal cell carcinoma).
•Known coagulation or hemoglobin diseases.
•Organ transplant, except corneal or hair transplant.
+5 more criteria

Key Dates

Start Date

September 1, 2006

Last Updated

August 13, 2014

Conditions

Hepatitis CLiver CirrhosisHIV Infections

Interventions

Peg interferon alpha-2b

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 13, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effects of Low-dose Maintenance Peg Interferon Alfa-2b Therapy Versus Supportive Care in Patients With Cirrhotic Hepatitis C With HIV (Study P04371)

Inclusion Criteria

Exclusion Criteria

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