Effects of Low-dose Maintenance Peg Interferon Alfa-2b Therapy Versus Supportive Care in Patients With Cirrhotic Hepatitis C With HIV (Study P04371)
Merck Sharp & Dohme Corp.
Integrated Therapeutics Group
Information provided by (Responsible Party)
Merck Sharp & Dohme Corp.
First received: September 26, 2006
Last updated: August 11, 2014
Last Verified: August 2014
History of Changes
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.
Drug : Peg interferon alpha-2b
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
Further study details as provided by Merck Sharp & Dohme Corp.:
|Study Start Date:||September 2006|
|Ages Eligible for Study:||18 Years to 69 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- Hemoglobin of >9.0 mg%.
- Serum thyroid stimulating hormone levels within normal limits, regardless of treatment with L thyroxin.
- Hemoglobin A1c (HbA1c)<8.5%, to demonstrate controlled diabetes, if applicable.
- Written clearance from an ophthalmologist must be presented for subjects with a history of hypertension or diabetes prior to treatment start.
- Creatinine clearance >50 mL/min, as assessed by the indirect calculation method.
- Demonstrate stable status of HIV-1 infection.
- On stable antiretroviral therapy (HAART) for at least 6 weeks prior to baseline, with the expectation of their HAART regimen (drugs and dosage) remaining unaltered for the first 8 weeks of the study OR
- Willing to delay initiation of HAART therapy for at least 6 weeks (for subjects who have not been on HAART for at least 8 weeks prior to randomization). "Structured treatment interruptions" will be permitted during the study.
- Counseled in the appropriate use of birth control while in this study, as confirmed by the principal investigator or a sub-investigator.
- Free of any clinically significant disease (other than HCV and HIV) that would interfere with study evaluations.
- 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.
- Any known preexisting medical condition that, in the investigator's opinion, could interfere with the subject's participation in and completion of the study, such as major depressive disorder.
- Active HIV-related opportunistic infection and/or malignancy requiring systemic therapy.
- Evidence of known severe retinopathy.
- Subject has not observed the designated washout periods for any of the prohibited medications.
- Participating in any other hepatitis C clinical study.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00381017
Sponsors and CollaboratorsMerck Sharp & Dohme Corp.
Integrated Therapeutics Group
|Responsible Party:||Merck Sharp & Dohme Corp.|
|ClinicalTrials.gov Identifier:||NCT00381017 History of Changes|
|Other Study ID Numbers:||P04371|
|Study First Received:||September 26, 2006|
|Last Updated:||August 11, 2014|
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on July 19, 2018
This information is provided by ClinicalTrials.gov.