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

This study has been withdrawn prior to enrollment.
(Non-protocol feasibility)
Sponsor:
Collaborator:
Integrated Therapeutics Group
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00381017
First received: September 26, 2006
Last updated: June 19, 2007
Last verified: June 2007

September 26, 2006
June 19, 2007
September 2006
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Complete list of historical versions of study NCT00381017 on ClinicalTrials.gov Archive Site
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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)
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.

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.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis C
  • Liver Cirrhosis
  • HIV Infections
Drug: Peg interferon alpha-2b
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
448
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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.
  • 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.

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.
  • 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.
Both
18 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00381017
P04371, EUDRACT NUMBER:2005-003876-39
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Schering-Plough
Integrated Therapeutics Group
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Schering-Plough
June 2007

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