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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00381017
• Date of registration: 26/09/2006
• Primary sponsor: Schering-Plough
• Public title: Effects of Low-Dose Maintenance Peg Interferon Alfa-2b Therapy Versus Supportive Care in Patients With Cirrhotic Hepatitis C With HIV (Study P04371)
• Scientific 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.
• Date of first enrolment: September 2006
• Target sample size: 448
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT00381017
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 69 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hepatitis C

HIV Infections

Liver Cirrhosis

Intervention(s)

Drug: Peg interferon alpha-2b

Secondary ID(s)

EUDRACT NUMBER:2005-003876-39

P04371

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Integrated Therapeutics Group