Buprenorphine Versus Methadone Maintenance in Hepatitis C Patients Receiving Peg-Intron and Rebetol (Study P04279)(TERMINATED)
This study has been terminated.
(The trial was terminated because of deviations from the protocol.)
AESCA Pharma GmbH
Information provided by (Responsible Party):
First received: January 17, 2006
Last updated: November 21, 2012
Last verified: February 2007
This randomized, single-center, controlled study is designed to evaluate the safety, tolerability, and efficacy of treatment with Peg-Intron with Rebetol in methadone or buprenorphine maintenance patients with hepatitis C.
Hepatitis C, Chronic
Drug: pegylated interferon alfa-2b plus ribavirin
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
||Randomized, Controlled Study of Buprenorphine and Methadone in Hepatitis C Patients in Need of Treatment
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2007 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 65 Years (Adult)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- Male and female patients with a history of intravenous drug abuse, who are willing to undergo methadone or buprenorphine substitution.
- Patients with newly diagnosed chronic hepatitis C.
- Age 18-65.
- Hepatitis C virus (HCV)-ribonucleic acid (RNA) positive in serum as measured by polymerase chain reaction (PCR) within the last 4 weeks.
- Genotype 2 or 3.
- Elevated alanine aminotransferase (ALT) levels.
- In women of child-bearing age, pregnancy must be excluded prior to entry into the study, and the use of a safe contraceptive device (intrauterine device, oral contraceptive, diaphragm + spermicide, condom + spermicide, tubal ligation) must be documented.
- Hemoglobin: >=12 g/dL (women) or >=13 g/dL (men)
- Leukocytes >=3,000/µL
- Thrombocytes >=100,000/µL
- Prothrombin time (PT)/partial thromboplastin time (PTT)/coagulation within the normal range
- Albumin: not more than 10% deviation from lower normal value
- Thyroid-stimulating hormone (TSH) normal
- Creatinine normal
- Uric acid normal
- Antinuclear antibodies <=1:160
- Signed informed consent.
- Refusal by women of child-bearing age or by sexually active patients to use a safe contraceptive.
- Breast-feeding women.
- Cirrhosis stage B and C according to Child-Pugh.
- Signs of decompensated liver disease (ascites, bleeding varices and spontaneous encephalopathy).
- Confirmed co-infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV).
- Existing psychiatric comorbidity.
- Alcohol abuse.
- Active malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma).
- Existing psoriasis or other dermatological disorder (relative exclusion criterion: due to great differences with regard to the severity of the disorder and the individual therapy compatibility, the therapy decision is at the discretion of the physician).
- Treatment with a study drug within the last 30 days.
- Any uncontrolled underlying medical conditions (e.g. diabetes).
- Clinically significant electrocardiogram (ECG) abnormalities and / or significant cardiovascular dysfunction within the last 6 months (angina, heart failure, recent myocardial infarction, severe hypertension or significant arrhythmia) is an exclusion criterion. In case of other suspected heart disease, a cardiologic examination is required prior to inclusion of the patient.
- Any liver disorder of other genesis than the study indication (with regard to elevated iron levels, only patients with manifest hemochromatosis are excluded).
- Autoimmune disorder (except LKM-positive patients: these patients may be included in the study).
- Misuse of buprenorphine or methadone.
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History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 17, 2006
||November 21, 2012
Keywords provided by Indivior Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 17, 2017
Hepatitis C, Chronic
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Central Nervous System Depressants