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):
Reckitt Benckiser Pharmaceuticals Inc.
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
|Genders 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.
No Contacts or Locations Provided
No publications provided
||Reckitt Benckiser Pharmaceuticals Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 17, 2006
||November 21, 2012
||Austria: Federal Ministry for Health and Women
Keywords provided by Reckitt Benckiser Pharmaceuticals Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 20, 2014
Hepatitis C, Chronic
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
Physiological Effects of Drugs
Angiogenesis Modulating Agents