Hepatitis C MedDRA version: 9.1 Level: LLT Classification code 10019744 Term: Hepatitis C
Conditions
Interventions
Trade Name: Peg-Intron
Pharmaceutical Form: Powder and solvent for solution for injection
Trade Name: Rebetol
Pharmaceutical Form: Capsule, hard
Sponsors
Malmö University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Registered in a clinic providing maintenence therapy for opiate dependence at the date of study initiation. 2. HCV-PCR positive. 3. At least 6 months of uninterrupted maintenence therapy for opiate dependence. 4. Treatment indication with at least one of the following: fibrosis/cirrhosis and/or other HCV related disease/symptoms and/or psychological indication. 5. For patients with cirrhosis, un ultrasound investigation should be performed within six months before study initiation (not showing signs of HCV). 6. Use of adequate contraception during the treatment period and for six months after the completion of therapy (for all participants regardless of gender). 7. Written informed consent and able to adhere to dosing and visiting schedules. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant women, women who plan to become pregnant, male subjects whose partner wants to become pregnant, and breastfeeding women. 2. Previous treatment for chronic hepatitis C with an antiviral or immunomodulating agent or with an interferon or ribavirin product, whether alone or in combination. 3. Participation in another clinical drug trial. 4. Coinfection with HBV or HIV. 5. Hemoglobin10 mg prednisone/day), immunosuppressive drugs, chemotherapy) and/or treatment with herbal drugs for chronic hepatitis 18. Any other condition which in the opinion of the investigator would make the patient unsuitable for enrolment, or could interfere with the patient participating in and completing the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine completion rates of HCV treatment with pegylated interferon-alfa-2b and ribavirin in patients who are under opiate maintenance treatment and eligible for HCV therapy.;Secondary Objective: To investigate the: 1. Prevalence of chronic hepatitis C, genotype distribution and genetic relationship between HCV isolates in the patient population eligible for part 1 of the study. 2. clinical and histological characteristics of chronic hepatitis C in the patient population. 3. prevalence of hepatic decompensation and cirrhosis/advanced liver disease in the patient population. 4. risk factors for advanced liver disease in the patient population 5. proportion of sustained virological responders in the patient population. 6. rates of relapse in opiate drug abuse. 7. prevalence of depressive symptoms and assessment of quality of life before, under and after HCV treatment. 8. potential pharmacokinetic interactions between ribavirin and methodone or buprenorphine. ;Primary end point(s): Completion rates of HCV treatment, defined as having received the last prescribed dose of study medication (including patients who interrupt treatment prematurely due to virological non-response according to protocol criteria). The completion rate will be calculated as the number of patients having completed the study according to the definition abouve divided by the number of patients having been prescribed medication. | — |
Countries
Sweden
Outcome results
None listed