Hepatitis C in a cohort of patients with maintenance therapy for opiate dependence - prevalence, severity and outcome of antiviral therapy

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10019744Term: Hepatitis C; Hepatitis C

• Registration Number: EUCTR2007-001130-13-SE
• Lead Sponsor: Malmö University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-05
• Last Update Posted: 4 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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. Hemoglobin<120 g/L for females and <130g/L for males.
6. LPK<3.0 x109/L
7. Platelets<80 x109/L
8. Creatinin clearance<50mL/min
9. Any of the following diseases considered to be a dominant cause of the patients' liver disease: hemochromatosis, alpha-1 antitrypsin deficiency, Wilson's disease, autoimmune hepatitis, alcoholic liver disease, non-alcoholic steatohepatitis (NASH), drug-related liver disease
10. Active malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma)
11. Subjects with organ transplants, except for corneal or hair transplant
12. Poorly controlled diabetes mellitus
13. Evidence of severe retinopathy or clinically relevant ophtalmological disorder in subjects with diabetes mellitus or hypertension
14. Poorly controlled epilepsy
15. Thyroid dysfunction not adequately controlled
16. Decompensated cirrhosis (Child-Pugh B-C)
17. Treatment with immunomodulatory drugs (cronic systemic corticosteroids (equivalent to >10 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified