E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019744 |
E.1.2 | Term | Hepatitis C |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Patients will followed until 6 months after completion of therapy, for assessment of SVR. The last study visit will take place seven months after completion. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |