Randomized, multicentric, partially double blind placebo-controlled phase II study for examining the influence of Ribavirin on the initial virological response in previous untreated patients with chronic Hepatitis C Virus Genotype 1 infection receiving treatment of Peginterferon alfa-2a (40KD) and Ribavirin with a six week pretreatment-phase of Ribavirin/placebo or PEG-Interferon monotherapy - RIKI

• Conditions: Chronic Hepatitis C; Genotype 1 Infection; MedDRA version: 8.1Level: HLTClassification code 10057212Term: Hepatitis viral infections

• Registration Number: EUCTR2006-000935-86-DE
• Lead Sponsor: Roche Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-28
• Last Update Posted: 22 October 2012

Recruitment & Eligibility

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

Inclusion Criteria

1. Serological evidence of chronic hepatitis C infection with positive anti-HCV test and evidence of HCV-RNA in the serum
2. Evidence of genotype HCV-1 based on the reverse hybridisation assay Inno LiPA from Bayer Versant (Innogenetics);
3. If possible, histological evidence of inflammatory activity in the liver with or without evidence of compensated cirrhosis (Child-Pugh grade A) during the 24 months before the start of the study or evaluation of liver fibrosis by transient elastography (FibroScan)
4. Untreated patients with chronic HCV infection
5. Caucasian men and women aged from 18 to 70 years
6. Negative urine or serum pregnancy test in women of childbearing potential within 24 hours before taking the first dose of the drug
7. Whilst taking the drug and for fertile female patients during the 16 weeks after discontinuation and for fertile female partners of a patient during the 28 weeks after last study-drug application, two safe methods of contraception must be used, one of which must be a condom worn by the man to provide an effective barrier
8. Informed consent for participation on the clinical trial, signed by patient
9. For all patients an ophtalmological examination is indicated during the screening period for documentation of baseline-status
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Known hypersensitivity to interferon or Ribavirin or any other ingredients
2. Patients who are underage or patients who are incapable to understand the aim, importance and consequences of the study and to give legal informed consent (according to § 40 Abs. 4 and § 41 Abs. 2 und Abs. 3 AMG)
3. Women lactating, pregnant or of childbearing potential not using a highly effective contraceptive method (allowed methods of birth control, i.e. with a failure rate of less than 1 % per year, are implants, injectables, combined oral contraceptives, IUDs (only hormonspirals), sexual abstinence or vasectomized partner. Women of childbear-ing potential must have a negative pregnancy test (serum, ß-HCG) at visit 0 (Baseline))
4. Male partners of pregnant women
5. Patients who participates currently in another clinical trial or patients who participated in another clinical trial within the last 3 months
6. Patients who have participated in this study before
7. Patients who possibly are dependent on the sponsor or investigator
8. Infection with HCV-Genotype-2, -3, -4, -5 or -6
9. Previous treatment with interferon and/or Ribavirin
10. Positive evidence of HBsAg, HIV-antibodies in the screening phase
11. Immune suppressed patients
12. Treatment with systemic antineoplastic drugs or immunomodulators (including supraphysiological doses of steroids or radiation) within the last six months before the start of the study and throughout the whole study
13. Chronic hepatitis not caused by hepatitis virus C (such as haemochromatosis, autoimmune hepatitis, liver disease caused by metabolic disorder or alcohol)
14. Decompensated cirrhosis of the liver or liver disease Child-Pugh grade B or C or condition following decompensation
15. Signs of hepatocellular carcinoma within two months before the randomization because of the presence of cirrhosis or transition into cirrhosis
16. Ascites or history of oesophageal varices with bleeding
17. Haemoglobin of <13 g/dl for women or <14 g/dl for men in the screening phase
18. Patients with increased risk of anaemia (such as thalassaemia, spherocytosis, etc.) or patients for whom anaemia would signify a particular medical risk
19. Neutropenia <1,500/mcl or thrombocytopenia <90,000/mcll diagnosed in the screening phase
20. Serum creatinine >1.5 mg/dl in the screening phase
21. Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study
22. History of severe psychiatric illness, particularly severe depression. Severe psychiatric illness is defined as any history of at least three months continuous antidepressive or antipsychotic treatment or any evidence of suicidal tendency or referral to hospital as a result of psychiatric illness
23. Epilepsy
24. Autoimmune disease such as chronic inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosis, sclerodema, severe psoriasis, rheumatoid arthritis, etc.
25. Disorders of thyroid gland function that could not be controlled with euthyroid medication
26. Insufficiently controlled diabetes mellitus (HbA1c >8,5%)
27. Clinically manifest gout.
28. Chronic pulmonary disease with functional limitation
29. Previous severe heart disease such as heart failure NYHA class III or IV, myocardial infarction within the last six months, ventricular tachycardia requiring treatment, unstable angina, cerebrovascular perfusion disorders or other significant cardiovascular disease

Study & Design

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