Chronic Hepatitis C
Conditions
Interventions
Trade Name: Copegus 200 mg
Product Name: Copegus 200 mg
Product Code: Ro 20-9963
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ribavirin
Concentration unit: mg milligram(s)
Concentratio
Sponsors
Roche Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation and comparison of HCV RNA virus kinetic models with various asumptions to the Ribavirin mechanism of action based on the various forms and phases of treatment;Secondary Objective: 1. Comparison of the treatment arms by comparing the kinetic parameters of the various treatment groups 2. Influence of Ribavirin saturation compared to placebo on the initial virological response (quantitative HCV RNA measuring using Cobas Ampliprep/Cobas TaqMan (Detection limit 12 IU/ml, Roche Diagnostics, Mannheim) after 12 weeks of combination treatment 3. Correlation of the virus kinetics with the GPT kinetics and test parameters for mutagenesis, immunology, predictive host factors and pharmacokinetics 4. Evaluation of various parameters that could be invoked in addition to body weight to determine the optimum Ribavirin dosage;Primary end point(s): The primary objective of this pilot trial is the evaluation and comparison of different HCV-RNA virus kinetic models with various hypotheses to the Ribavirin mechanism of effect, in order to estimate, with an optimized model, a possible advantage of preliminary treatment with Ribavirin on the virological response, even with a few number of patients. At first, model adjustments should be compared using the individual response effects regarding the level of infection (model 1), virus production (model 2) and/or the reduction rate of infected cells (model 3), if possible using variance analysis or the non-parametric Friedman test. | — |
Countries
Germany
Outcome results
None listed