Hepatitis C Virus (HCV) genotype one Infections and Infestations Hepatitis C Virus (HCV) genotype one
Conditions
Interventions
Arm A: blood letting treatment until the required target ferritin level is reached (Ferritin more than or equal to 50 µg/l to less than or equal to 100 µg/l) but only until a maximum of 24 weeks is re
Sponsors
Heinrich Heine University Hospital (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years 2. Serological evidence of chronic HCV genotype one infection with positive anti-HCV test 3. Evidence of a serum HCV-RNA concentration more than 10,000 IU/ml during screening measured with the COBAS AmpliPrep/COBAS TaqMan HCV Test (lower limit of detection 10 IU/ml) 4. No previous antiviral treatment 5. Ferritin level more than 200 µg/l 6. Liver puncture less than 24 months before the start of treatment 7. Compensated liver disease (Child - Pugh Grade A; evaluated in accordance with the clinical classification of patients with cirrhosis) 8. In patients with cirrhosis or in transition to cirrhosis an ultrasound of the abdomen or another established method of excluding Hepatocellular Carcinoma (HCC) must be carried out within two months before the randomisation and the serum Alpha-Fetoprotein (AFP) value must be less than 100 ng/ml. In patients with a serum AFP value of more than 50 ng/ml, an established procedure must be used to exclude HCC 9. Negative urine or serum pregnancy test in women of childbearing age within 24 hours before taking the first dose of the drug 10. Whilst taking the study medication and during the 24 weeks after discontinuation, two recognised methods of contraception must be used, one of which must be a condom worn by the man to provide an effective barrier 11. The patient must be prepared and in a position for the regular checks within the framework of the trial to be carried out 12. A consent form must be signed after the trial has been explained If one or more of these inclusion criteria do not apply, the patient may not be included in the study.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to peginterferon alfa-2a, alfa-interferons, ribavirin, or one of the other components of the product 2. Patients with any other HCV genotype except for genotype one 3. Women who are pregnant or breast feeding, women of child-bearing age who are not using contraceptives, and male partners of women who are pregnant or women of child-bearing age, who are not using contraceptives 4. Treatment with systemic antineoplastic or immune modulatory drug within the last six months before the start of the study and throughout the study. This includes treatment with histamine, mycophenolate mofetil, thymosin alpha, viramidin, levovirin and supraphysiological doses of steroids or radiation (with the exception of patients who have received limited treatment [seven days or less] of herpes lesions with aciclovir or valaciclovir more than one month before taking the first study medication) 5. Any other study medication within the last six weeks before the start of the first study measures (blood letting) 6. Positive evidence of Immunoglobulin M (IgM) antibodies to hepatitis A virus, hepatitis B surface antigens, IgM to hepatitis B virus, anti-Human Immunodeficiency Virus antibodies in the screening phase 7. Previous history or evidence of non-hepatitis C associated chronic liver disease (e.g. Haemochromatosis, autoimmune hepatitis, metabolic disorder of the liver, alcoholic liver disease or exposure to toxins) 8. Previous history or evidence of decompensated liver disease or a Child - Pugh Score more than six 9. Patients with increased risk of anaemia (such as thalassaemia, spherocytosis, a history of recurrent gastrointestinal bleeding etc.) or patients for whom anaemia would signify a particular medical risk 10. 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 11. Patients with known severe convulsions that cannot be stabilised with drugs 12. Auto-immune disease such as chronic inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosis, autoimmune anaemia, sclerodema, severe psoriasis, rheumatoid arthritis, etc. 13. Chronic pulmonary disease with functional limitation 14. Severe previous heart disease (e.g. heart failure in line with New York Heart Association (NYHA) class III or IV, myocardial infarction within the last six months, ventricular tachycardia requiring treatment, unstable angina, or other significant cardiovascular disease 15. History of organ transplant – excluding cornea transplant 16. Any severe disease, cancer or any other cause that in the estimation of the trial doctor makes the patient appear unsuitable for this study 17. Disorders of thyroid gland function that cannot be controlled with euthyroid medication 18. Evidence of severe retinopathy such as cytomegalovirus retinitis, macular degeneration or any clinically relevant ophthalmological diseases caused by diabetes mellitus or high blood pressure 19. Blood count: neutropenia less than 1,500 cells/µl and thrombocytopenia less than 75,000 cells/µl 20. Serum creatinine more than 1.5 mg/dl 21. Haemoglobin: less than 13 g/dl for men or less than 12 g/dl for women 21. Patients with intraventricular drug abuse or substitution treatment in the last 12 months 22. Patients with signs of hepatoc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of the virus kinetics in the first 12 weeks of peginterferon alfa-2a/ribavirin combination treatment in patients with elevated levels of ferritin and previous blood letting treatment (Arm A) compared to peginterferon alfa-2a/ribavirin combination treatment in patients with elevated ferritin levels without previous blood letting treatment (Arm B). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison of the efficacy (defined as Sustained Virological Response [SVR]) 24 weeks after the end of treatment 2. Improvement of serum fibrosis markers 3. Virological response at week 48 (end of treatment) 4. Early virological response at week 12 5. Safety and compatibility of blood letting treatment in advance of a 48 week combination treatment with peginterferon alfa-2a/ribavirin | — |
Countries
Germany
Outcome results
None listed