Chronic hepatitis C genotype one infection Infections and Infestations Chronic hepatitis C genotype one infection
Conditions
Interventions
Adapted therapy duration from 24 to 72 with peginterferon alfa-2b plus ribavirin.
Sponsors
Saarland University Hospital (Universitätsklinikum des Saarlandes) (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with a chronic HCV infection (HCV antibodies and HCV RNA positive) 2. Presence of a HCV genotype one infection 3. Presence of a compensated liver disease satisfying following hematological and biochemical minimum criteria: a. Haemoglobin value more than or equal to 13 g/dl in men, more than or equal to 12 g/dl in women b. Leukocytes more than or equal to 3.000/mm^3 or neutrophil granulocytes more than 1.500/mm^3 c. Thrombocytes more than 80.000/mm^3 4. Total bilirubin in the normal range 5. Albumin in the normal range 6. Serum creatinine in the normal range 7. Thyroid Stimulating Hormone (TSH) in the normal range 8. Exclusion of an autoimmune hepatitis 9. Alpha-Fetoprotein in the normal range 10. Negative Human Immunodeficiency Virus (HIV) test 11. Negativity of Hepatitis B surface antigens (HBsAg) 12. Normal or elevated ALT/Glutamic Pyruvic Transaminase (GPT) values at screening 13. At known diabetes mellitus or hypertension an ophthalmologic examination must be performed 14. Liver biopsy within the last 12 months must confirm the diagnoses of a chronic hepatitis 15. A confirmation must be given that sexually active patients practice a save method of contraception during the therapy and six (women) to seven (men) months after the therapy
Exclusion criteria
Exclusion criteria: 1. Aged under 18 years, or over 70 years 2. Previous treatment of hepatitis C with (peg)interferon alfa or (peg)interferon alfa/ribavirin 3. Patients with organ transplantations other than cornea or hair 4. Infection with HCV genotype two, three, four, five or six 5. Pregnant or nursing women 6. Any other reason for the liver disease than chronic hepatitis C 7. Suspected hypersensitivity to interferon, peginterferon or ribavirin 8. Participation in a clinical trial or treatment with an investigational product 30 days before inclusion in this study 9. Patients with any kind of hemoglobinopathy 10. Documented liver disease in advanced state liver cirrhosis (Child-Pugh classes B and C) 11. Such known and existing clinical conditions that might challenge the participation or completion of this clinical trial such as depressions, psychosis, severe psychiatric diseases, suicide ideations, Central Nervous System (CNS) traumata or cramps which need medicamentous treatment 12. Relevant cardiovascular dysfunctions in the last six months or patients with clinically relevant changes in their Electrocardiogram (ECG) 13. Insufficiently adjusted diabetes mellitus 14. Severe chronic lung diseases (as e.g. Chronic Obstructive Pulmonary Disease [COPD]) 15. Immunologic diseases or autoimmune diseases or any other disease which demands a long-time treatment with corticosteroids during this clinical trial 16. Clinically relevant gout 17. Abuse of drugs, alcohol or pharmaceuticals 18. Patient with clinically relevant changes of the retina 19. Missing ability or willingness to understand the purpose of this study or to give a written consent for participating in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained viral response (HCV RNA negativity 24 weeks after end of treatment). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients with a normal GPT level 24 weeks after end of treatment (sustained biochemical response rate) 2. Percentage of patients with HCV RNA negativity at the end of the therapy (virological end of treatment response rate) 3. Percentage of patients with a normal GPT level at the end of the therapy (biochemical end of treatment response rate) 4. Explorative examination of pretherapeutic parameters | — |
Countries
Germany
Outcome results
None listed