Chronic hepatitis C of genotype 2 or 3 Infections and Infestations Hepatitis
Conditions
Interventions
Application of:
a. 1.5 µg/kg Peg-Interferon alpha-2b subcutaneously (sc) + 800-1200 mg ribavirin orally (po) weight adapted for 24 weeks
b. 1.0 µg/kg Peg-Interferon alp
Sponsors
Medical University Hannover (Medizinische Hochschule Hannover), Kompetenznetz Hepatitis (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Haemoglobin >12 g/kl (females); >13 g/kl (males); Platelet count >100,000/mm^3; Neutrophil count >1500/mm^3; Adult male or female chronic hepatitis C (CHC) patients (HCV-RNA-positive in serum) with compensated liver disease (Child-Pugh Score 18 to <70 years of age; at least one abnormal ALT value in the last year; HCV genotype 2 or 3; not previously treated with any interferon or ribavirin alone or in combination; TSH level within normal limits; Women of childbearing potential: negative pregnancy test performed at baseline; Sexually active female subjects of childbearing potential: adequate contraception or monogamous relationship with a male partner who has had a vasectomy or is using a condom (+ spermicide) during the treatment period and for seven months after stopping treatment; Sexually active male subjects: acceptable methods of contraception(vasectomy, use of condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for seven months after stopping treatment; written informed consent.
Exclusion criteria
Exclusion criteria: Patients younger than 18 years; Patients older than 70 years of age; Anti-human immunodeficiency virus (HIV) positivity; HBsAg-positivity; existence of, or a history of severe psychiatric condition, particularly severe depression, suicidal ideation of suicide attempt; Autoimmune hepatitis; or history of autoimmune disease; patients with severe renal dysfunction or creatinine clearance <50 ml/min; active drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained HCV-virological response (HCV-RNA negative in serum by a standard HCV-PCR with a detection limit of at least 600 IU/ml) 24 weeks after the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Virological response rates (HCV-RNA negative in serum by a standard HCV-PCR with a detection limit of at least 600 IU/ml) at the end of therapy; biochemical responses as determined by ALT and AST levels at the end of treatment and at the end of follow up; severity and frequency of adverse events; quality of life (assessed by SF-36). | — |
Countries
Germany
Outcome results
None listed