chronic hepatitis C, genotype 1
Conditions
Interventions
Trade Name: Peg Intron
Product Name: Peg Intron
Product Code: SCH 54031
Pharmaceutical Form: Injection*
INN or Proposed INN: PEGINTERFERON ALFA-2B
CAS Number: 215647-85-1
Current Sponsor code: SCH 540
Sponsors
AESCA Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •• male and female patients with chronic hepatitis C with no prior HCV therapy • age 18-65 • HCV-RNA positive in serum as measured by PCR • Genotype 1 • ALT levels according to European labeling • in women of child-bearing age, pregnancy must be excluded prior to entry into the study, and the use of a safe contraceptive device (intrauterine device, oral contraceptive, diaphragm + spermicide, condom + spermicide, tubal ligation) must be documented • sexually active male subjects must practice a method of contraception considered acceptable (vasectomy, condom plus spermicide, plus relationship with a female partner who practices an acceptable method of contraception) • Lab parameters: Hb: =12 g/dl (women) or = 13 g/dl (men) leukocytes = 3,000/µl thrombocytes = 100,000/µl • PT/PTT/coagulation must be within normal limits or clinically acceptable to the investigator/sponsor • Albumin must be within normal limits or clinically acceptable to the investigator/sponsor • creatinine must be within normal limits or clinically acceptable to the investigator/sponsor • uric acid must be within normal limits or clinically acceptable to the investigator/sponsor • antinuclear antibodies = 1:160 • signed informed consent 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •refusal by women of child-bearing age or by sexually active patients to use a safe contraceptive •breast-feeding women •cirrhosis stage B and C according to Child-Pugh •signs of decompensated liver disease (ascites, bleeding varices and spontaneous encephalopathy) •confirmed co-infection with HIV or HBV •existing psychiatric comorbidity •alcohol abuse •active malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of Early Virological Response Rates (>=2 log drop in week 12 or PCR neg) in patients with and without insuline resistance ;Secondary Objective: Evaluation of prolonged treatment duration in late virological responders (>=2 log drop in week 12, but not PCR neg) Evaluation of SVR Rates in patients with and without insuline resistance Safety and toxicity ;Primary end point(s): Comparison of Early Virological Response Rates (>=2 log drop in week 12 or PCR neg) in patients with and without insuline resistance | — |
Countries
Austria
Outcome results
None listed