Study to evaluate Response Rates in CHC Patients genotype 1 with Insulin Resistance and to assess prolonged Treatment Duration in late virological Responders

AESCA Pharma GmbH0 个研究点开始时间: 2006年7月26日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

••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

•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)

发起方

AESCA Pharma GmbH