Study of Response in Chronic Hepatitis C (CHC) Participants Genotype 1 With Insulin Resistance and Prolonged Treatment Duration in Late Responders (P04823/MK-4031-303)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
male and female participants with newly diagnosed chronic hepatitis C
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 must be documented; sexually active male participants 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
You may not be if
refusal by women of child-bearing age or by sexually active participants to use a safe contraceptive
breast-feeding women
cirrhosis stage B and C according to Child-Pugh
signs of decompensated liver disease
confirmed co-infection with HIV or HBV
existing psychiatric comorbidity
alcohol abuse
active malignant disease or suspicion or history of malignant disease within 5 previous years (except for adequately treated basal cell carcinoma)
existing psoriasis or other dermatological disorder
treatment with a study drug within the last 30 days
any uncontrolled underlying medical conditions
clinically significant ECG abnormalities and/or significant cardiovascular dysfunction within the last 6 months. In case of other suspected heart disease, a cardiological examination is required.
any liver disorder of other genesis than the study indication (with regard to elevated iron levels, only participants with manifest hemochromatosis are excluded)
Clareo Health | Study of Response in Chronic Hepatitis C (CHC) Participants Genotype 1 With Insulin Resistance and Prolonged Treatment Duration in Late Responders (P04823/MK-4031-303)
