Status:
COMPLETED
Double-Blind, Dose-Escalation Study of IDX184 in Chronic Hepatitis C Treatment-Naïve Subjects
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Chronic Hepatitis C (HCV)
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a proof-of-concept study which will provide data about the safety and antiviral activity of several doses of the investigational drug IDX184 given for 3 days in treatment-naive HCV genotype 1-...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 18-65 years old
- Subject of childbearing potential must agree to use a consistent form of an acceptable double-barrier method of birth control.
- Plasma HCV RNA ≥ 5 log10 IU/mL
- HCV genotype 1
- Exclusion criteria:
- Received prior antiviral treatment for hepatitis C infection
- Subject is pregnant or breastfeeding
- Body Mass Index (BMI) \> 32
- Currently abusing alcohol or illicit drugs
- Currently receiving methadone, buprenorphine or other drugs for the treatment of opioid addiction
- Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human immunodeficiency virus (HIV)
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00807001
Start Date
December 1 2008
End Date
July 1 2009
Last Update
August 19 2016
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