Dose Escalation Study to Evaluate the Safety and Antiviral Activity of Val-mCyd in Adults With Chronic Hepatitis C
Phase 1
Completed
- Conditions
- Chronic Hepatitis C
- Registration Number
- NCT00227435
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This study was conducted to determine the safety, tolerance, pharmacokinetics and antiviral activity of val-mCyd at doses ranging from 50 mg to 800 mg per day.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Documented clinical history of chronic hepatitis C and compensated liver disease
- No antiviral treatment for hepatitis C in the 6 months prior to the Screening visit
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Patient is pregnant or breastfeeding
- Patient is co-infected with HBV or HIV
Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Val-mCyd's inhibition of HCV NS5B polymerase activity?
How does Val-mCyd's antiviral efficacy compare to pegylated interferon and ribavirin in HCV genotype 1 patients?
Which biomarkers predict response to Val-mCyd in chronic hepatitis C based on NCT00227435 data?
What adverse events were observed in NCT00227435 and how do they compare to other nucleoside analogs for HCV?
Are there synergistic effects when combining Val-mCyd with direct-acting antivirals like protease inhibitors for HCV treatment?