Status:
TERMINATED
Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P07614)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
3-17 years
Phase:
PHASE1
Brief Summary
This is a study to determine the pharmacokinetics (PK) and weight-based dose of boceprevir following single oral dose administration in Chronic Hepatitis C Virus (HCV) pediatric participants.
Eligibility Criteria
Inclusion
- Documented chronic hepatitis C (CHC) genotype 1 infection
- Treatment naïve or failed previous interferon/ribavirin therapy (≥12 uninterrupted weeks)
- Weigh between 10 kg to 90 kg inclusive at screening and baseline (Day -1).
- Body Mass Index (BMI) from the 5th to the 95th percentile for the participant's age and gender, inclusive, per tables from the Center for Disease Control and Prevention, USA
- Use of acceptable methods of contraception for at least 3 months prior to baseline and continue on study
Exclusion
- Co-infection with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive).
- Treatment with ribavirin within 90 days, or any interferon-alfa within 30 days
- Discontinued from interferon treatment due to adverse events
- Currently receiving antiviral/immunomodulating therapy for hepatitis C
- Prior treatment with an HCV protease inhibitor
- Prior treatment with any known hepatotoxic agent (including herbal remedies)
- Use of investigational drugs within 30 days of enrollment into study
- Evidence of de-compensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
- Substance abuse (including but not limited to alcohol abuse, illicit drugs,
- inhalational drugs, marijuana use, etc) any time prior to entry into the study
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug.
- Pregnant or breastfeeding female
- Meeting any of the laboratory exclusion criteria
Key Trial Info
Start Date :
January 4 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01425190
Start Date
January 4 2012
End Date
March 20 2013
Last Update
September 11 2018
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