Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P07614)
Status: | Terminated |
---|---|
Conditions: | Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 3 - 17 |
Updated: | 4/21/2016 |
Start Date: | January 2012 |
End Date: | March 2013 |
Assessment of the Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (Phase 1b); Protocol No. P07614
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.
following single oral dose administration in Chronic Hepatitis C Virus (HCV) pediatric
participants.
Inclusion Criteria:
- 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 Criteria:
- 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
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