Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection



Status:Completed
Conditions:Infectious Disease, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:3 - 17
Updated:9/28/2018
Start Date:July 7, 2014
End Date:September 13, 2018

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A Phase 2, Open-Label, Multicenter, Multi-cohort, Single-Arm Study to Investigate the Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection

This study will have two parts as follows:

The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and
confirm the dose of sofosbuvir (SOF) in hepatitis C virus (HCV)-infected pediatric
participants. The PK Lead-in Phase will also evaluate the safety and tolerability of 7 days
of dosing of SOF+ribavirin (RBV) in HCV-infected pediatric participants.

The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate SOF
dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the
Treatment Phase with no interruption of study drug administration. The Treatment Phase will
evaluate the antiviral efficacy, safety, and tolerability of SOF+RBV for 12 or 24 weeks in
pediatric participants with genotype 2 or 3 HCV infection, respectively.


Key Inclusion Criteria:

- Consent of parent or legal guardian required

- Chronic HCV infection genotype 2 or 3

- Screening laboratory values within defined thresholds

- PK Lead-in only: all individuals must be treatment naive

Key Exclusion Criteria:

- History of clinically significant illness or any other medical disorder that may
interfere with subject treatment, assessment or compliance with the protocol

- Co-infection with HIV, acute hepatitis A virus, or hepatitis B virus

- Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)

- Pregnant or nursing females

- Known hypersensitivity to study medication

- Use of any prohibited concomitant medications as within 28 days of the Day 1 visit

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
17
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