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 |
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.
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
sites
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