Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/-Ribavirin in Adolescents and Children With Chronic HCV-Infection
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Infectious Disease, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 3 - 17 |
| Updated: | 10/25/2018 |
| Start Date: | November 5, 2014 |
| End Date: | August 24, 2018 |
A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/-Ribavirin in Adolescents and Children With 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 ledipasvir/sofobuvir (LDV/SOF) fixed dose combination (FDC) in hepatitis
C virus (HCV)-infected pediatric participants. The PK Lead-in Phase will also evaluate the
safety, tolerability, and antiviral activity of 10 days of dosing of LDV/SOF FDC in
HCV-infected pediatric participants.
The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate
LDV/SOF FDC 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 LDV/SOF FDC +/-
Ribavirin (RBV) for 12 or 24 weeks in pediatric participants with HCV.
The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and
confirm the dose of ledipasvir/sofobuvir (LDV/SOF) fixed dose combination (FDC) in hepatitis
C virus (HCV)-infected pediatric participants. The PK Lead-in Phase will also evaluate the
safety, tolerability, and antiviral activity of 10 days of dosing of LDV/SOF FDC in
HCV-infected pediatric participants.
The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate
LDV/SOF FDC 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 LDV/SOF FDC +/-
Ribavirin (RBV) for 12 or 24 weeks in pediatric participants with HCV.
Key Inclusion Criteria:
- Consent of parent or legal guardian required
- Chronic HCV infection
- Screening laboratory values within define thresholds
Key Exclusion Criteria:
- History of clinically significant illness or any other medical disorder that may
interfere with individual's treatment, assessment or compliance with the protocol.
- Co-infection with HIV, acute hepatitis A virus, or hepatitis B virus
- Clinical hepatic decompensation (i.e., 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
24
sites
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