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

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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.


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
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262
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from
Omaha, NE
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801
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Atlanta, GA
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402
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Aurora, CO
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Baltimore, MD
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683
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Birmingham, AL
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1444
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Boston, MA
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1043
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Chapel Hill, NC
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726
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Cincinnati, OH
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810
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Columbus, OH
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349
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Dallas, TX
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346
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Fort Worth, TX
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643
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Indianapolis, IN
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1168
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Los Angeles, CA
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657
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Louisville, KY
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970
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Morgantown, WV
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618
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Nashville, TN
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1290
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New York, NY
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8590
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Newcastle,
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1225
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Philadelphia, PA
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418
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Saint Louis, MO
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583
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San Antonio, TX
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1339
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San Francisco, CA
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1410
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Seattle, WA
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1127
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Washington,
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