A Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection



Status:Recruiting
Conditions:Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:3 - 17
Updated:3/14/2019
Start Date:March 20, 2017
End Date:August 27, 2022
Contact:ABBVIE CALL CENTER
Email:abbvieclinicaltrials@abbvie.com
Phone:847.283.8955

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An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection

An open-label study to assess the pharmacokinetics (PK), safety, and efficacy of glecaprevir
(GLE)/pibrentasvir (PIB) in pediatric participants divided into 4 age groups: 3 to < 6, 6 to
< 9, 9 to < 12, and 12 to < 18 years of age. Within each age group, some participants will be
enrolled for intensive pharmacokinetics (IPK) to characterize the PK of a particular age
group and the remainder of participants will be enrolled for the evaluation of safety and
efficacy of each age group. Intensive PK sampling is designed to allow for dose adjustment,
based on available PK and clinical data to achieve therapeutic exposures that have been safe
and efficacious in adults.

Part 1 of the study will enroll participants into Cohort 1; Cohort 1 will include
participants who are in 12 to < 18 years of age who can swallow the adult formulation of
GLE/PIB. Part 2 of the study will enroll participants in the remaining age groups into
Cohorts 2, 3, and 4; participants in these cohorts will receive the pediatric formulation of
GLE/PIB. All participants will receive GLE/PIB for 8, 12, or 16 weeks depending on their
hepatitis C virus (HCV) genotype, cirrhosis, and prior treatment experience status.


Inclusion Criteria:

- Hepatitis C virus (HCV) infection demonstrated by positive anti-HCV antibody (Ab) and
HCV Ribonucleic acid (RNA) greater than or equal to 1000 IU/ mL.

- Subject must have a weight consistent with a recommended weight range for their age at
the time of screening.

Exclusion Criteria:

- Females who are pregnant or breastfeeding.

- Positive test result for Hepatitis B surface antigen (HbsAg) or positive test result
for HBV DNA.

- Participants with other known liver diseases.

- Decompensated cirrhosis defined as: presence of ascites, history of variceal bleeding,
lab values consistent with Child's class B or C cirrhosis.
We found this trial at
16
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1600 Southwest Archer Road
Gainesville, Florida 32610
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13123 East 16th Avenue
Aurora, Colorado 80045
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300 Longwood Avenue
Boston, Massachusetts 02115
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Boston, Massachusetts 02118
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Chapel Hill, North Carolina 27514
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Hartford, Connecticut 06106
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Houston, TX
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Indianapolis, Indiana 46202
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Nashville, Tennessee 37232
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New York, New York 10032
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601 East Rollins Street
Orlando, Florida 32803
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Philadelphia, Pennsylvania 19104
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Pittsburgh, Pennsylvania 15213
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San Francisco, California 94158
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Woluwe-Saint-Lambert, Bruxelles-Capitale
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