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

Description

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.

Study Start Date

March, 20 2017

Estimated Completion Date

April 2022

Interventions

  • Drug: Glecaprevir/Pibrentasvir

Study ID

AbbVie -- M16-123

Status

Recruiting

Trial ID

NCT03067129

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

110

Sponsor

AbbVie

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.

Gender

All

Ages

3 Years to 17 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (40)

Study Location Distance Name Phone Email
Boston Childrens Hospital ID 157988 - Boston, Massachusetts 2.6 miles None None None
Boston Childrens Hospital ID 157988 - Boston, Massachusetts 2.6 miles None None None
Boston Childrens Hospital ID 157988 - Boston, Massachusetts 2.6 miles None None None
Boston Childrens Hospital ID 157988 - Boston, Massachusetts 2.6 miles None None None
Boston Medical Center ID 157997 - Boston, Massachusetts 3.5 miles None None None
Boston Medical Center ID 157997 - Boston, Massachusetts 3.5 miles None None None
Boston Medical Center ID 157997 - Boston, Massachusetts 3.5 miles None None None
Boston Medical Center ID 157997 - Boston, Massachusetts 3.5 miles None None None
Columbia University ID 158000 - New York, New York 181.2 miles None None None
Columbia University ID 158000 - New York, New York 181.2 miles None None None
Columbia University ID 158000 - New York, New York 181.2 miles None None None
Columbia University ID 158000 - New York, New York 181.2 miles None None None
The Childrens Hospital of Philadelphia CHOP ID 158003 - Philadelphia, Pennsylvania 270.8 miles None None None
The Childrens Hospital of Philadelphia CHOP ID 158003 - Philadelphia, Pennsylvania 270.8 miles None None None
The Childrens Hospital of Philadelphia CHOP ID 158003 - Philadelphia, Pennsylvania 270.8 miles None None None
The Childrens Hospital of Philadelphia CHOP ID 158003 - Philadelphia, Pennsylvania 270.8 miles None None None
Childrens Hospital of Pittsburgh Pennsylvania ID 158004 - Pittsburgh, Pennsylvania 477.6 miles None None None
Childrens Hospital of Pittsburgh Pennsylvania ID 158004 - Pittsburgh, Pennsylvania 477.6 miles None None None
Childrens Hospital of Pittsburgh Pennsylvania ID 158004 - Pittsburgh, Pennsylvania 477.6 miles None None None
Childrens Hospital of Pittsburgh Pennsylvania ID 158004 - Pittsburgh, Pennsylvania 477.6 miles None None None
UNC School of Medicine ID 157991 - Chapel Hill, North Carolina 616.4 miles None None None
UNC School of Medicine ID 157991 - Chapel Hill, North Carolina 616.4 miles None None None
UNC School of Medicine ID 157991 - Chapel Hill, North Carolina 616.4 miles None None None
UNC School of Medicine ID 157991 - Chapel Hill, North Carolina 616.4 miles None None None
Florida Hospital ID 166022 - Orlando, Florida 1,115.8 miles None None None
Florida Hospital ID 166022 - Orlando, Florida 1,115.8 miles None None None
Florida Hospital ID 166022 - Orlando, Florida 1,115.8 miles None None None
Florida Hospital ID 166022 - Orlando, Florida 1,115.8 miles None None None
Unity Point Health Des Moines ID 167164 - Des Moines, Iowa 1,157.4 miles None None None
Unity Point Health Des Moines ID 167164 - Des Moines, Iowa 1,157.4 miles None None None
Unity Point Health Des Moines ID 167164 - Des Moines, Iowa 1,157.4 miles None None None
Unity Point Health Des Moines ID 167164 - Des Moines, Iowa 1,157.4 miles None None None
Texas Childrens Hospital ID 157989 - Houston, Texas 1,609.9 miles None None None
Texas Childrens Hospital ID 157989 - Houston, Texas 1,609.9 miles None None None
Texas Childrens Hospital ID 157989 - Houston, Texas 1,609.9 miles None None None
Texas Childrens Hospital ID 157989 - Houston, Texas 1,609.9 miles None None None
University of California San Francisco ID 158002 - San Francisco, California 2,696.4 miles None None None
University of California San Francisco ID 158002 - San Francisco, California 2,696.4 miles None None None
University of California San Francisco ID 158002 - San Francisco, California 2,696.4 miles None None None
University of California San Francisco ID 158002 - San Francisco, California 2,696.4 miles None None None

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