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Summary

for people ages 3–17 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

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

Keywords

Hepatitis C Virus (HCV) Chronic Hepatitis C Virus Glecaprevir Pibrentasvir Pharmacokinetic Treatment naïve Treatment experienced Interferon (IFN) pegylated interferon (pegIFN) Ribavirin (RBV) sofosbuvir Non-cirrhotic cirrhosis Compensated (Child-Pugh A) cirrhosis Hepatitis Hepatitis A Hepatitis C Hepatitis, Chronic Hepatitis C, Chronic Interferons

Eligibility

You can join if…

Open to people ages 3–17

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Univ of California San Francis accepting new patients
    San Francisco, California, 94158, United States
  • BC Children's Hospital and Res not yet accepting patients
    Vancouver, British Columbia, V6H 3V4, Canada
  • Childrens Hospital Colorado accepting new patients
    Aurora, Illinois, 80045, United States
  • Alberta Child. Hosp, Calg, CAN accepting new patients
    Calgary, Alberta, T3B 6A9, Canada
  • University of Alberta accepting new patients
    Edmonton, Alberta, T6G 1W9, Canada
  • Baylor College of Medicine/Texas Children's Hospital not yet accepting patients
    Houston, Texas, 77030-2608, United States
  • Monroe-Carell Jr. Children's H not yet accepting patients
    Nashville, Tennessee, 37232, United States
  • Child Hosp of Pittsburgh,PA accepting new patients
    Pittsburgh, Pennsylvania, 15213-2583, United States
  • The Hospital for Sick Children accepting new patients
    Toronto, Ontario, M5G 1X8, Canada
  • UF Hepatology Research at CTRB accepting new patients
    Gainesville, Florida, 32610-0272, United States
  • UNC Health Care accepting new patients
    Chapel Hill, North Carolina, 27514, United States
  • Florida Hospital not yet accepting patients
    Orlando, Florida, 32803, United States
  • University of Pennsylvania not yet accepting patients
    Philadelphia, Pennsylvania, 19104, United States
  • Columbia Univ Medical Center accepting new patients
    New York, New York, 10032, United States
  • Boston Childrens Hospital accepting new patients
    Boston, Massachusetts, 02115, United States
  • Boston Medical Center not yet accepting patients
    Boston, Massachusetts, 02118, United States
  • San Jorge Children Hospital accepting new patients
    San Juan, 00912-3310, Puerto Rico
  • Moscow City Polyclinic Number not yet accepting patients
    Moscow, 119121, Russian Federation
  • Moscow City Polyclinic Number accepting new patients
    Moscow, 119121, Russian Federation
  • Scientific and Research Instit not yet accepting patients
    Saint-petersburg, 197022, Russian Federation
  • Birmingham Childrens Hospital accepting new patients
    Birmingham, B4 6NH, United Kingdom
  • Queen Elizabeth University Hos accepting new patients
    Glasgow, G514TF, United Kingdom
  • King's College Hospital NHS not yet accepting patients
    London, SE5 9RS, United Kingdom
  • Kurume University Hospital accepting new patients
    久留米市, Fukuoka, 〒830-0011, Japan
  • Osaka University Hospital accepting new patients
    Suita, 565-0871, Japan
  • Cliniques Univ. Saint Luc accepting new patients
    Brussels, 1200, Belgium
  • UZ Leuven not yet accepting patients
    Leuven, 3000, Belgium
  • Universitatsklinikum Freiburg accepting new patients
    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
  • Charité Universitätsmedizin Campus Mitte accepting new patients
    Berlin, 10117, Germany
  • Helios Klinikum Wuppertal accepting new patients
    Wuppertal, 42283, Germany
  • Hospital Univ Vall d'Hebron accepting new patients
    Barcelona, 08035, Spain
  • Hospital Sant Joan de Deu accepting new patients
    Esplugues de Llobregat, 08950, Spain
  • Hospital Universitario La Paz accepting new patients
    Madrid, 28046, Spain
  • Hosp Univ Politecnico la Fe not yet accepting patients
    Valencia, 46026, Spain

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT03067129
Phase
Phase 3
Lead Scientist
Philip Rosenthal
Study Type
Interventional
Last Updated
December 21, 2017
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