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

  • University of California San Francisco /ID# 158002 accepting new patients
    San Francisco, California, 94158, United States
  • Childrens Hospital Colorado /ID# 157996 accepting new patients
    Aurora, Colorado, 80045-7106, United States
  • Alberta Children's Hospital, Calgary, Canada /ID# 163449 not yet accepting patients
    Calgary, T3B 6A8, Canada
  • University of Alberta /ID# 163450 not yet accepting patients
    Edmonton, T6G 1C9, Canada
  • Unity Point Health - Des Moines /ID# 167164 withdrawn
    Des Moines, Iowa, 50309, United States
  • Texas Children's Hospital /ID# 157989 accepting new patients
    Houston, Texas, 77030, United States
  • Children's Hospital of Pittsburgh, Pennsylvania /ID# 158004 accepting new patients
    Pittsburgh, Pennsylvania, 15224, United States
  • The Hospital for Sick Children (SickKids) /ID# 163448 not yet accepting patients
    Toronto, M5G 1X8, Canada
  • UF Hepatology Research at CTRB /ID# 158008 accepting new patients
    Gainesville, Florida, 32610-0272, United States
  • UNC School of Medicine /ID# 157991 accepting new patients
    Chapel Hill, North Carolina, 27599, United States
  • Florida Hospital /ID# 166022 not yet accepting patients
    Orlando, Florida, 32803, United States
  • The Children's Hospital of Philadelphia (CHOP) /ID# 158003 not yet accepting patients
    Philadelphia, Pennsylvania, 19104, United States
  • Columbia University /ID# 158000 accepting new patients
    New York, New York, 10032, United States
  • Boston Childrens Hospital /ID# 157988 accepting new patients
    Boston, Massachusetts, 02115, United States
  • Boston Medical Center /ID# 157997 accepting new patients
    Boston, Massachusetts, 02118, United States
  • San Jorge Children Hospital /ID# 160850 accepting new patients
    San Juan, 00912, Puerto Rico
  • Birmingham Childrens Hospital /ID# 162718 not yet accepting patients
    Birmingham, B46NH, United Kingdom
  • Queen Elizabeth University Hospital /ID# 162719 not yet accepting patients
    Glasgow, G514TF, United Kingdom
  • Kings College London NHS Foundation Trust /ID# 162717 not yet accepting patients
    London, SE5 9RS, United Kingdom
  • Kurume University Hospital /ID# 165718 accepting new patients
    Kurume-shi,Fukuoka, Japan
  • Osaka University Hospital /ID# 165709 not yet accepting patients
    Suita-shi, Osaka, Japan
  • Cliniques Universitaires Saint-Luc /ID# 162173 not yet accepting patients
    Brussels, 1200, Belgium
  • Universitair Ziekenhuis Leuven /ID# 162174 not yet accepting patients
    Leuven, 3000, Belgium
  • Charite Universitaetsmedizin Berlin /ID# 165186 not yet accepting patients
    Berlin, 13353, Germany
  • Universitatsklinikum Freiburg /ID# 165187 not yet accepting patients
    Freiburg, 79106, Germany
  • Helios Klinikum Wuppertal /ID# 165185 not yet accepting patients
    Wuppertal, 42283, Germany
  • Hospital Universitario Vall d'Hebron /ID# 163323 not yet accepting patients
    Barcelona, 8035, Spain
  • Hospital Universitario La Paz /ID# 163283 accepting new patients
    Madrid, 28046, 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
October 31, 2017
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