Protocol Summary

Protocol No.: OCR16396

Sponsor Protocol No.: AbbVie M16-123

Protocol Title.: 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

Principal Investigator: Jolley, Christopher

Objective: 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.

Phase: Phase III

Age Group: Children

Age: 3 Years - 17 Years

Gender: All

Scope: National

Treatment:

Experimental: Cohort 1: Adult formulation GLE/PIB subjects 12 to < 18yrs
Cohort 1: Adult formulation Glecaprevir (GLE)/Pibrentasvir (PIB) 300 mg/120 mg once daily (QD) for 8, 12, or 16 weeks depending on their hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age.

Experimental: Cohort 4: Pediatric formulation GLE/PIB subjects 3 to < 6yrs
Cohort 4: Pediatric formulation GLE/PIB for 8, 12, or 16 weeks depending on their HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age. Formulation details on GLE/PIB to be provided as part of a study protocol amendment.

Experimental: Cohort 3: Pediatric formulation GLE/PIB subjects 6 to < 9yrs
Cohort 3: Pediatric formulation GLE/PIB for 8, 12, or 16 weeks depending on their HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age. Formulation details on GLE/PIB to be provided as part of a study protocol amendment.

Experimental: Cohort 2: Pediatric formulation GLE/PIB subjects 9 to < 12yrs
Cohort 2: Pediatric formulation GLE/PIB for 8, 12, or 16 weeks depending on their HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age. Formulation details on GLE/PIB to be provided as part of a study protocol amendment.

Detailed Eligibility:

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.

Applicable Conditions:

  • Hepatitis C
  • Participation Institution:

  • UF Gainesville : Patrick Horne
  • Contact:
    Patrick Horne
    Phone: +1 352-273-9464
    Email: patrick.horne@medicine.ufl.edu

    More Information: View study listing on ClinicialTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT03067129