DORA

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

Brief summary

An open-label study to assess the pharmacokinetics (PK), safety, and efficacy of an active drug 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 the active drug. 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 the active drug. All participants will receive the active drug for 8, 12, or 16 weeks depending on their hepatitis C virus (HCV) genotype, cirrhosis, and prior treatment experience status.

Interventional study

Status:
Completed
Conditions:
Hepatitis C Virus (HCV)
Enrollment:
127 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M16-123
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Masking:
None (Open Label)
Purpose:
Treatment

 

Eligibility criteria

Participant attributes:
Male and Female

Age:

From 3 Years to 17 Years.

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

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-Pugh class B or C cirrhosis

All the cities where the clinical studies are located

Calgary - T3B 6A9
Edmonton - T6G 2X8
Toronto - M5G 1X8

Ontario

More information about this study

clinicaltrials.gov