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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 (DORA)

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ClinicalTrials.gov Identifier: NCT03067129
Recruitment Status : Recruiting
First Posted : March 1, 2017
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

February 24, 2017
March 1, 2017
September 25, 2018
March 20, 2017
September 19, 2019   (Final data collection date for primary outcome measure)
  • Area under the curve (AUC) of Glecaprevir (GLE) [ Time Frame: Up to 16 weeks ]
    The area under the plasma concentration-time curve (AUC) is a method of measurement of the total exposure of a drug in blood plasma.
  • AUC of Pibrentasvir (PIB) [ Time Frame: Up to 16 weeks ]
    The area under the plasma concentration-time curve (AUC) is a method of measurement of the total exposure of a drug in blood plasma.
Same as current
Complete list of historical versions of study NCT03067129 on ClinicalTrials.gov Archive Site
  • Percentage of participants who with post-treatment HCV virologic relapse [ Time Frame: Up to 160 weeks after first dose of study drug ]
    Post-treatment relapse is defined as confirmed HCV RNA greater than or equal to the LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA less than LLOQ at the end of treatment; excluding participants who have been shown to be re-infected.
  • Percentage of participants with new HCV infection at any time up to the last study visit [ Time Frame: Up to 160 weeks after first dose of study drug ]
    Participants with new HCV infection at any time up to the last study visit.
  • Clearance of GLE [ Time Frame: Up to 16 weeks ]
    Clearance is defined the volume of plasma cleared of the drug per unit time.
  • Percentage of participants who experience on-treatment virologic failure (i.e., breakthrough or fail to suppress at the end of treatment) [ Time Frame: Up to 160 weeks after first dose of study drug ]
    Virologic failure defined as confirmed increase of greater than 1 log10 IU/mL above nadir during treatment, confirmed HCV RNA greater than or equal to 100 IU/mL after HCV RNA less than LLOQ during treatment, or HCV RNA greater than or equal to LLOQ at the end of treatment with at least 6 weeks of treatment.
  • Maximum observed plasma concentration (Cmax) of PIB [ Time Frame: Up to 16 weeks ]
    Maximum observed plasma concentration (Cmax) of PIB after administration.
  • Clearance of PIB [ Time Frame: Up to 16 weeks ]
    Clearance is defined the volume of plasma cleared of the drug per unit time.
  • Percentage of participants with sustained virologic response 12 weeks post dosing (SVR12) [ Time Frame: 12 weeks after last dose of study drug ]
    SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than the lower limit of quantitation (LLOQ) (less than 15 IU/mL) 12 weeks after the last actual dose of study drug.
  • Maximum observed plasma concentration (Cmax) of GLE [ Time Frame: Up to 16 weeks ]
    Maximum observed plasma concentration (Cmax) of GLE after administration.
  • Maximum observed plasma concentration (Cmax) of GLE [ Time Frame: Up to 16 weeks ]
    Maximum observed plasma concentration (Cmax) of GLE after administration.
  • Maximum observed plasma concentration (Cmax) of PIB [ Time Frame: Up to 16 weeks ]
    Maximum observed plasma concentration (Cmax) of PIB after administration.
  • Clearance of GLE [ Time Frame: Up to 16 weeks ]
    Clearance is defined the volume of plasma cleared of the drug per unit time.
  • Clearance of PIB [ Time Frame: Up to 16 weeks ]
    Clearance is defined the volume of plasma cleared of the drug per unit time.
  • Percentage of participants with sustained virologic response 12 weeks post dosing (SVR12) [ Time Frame: 12 weeks after last dose of study drug ]
    SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than the lower limit of quantitation (LLOQ) (less than 15 IU/mL) 12 weeks after the last actual dose of study drug.
  • Percentage of participants who with post-treatment HCV virologic relapse [ Time Frame: Up to 160 weeks after first dose of study drug ]
    Post-treatment relapse is defined as confirmed HCV RNA greater than or equal to the LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA less than LLOQ at the end of treatment; excluding participants who have been shown to be re-infected.
  • Percentage of participants who experience on-treatment virologic failure (i.e., breakthrough or fail to suppress) [ Time Frame: Up to 160 weeks after first dose of study drug ]
    Virologic failure defined as confirmed increase of greater than 1 log10 IU/mL above nadir during treatment, confirmed HCV RNA greater than or equal to 100 IU/mL after HCV RNA less than LLOQ during treatment, or HCV RNA greater than or equal to LLOQ at the end of treatment with at least 6 weeks of treatment.
  • Percentage of participants with new HCV infection at any time up to the last study visit [ Time Frame: Up to 160 weeks after first dose of study drug ]
    Participants with new HCV infection at any time up to the last study visit.
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hepatitis C Virus (HCV)
  • Drug: Glecaprevir/Pibrentasvir
    Film-coated tablet (100 mg/40 mg)
    Other Name: ABT-493/ABT-530
  • Drug: Glecaprevir/Pibrentasvir
    Oral pediatric formulation
    Other Name: ABT-493/ABT-530
  • 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.
    Intervention: Drug: Glecaprevir/Pibrentasvir
  • 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.
    Intervention: Drug: Glecaprevir/Pibrentasvir
  • 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.
    Intervention: Drug: Glecaprevir/Pibrentasvir
  • 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.
    Intervention: Drug: Glecaprevir/Pibrentasvir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
100
May 26, 2022
September 19, 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
3 Years to 17 Years   (Child)
No
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com
Belgium,   Canada,   Germany,   Japan,   Puerto Rico,   Russian Federation,   Spain,   United Kingdom,   United States
 
 
NCT03067129
M16-123
2016-004102-34 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
AbbVie
AbbVie
Not Provided
Study Director: AbbVie Inc. AbbVie
AbbVie
September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP