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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 : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief 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.


Condition or disease Intervention/treatment Phase
Hepatitis C Virus (HCV) Drug: Glecaprevir/Pibrentasvir Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 20, 2017
Estimated Primary Completion Date : September 19, 2019
Estimated Study Completion Date : May 26, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/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.
Drug: Glecaprevir/Pibrentasvir
Film-coated tablet (100 mg/40 mg)
Other Name: ABT-493/ABT-530

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.
Drug: Glecaprevir/Pibrentasvir
Oral pediatric formulation
Other Name: ABT-493/ABT-530

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.
Drug: Glecaprevir/Pibrentasvir
Oral pediatric formulation
Other Name: ABT-493/ABT-530

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.
Drug: Glecaprevir/Pibrentasvir
Oral pediatric formulation
Other Name: ABT-493/ABT-530




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Clearance of GLE [ Time Frame: Up to 16 weeks ]
    Clearance is defined the volume of plasma cleared of the drug per unit time.

  4. 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.

  5. Maximum observed plasma concentration (Cmax) of PIB [ Time Frame: Up to 16 weeks ]
    Maximum observed plasma concentration (Cmax) of PIB after administration.

  6. Clearance of PIB [ Time Frame: Up to 16 weeks ]
    Clearance is defined the volume of plasma cleared of the drug per unit time.

  7. 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.

  8. Maximum observed plasma concentration (Cmax) of GLE [ Time Frame: Up to 16 weeks ]
    Maximum observed plasma concentration (Cmax) of GLE after administration.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03067129


Contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

  Hide Study Locations
Locations
United States, California
Univ of California San Francis Recruiting
San Francisco, California, United States, 94158
United States, Colorado
Childrens Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
United States, Connecticut
CT Childrens Medical Ctr, US Not yet recruiting
Hartford, Connecticut, United States, 06106
United States, Florida
UF Hepatology Research at CTRB Recruiting
Gainesville, Florida, United States, 32610-0272
Florida Hospital Not yet recruiting
Orlando, Florida, United States, 32803
United States, Indiana
Indiana University Not yet recruiting
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Boston Childrens Hospital Recruiting
Boston, Massachusetts, United States, 02115
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
United States, New York
Columbia Univ Medical Center Recruiting
New York, New York, United States, 10032-3725
United States, North Carolina
UNC Health Care Recruiting
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Cincinnati Childrens Hosp Med Not yet recruiting
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-5502
Child Hosp of Pittsburgh,PA Recruiting
Pittsburgh, Pennsylvania, United States, 15213-2583
United States, Tennessee
Monroe-Carell Jr. Children's H Not yet recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030-2608
Belgium
Cliniques Universitaires Saint Luc Recruiting
Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
UZ Leuven Not yet recruiting
Leuven, Belgium, 3000
Canada, Alberta
Alberta Child. Hosp, Calg, CAN Recruiting
Calgary, Alberta, Canada, T3B 6A9
Zeidler Ledcor Centre Recruiting
Edmonton, Alberta, Canada, T6G 2X8
Canada, British Columbia
BC Children's Hospital and Res Not yet recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Ontario
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Germany
Universitatsklinikum Freiburg Recruiting
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
Charité Universitätsmedizin Campus Mitte Recruiting
Berlin, Germany, 10117
Helios Klinikum Wuppertal Recruiting
Wuppertal, Germany, 42283
Japan
Kurume University Hospital Recruiting
Kurume-shi, Fukuoka, Japan, 830-0011
Osaka University Hospital Recruiting
Suita-shi, Osaka, Japan, 565-0871
Puerto Rico
San Jorge Children Hospital Recruiting
San Juan, Puerto Rico, 00912-3310
Russian Federation
Federal State Budgetary Institution "Scientific Center of Hematology" Ministry o Not yet recruiting
Moscow, Moskva, Russian Federation, 125167
Federal State Budgetary Institution "Scientific Center of Hematology" Ministry o Recruiting
Moscow, Moskva, Russian Federation, 125167
Scientific and Research Instit Not yet recruiting
Saint-petersburg, Russian Federation, 197022
Spain
Hospital Univ Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Hospital Sant Joan de Deu Recruiting
Esplugues de Llobregat, Spain, 08950
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Hosp Univ Politecnico la Fe Not yet recruiting
Valencia, Spain, 46026
United Kingdom
Birmingham Childrens Hospital Recruiting
Birmingham, United Kingdom, B4 6NH
Queen Elizabeth University Hos Recruiting
Glasgow, United Kingdom, G514TF
King's College Hospital NHS Not yet recruiting
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03067129     History of Changes
Other Study ID Numbers: M16-123
2016-004102-34 ( EudraCT Number )
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by AbbVie:
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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents