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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

This study is currently recruiting participants.
Verified October 2017 by AbbVie
Sponsor:
ClinicalTrials.gov Identifier:
NCT03067129
First Posted: March 1, 2017
Last Update Posted: November 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
AbbVie
  Purpose

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 Intervention Phase
Hepatitis C Virus (HCV) Drug: Glecaprevir/Pibrentasvir Phase 3

Access to an investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 110
Actual Study Start Date: March 20, 2017
Estimated Study Completion Date: April 27, 2022
Estimated Primary Completion Date: September 19, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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
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 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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03067129     History of Changes
Other Study ID Numbers: M16-123
2016-004102-34 ( EudraCT Number )
First Submitted: February 24, 2017
First Posted: March 1, 2017
Last Update Posted: November 2, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AbbVie:
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

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