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A Study to Evaluate Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus Genotype 1-6 Infection, With APRI (a Predictor of Hepatic Fibrosis) ≤ 1, and Have Never Received HCV Treatment

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ClinicalTrials.gov Identifier: NCT03212521
Recruitment Status : Completed
First Posted : July 11, 2017
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
A study to evaluate the efficacy and safety of glecaprevir(GLE)/pibrentasvir(PIB) in treatment-naïve participants with chronic hepatitis C virus (HCV) genotypes 1-6 infection and with an aspartate aminotransferase to platelet ratio index (APRI) of less than or equal to 1.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus (HCV) Drug: glecaprevir/pibrentasvir Phase 4

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults With Chronic Hepatitis C Virus (HCV) Genotypes 1-6 Infection and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤ 1
Actual Study Start Date : August 7, 2017
Actual Primary Completion Date : August 13, 2018
Actual Study Completion Date : August 13, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GLE/PIB
Glecaprevir (GLE)/pibrentasvir (PIB) (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
Drug: glecaprevir/pibrentasvir
Tablet; ABT-493 coformulated with ABT-530
Other Name: Glecaprevir also known as ABT-493 Pibrentasvir also known as ABT-530




Primary Outcome Measures :
  1. Percentage of Participants in the mITT Population With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks after the last actual dose of study drug ]
    SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ) 12 weeks after the last dose of study drug (modified intent-to-treat [mITT] population).


Secondary Outcome Measures :
  1. Percentage of Participants in the ITT Population With SVR12 [ Time Frame: 12 weeks after the last actual dose of study drug ]
    SVR12 was defined as HCV RNA level less than LLOQ 12 weeks after the last dose of study drug (intent-to-treat [ITT] population).

  2. Percentage of Participants With On-treatment Virologic Failure [ Time Frame: Up to approximately 8 weeks ]
    On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment.

  3. Percentage of Participants With Post-treatment Relapse [ Time Frame: From the end of treatment through 12 weeks after the last dose of study drug ]
    Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Screening laboratory result indicating Hepatitis C Virus (HCV) Genotype (GT) 1, 2, 3, 4, 5 or 6 infection. Mixed GT and indeterminate GT may be acceptable.
  • A negative hepatitis B surface antigen (HBsAg), and negative anti-hepatitis B core (HBc) or; hepatitis B virus (HBV) deoxyribonucleic acid (DNA) less than the lower limit of quantification (LLOQ) in participants with isolated positive anti-HBc. (For sites participating in Bulgaria, France, Germany, Poland, Russia, Spain, and UK)
  • Does not have current active HBV infection defined as positive HBsAg or HBV DNA greater than or equal to LLOQ in subjects with isolated positive anti-HBc (i.e negative HBsAg and anti-HBs. (For sites in United States, Puerto Rico, and Canada)
  • Positive plasma HCV antibody and HCV ribonucleic acid (RNA) viral load greater than or equal to 1000 IU/mL at Screening.
  • Aspartate aminotransferase to Platelet Ratio Index (APRI) score of less than or equal to 1, at time of screening.
  • Treatment-naive to any approved or investigational anti-HCV medication.

Exclusion Criteria:

  • Female participant who is pregnant, breastfeeding or is considering becoming pregnant during the study, or for approximately 30 days after the last dose of study drug.
  • Any current or historical clinical evidence of decompensated cirrhosis.
  • History of hepatocellular carcinoma (HCC).

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): NCT03212521


  Show 42 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03212521     History of Changes
Other Study ID Numbers: M16-133
2016-004876-23 ( EudraCT Number )
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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

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 (HCV)
Hepatitis
HCV genotype
aspartate aminotransferase
platelet
Aspartate aminotransferase to Platelet Ratio Index (APRI)
glecaprevir
pibrentasvir
Sustained Virologic Response 12 weeks post dosing (SVR12)

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
N-Methylaspartate
Excitatory Amino Acid Agonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs