Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study

Part of paid clinical trials in Dothan, Alabama.

Sponsor
AbbVie
Study ID
NCT02939989
Phase
PHASE3
Status
Completed

Conditions

  • Hepatitis C Virus Infection

Eligibility Criteria

Sex
ALL
Age
12 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Sofosbuvir — DRUG
    Tablet for oral administration
  • Glecaprevir/Pibrentasvir — DRUG
    Coformulated tablet for oral administration
  • Ribavirin — DRUG
    Tablet for oral administration

Study Details

The purpose of this study was to evaluate the efficacy and safety of co-administration of glecaprevir (ABT-493)/pibrentasvir (ABT 530) plus sofosbuvir (SOF) plus ribavirin (RBV) in hepatitis C virus (HCV) genotype (GT) 1 - 6-infected participants (including non-cirrhotic, or cirrhotic with compensated cirrhosis participants) who had experienced virologic failure in an AbbVie parent clinical study.

Key Dates

Start date
Nov 21, 2016
Status verified
Apr 2022
Primary completion
May 7, 2021
Completion
Jul 30, 2021

Study Design

Enrollment
33 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Glecaprevir/Pibrentasvir + SOF + RBV for 12 weeks
    Participants without cirrhosis who had non-genotype 3 infection and were naïve to protease inhibitor (PI) and/or nonstructural viral protein 5A inhibitor (NS5Ai) prior to participation in AbbVie HCV parent study received daily treatment with glecaprevir/pibrentasvir (GLE/PIB) 300 mg/120 mg plus sofosbuvir (SOF) 400 mg plus twice-daily weight-based ribavirin (RBV) 600 mg - 1200 mg daily total for 12 weeks.
  • Experimental: Glecaprevir/Pibrentasvir + SOF + RBV for 16 weeks
    Participants with genotype 3, and/or compensated cirrhosis, and/or experience with PI and/or NS5Ai prior to participation in Abbvie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 16 weeks.

Primary Outcome Measure

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen. ]

Locations (8)

FacilityCityStateZIPSite coordinators
Digestive Health Specialists of the Southeast /ID# 155719DothanAlabama36305-
Ruane Clinical Research Group /ID# 155714Los AngelesCalifornia90036-
Digestive Disease Associates - Baltimore /ID# 155713BaltimoreMaryland21229-
Henry Ford Health System /ID# 155720DetroitMichigan48202-
University of Buffalo /ID# 155721BuffaloNew York14203-
Carolinas Center For Liver Dis /ID# 155731StatesvilleNorth Carolina28677-
Gastro One /ID# 155729GermantownTennessee38138-
TX Liver Inst, Americ Res Corp /ID# 157881San AntonioTexas78215-

Find similar trials in Dothan, AL

By research site
Digestive Health Specialists of the Southeast· Dothan, ALRuane Clinical Research Group· Los Angeles, CADigestive Disease Associates - Baltimore· Baltimore, MDHenry Ford Health System· Detroit, MIUniversity of Buffalo· Buffalo, NYCarolinas Center For Liver Dis· Statesville, NC

Related Studies