A Study to Assess Resistance and Durability of Response to ABT-493 and/or ABT-530

Completed · Phase 2/Phase 3

Conditions studied: Hepatitis C

In brief

This was a long-term follow-up study to evaluate the durability of sustained virologic response (SVR), persistence of direct-acting antiviral agent (DAA) resistance, and clinical outcomes for participants who received glecaprevir (ABT-493) and/or pibrentasvir (ABT-530) in prior AbbVie Phase 2 or 3 clinical studies for the treatment of chronic hepatitis C virus (HCV) infection.

Key facts

Study ID

NCT02441283

Run by

AbbVie

People needed

384

Starts

2015-06-22

Expected to finish

2019-10-15

Last updated by the study team

2020-09-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant is male or female 18 years of age or older
• Participant has received at least one dose of an ABT-493- and/or ABT- 530 containing regimen in a prior AbbVie hepatitis C virus (HCV) Phase 2 or 3 study
• The interval between the last dose of the AbbVie direct-acting antiviral agent (DAA) therapy from the previous clinical study and enrollment in Study M13-576 must be no longer than 2 years for subjects who have not been retreated. Participants who have been treated with a commercially available anti-HCV treatment may be enrolled greater than 2 years after the last dose of the AbbVie DAA therapy from the previous clinical study.
• Participant must voluntarily sign and date the informed consent form approved by an Independent Review Board or Ethics Committee prior to the initiation of any study-specific procedures.
• Participant completed the post-treatment period of an eligible prior study.

You may not qualify if…

• The investigator considers the participant unsuitable for the study for any reasons (e.g., failure to comply with study procedures in the prior AbbVie clinical study).
• Receipt of any investigational HCV antiviral treatment after receiving ABT-493 and/or ABT-530 in the prior study.
• Participants who experienced non-virologic treatment failure due to premature discontinuation of study drug in prior study of ABT-493/ABT-530.
• Participation in AbbVie's Study M15-942 protocol for re-treatment for virologic failure in the prior Phase 2 or 3 study.

Where it is running

• Digestive Health Specialists of the Southeast /ID# 136725 — Dothan, Alabama, United States
• Felizarta /ID# 141033 — Bakersfield, California, United States
• Southern California Res. Ctr. /ID# 141799 — Coronado, California, United States
• Research & Education, Inc. /ID# 169591 — San Diego, California, United States
• eStudySite San Diego /ID# 141040 — San Diego, California, United States
• eStudySite San Diego /ID# 141047 — San Diego, California, United States
• eStudySite San Diego /ID# 141048 — San Diego, California, United States
• Midway Immunology and Research /ID# 169477 — Ft. Pierce, Florida, United States
• Delta Research Partners /ID# 141028 — Bastrop, Louisiana, United States
• Louisiana Research Ctr. LLC /ID# 141024 — Shreveport, Louisiana, United States
• Henry Ford Health System /ID# 141039 — Detroit, Michigan, United States
• Binghamton Gastroenterology /ID# 141026 — Binghamton, New York, United States
• Carolinas Center for Liver Dis /ID# 155390 — Statesville, North Carolina, United States
• Northwest Gastroenterology Cli /ID# 141036 — Portland, Oregon, United States
• Gastro One /ID# 169478 — Germantown, Tennessee, United States
• Quality Medical Research, PLLC /ID# 141042 — Nashville, Tennessee, United States
• TX Clinical Research Institute /ID# 141037 — Arlington, Texas, United States
• Inquest Clinical Research /ID# 141045 — Baytown, Texas, United States
• TX Liver Inst, Americ Res Corp /ID# 136727 — San Antonio, Texas, United States
• Bon Secours St. Mary's Hospita /ID# 165106 — Richmond, Virginia, United States
• St. Vincent's Hospital, Darlinghurst /ID# 155395 — Darlinghurst, New South Wales, Australia
• St. Vincents Hospital /ID# 155394 — East Lismore, New South Wales, Australia
• Westmead Hospital /ID# 155392 — Westmead, New South Wales, Australia
• Royal Brisbane and Women's Hospital /ID# 155396 — Herston, Queensland, Australia
• Royal Adelaide Hospital /ID# 155391 — Adelaide, South Australia, Australia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.