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

NCT ID: NCT02441283

Last Updated: 2020-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 384 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-22
• Study Completion Date: 2019-10-15

Brief Summary

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.

Detailed Description

This was a Phase 2/3, multicenter study offered to participants who received at least one dose of an ABT-493- and/or ABT-530-containing regimen at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV and elected to enroll in this study. The participant must have completed the follow-up period of the prior eligible AbbVie study. Participants were followed for a total of approximately 3 years after their last dose of DAA in the previous HCV clinical study. The 3 years were inclusive of any post-treatment period in the prior study, as well as any gaps between the end of the prior study and enrollment in this study.

Conditions

Hepatitis C

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

HCV-infected Participants

Hepatitis C virus (HCV)-infected participants who received ABT-493 and/or ABT-530 in prior Phase 2 or 3 clinical studies with these agents for the treatment of chronic HCV and were not retreated prior to entering this study. No AbbVie study drug was administered in this study.

Group Type: NO_INTERVENTION

ABT-493

Intervention Type: DRUG

ABT-493 was not administered in this study. This study was a follow-up for participants who received the drug in prior studies.

ABT-530

Intervention Type: DRUG

ABT-530 was not administered in this study. This study was a follow-up for participants who received the drug in prior studies.

Interventions

ABT-493

ABT-493 was not administered in this study. This study was a follow-up for participants who received the drug in prior studies.

Intervention Type: DRUG

ABT-530

ABT-530 was not administered in this study. This study was a follow-up for participants who received the drug in prior studies.

Intervention Type: DRUG

Other Intervention Names

Glecaprevir; Pibrentasvir

Eligibility Criteria

Inclusion Criteria

1. Participant is male or female 18 years of age or older

2. 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

3. 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.

4. 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.

5. Participant completed the post-treatment period of an eligible prior study.

Exclusion Criteria

1. 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).

2. Receipt of any investigational HCV antiviral treatment after receiving ABT-493 and/or ABT-530 in the prior study.

3. Participants who experienced non-virologic treatment failure due to premature discontinuation of study drug in prior study of ABT-493/ABT-530.

4. Participation in AbbVie's Study M15-942 protocol for re-treatment for virologic failure in the prior Phase 2 or 3 study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

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

Royal Melbourne Hospital /ID# 155393

Parkville, Victoria, Australia

Cliniques Universitaires Saint Luc /ID# 155397

Woluwe-Saint-Lambert, Brussels Capital, Belgium

CHU St. Pierre /ID# 155399

Brussels, , Belgium

UZ Leuven /ID# 155398

Leuven, , Belgium

University of Calgary /ID# 155400

Calgary, Alberta, Canada

Toronto Liver Centre /ID# 155401

Toronto, Ontario, Canada

Universitätsklinikum Frankfurt /ID# 169817

Frankfurt am Main, Hesse, Germany

Mauss, Schmutz, Hegener, Athma /ID# 155402

Düsseldorf, , Germany

Gastroenterologisch-Hepatologi /ID# 169820

Kiel, , Germany

Auckland City Hospital /ID# 155403

Auckland, , New Zealand

Gastro-Hepato & Geriatric Ctr /ID# 141060

Ponce, , Puerto Rico

Klinical Investigations Group /ID# 141059

San Juan, , Puerto Rico

Innovative Care P.S.C. /ID# 141061

San Juan, , Puerto Rico

The Royal London Hospital /ID# 155405

London, London, City of, United Kingdom

King's College Hospital NHS /ID# 155406

London, , United Kingdom

St. Mary's Hospital /ID# 155404

London, , United Kingdom

Derriford Hospital /ID# 155407

Plymouth, , United Kingdom

Countries

United States; Australia; Belgium; Canada; Germany; New Zealand; Puerto Rico; United Kingdom

References

Poordad F, Felizarta F, Yao BB, Overcash JS, Hassanein T, Agarwal K, Gane E, Shaw D, Waters M, Krishnan P, Topp A, Burroughs M, Nevens F. Durability of sustained virological response to glecaprevir/pibrentasvir and resistance development: A long-term follow-up study. Liver Int. 2022 Jun;42(6):1278-1286. doi: 10.1111/liv.15211. Epub 2022 Mar 14.

Reference Type: DERIVED

PMID: 35220658 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2015-000452-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M13-576

Identifier Type: -

Identifier Source: org_study_id