A Study to Assess Resistance and Durability of Response to ABT-493 and/or ABT-530
A Follow-up Study to Assess Resistance and Durability of Response to AbbVie Direct-Acting Antiviral Agent (DAA) Therapy (ABT-493 and/or ABT-530) in Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection
2 other identifiers
interventional
384
8 countries
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2015
Typical duration for phase_2
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2015
CompletedFirst Posted
Study publicly available on registry
May 12, 2015
CompletedStudy Start
First participant enrolled
June 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2019
CompletedResults Posted
Study results publicly available
September 21, 2020
CompletedSeptember 21, 2020
August 1, 2020
4.3 years
April 29, 2015
August 31, 2020
August 31, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of Participants Who Maintained a Sustained Virologic Response (SVR) Out of Those Who Achieved SVR12 in a Prior Study With an ABT-493- and/or ABT-530-containing Regimen
Maintaining a sustained virologic response (SVR) is defined as having Hepatitis C virus ribonucleic acid (HCV RNA) value consistently below the lower limit of quantification (\< LLOQ) from the end of treatment in the previous study throughout Study M13-576 (this study).
From the end of treatment in the previous study up to 3 years post-treatment
Percentage of Participants Who Relapsed or Had a New Hepatitis C Virus (HCV) Infection at Any Time up to the Last Follow-up in This Study Among Participants Who Achieved SVR12 in a Prior Study With an ABT-493- and/or ABT-530-containing Regimen
Relapse was defined as confirmed Hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (≥ LLOQ) between end of treatment and up to and including the last HCV RNA measurement collected in this study for a participant with HCV RNA \< LLOQ at Final Treatment Visit who completed treatment, excluding reinfection. HCV reinfection was defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA \< LLOQ at Final Treatment Visit, along with the post-treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences.
From the end of treatment in the previous study up to 3 years post-treatment
Number of Participants With Persistence of Resistance-Associated Amino Acid Variants Among Those Experiencing Virologic Failure
Plasma samples for HCV resistance testing were collected at study visits. The variants in nonstructural viral protein 3 (NS3) and nonstructural viral protein 5A (NS5A) at amino acid positions of interest were analyzed by next generation sequencing relative to baseline and prototypic reference sequences.
From Day 1 to Month 12
Secondary Outcomes (5)
Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection
After Day 1 up to 3 years post-treatment
Mean Concentration of Interferon Gamma-induced Protein 10 (IP-10) Over Time
From Day 1 up to 3 years post-treatment
Mean FibroTest Score Over Time
From Day 1 up to 3 years post-treatment
Mean Aspartate Transaminase to Platelet Ratio Index (APRI) Over Time
From Day 1 up to 3 years post-treatment
Mean FibroScan Scores Over Time
Up to 3 years post-treatment
Study Arms (1)
HCV-infected Participants
NO INTERVENTIONHepatitis 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.
Interventions
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 was not administered in this study. This study was a follow-up for participants who received the drug in prior studies.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (42)
Digestive Health Specialists of the Southeast /ID# 136725
Dothan, Alabama, 36305, United States
Felizarta /ID# 141033
Bakersfield, California, 93301, United States
Southern California Res. Ctr. /ID# 141799
Coronado, California, 92118-1408, United States
Research & Education, Inc. /ID# 169591
San Diego, California, 92105, United States
eStudySite San Diego /ID# 141040
San Diego, California, 92120, United States
eStudySite San Diego /ID# 141047
San Diego, California, 92120, United States
eStudySite San Diego /ID# 141048
San Diego, California, 92120, United States
Midway Immunology and Research /ID# 169477
Ft. Pierce, Florida, 34982, United States
Delta Research Partners /ID# 141028
Bastrop, Louisiana, 71220, United States
Louisiana Research Ctr. LLC /ID# 141024
Shreveport, Louisiana, 71105-6800, United States
Henry Ford Health System /ID# 141039
Detroit, Michigan, 48202, United States
Binghamton Gastroenterology /ID# 141026
Binghamton, New York, 13903, United States
Carolinas Center for Liver Dis /ID# 155390
Statesville, North Carolina, 28677-3471, United States
Northwest Gastroenterology Cli /ID# 141036
Portland, Oregon, 97210, United States
Gastro One /ID# 169478
Germantown, Tennessee, 38138, United States
Quality Medical Research, PLLC /ID# 141042
Nashville, Tennessee, 37211, United States
TX Clinical Research Institute /ID# 141037
Arlington, Texas, 76012, United States
Inquest Clinical Research /ID# 141045
Baytown, Texas, 77521-2415, United States
TX Liver Inst, Americ Res Corp /ID# 136727
San Antonio, Texas, 78215, United States
Bon Secours St. Mary's Hospita /ID# 165106
Richmond, Virginia, 23226, United States
St. Vincent's Hospital, Darlinghurst /ID# 155395
Darlinghurst, New South Wales, 2010, Australia
St. Vincents Hospital /ID# 155394
East Lismore, New South Wales, 2480, Australia
Westmead Hospital /ID# 155392
Westmead, New South Wales, 2145, Australia
Royal Brisbane and Women's Hospital /ID# 155396
Herston, Queensland, 4029, Australia
Royal Adelaide Hospital /ID# 155391
Adelaide, South Australia, 5000, Australia
Royal Melbourne Hospital /ID# 155393
Parkville, Victoria, 3050, Australia
Cliniques Universitaires Saint Luc /ID# 155397
Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium
CHU St. Pierre /ID# 155399
Brussels, 1000, Belgium
UZ Leuven /ID# 155398
Leuven, 3000, Belgium
University of Calgary /ID# 155400
Calgary, Alberta, T2N 4Z6, Canada
Toronto Liver Centre /ID# 155401
Toronto, Ontario, M6H 3M1, Canada
Universitätsklinikum Frankfurt /ID# 169817
Frankfurt am Main, Hesse, 60590, Germany
Mauss, Schmutz, Hegener, Athma /ID# 155402
Düsseldorf, 40237, Germany
Gastroenterologisch-Hepatologi /ID# 169820
Kiel, 24146, Germany
Auckland City Hospital /ID# 155403
Auckland, 1023, New Zealand
Gastro-Hepato & Geriatric Ctr /ID# 141060
Ponce, 00716, Puerto Rico
Klinical Investigations Group /ID# 141059
San Juan, 00909, Puerto Rico
Innovative Care P.S.C. /ID# 141061
San Juan, 00959, Puerto Rico
The Royal London Hospital /ID# 155405
London, London, City of, E1 1BB, United Kingdom
King's College Hospital NHS /ID# 155406
London, SE5 9RS, United Kingdom
St. Mary's Hospital /ID# 155404
London, W2 1NY, United Kingdom
Derriford Hospital /ID# 155407
Plymouth, PL6 8DH, United Kingdom
Related Publications (1)
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.
PMID: 35220658DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
April 29, 2015
First Posted
May 12, 2015
Study Start
June 22, 2015
Primary Completion
October 15, 2019
Study Completion
October 15, 2019
Last Updated
September 21, 2020
Results First Posted
September 21, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
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.