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Hepatitis CPhase 2/3NCT02441283

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

A Phase 2/3 study testing ABT-493 and ABT-530 in people with Hepatitis C, run by AbbVie at 42 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hepatitis C
What is being tested?
ABT-493 and ABT-530
Could I receive a placebo?
No, everyone receives an active treatment
How many people
384 participants
Where
42 sitesin 8 countries
Study dates
22 Jun 2015to 15 Oct 2019
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

42 sites in 8 countries.

42 sites in 8 countries

United States20 sites

  • TX Clinical Research Institute /ID# 141037

    Arlington, Texas, 76012

  • Felizarta /ID# 141033

    Bakersfield, California, 93301

  • Delta Research Partners /ID# 141028

    Bastrop, Louisiana, 71220

  • Inquest Clinical Research /ID# 141045

    Baytown, Texas, 77521-2415

  • Binghamton Gastroenterology /ID# 141026

    Binghamton, New York, 13903

  • Southern California Res. Ctr. /ID# 141799

    Coronado, California, 92118-1408

  • Henry Ford Health System /ID# 141039

    Detroit, Michigan, 48202

  • Digestive Health Specialists of the Southeast /ID# 136725

    Dothan, Alabama, 36305

  • Midway Immunology and Research /ID# 169477

    Ft. Pierce, Florida, 34982

  • Gastro One /ID# 169478

    Germantown, Tennessee, 38138

  • Quality Medical Research, PLLC /ID# 141042

    Nashville, Tennessee, 37211

  • Northwest Gastroenterology Cli /ID# 141036

    Portland, Oregon, 97210

  • Bon Secours St. Mary's Hospita /ID# 165106

    Richmond, Virginia, 23226

  • TX Liver Inst, Americ Res Corp /ID# 136727

    San Antonio, Texas, 78215

  • Research & Education, Inc. /ID# 169591

    San Diego, California, 92105

  • eStudySite San Diego /ID# 141040

    San Diego, California, 92120

  • eStudySite San Diego /ID# 141047

    San Diego, California, 92120

  • eStudySite San Diego /ID# 141048

    San Diego, California, 92120

  • Louisiana Research Ctr. LLC /ID# 141024

    Shreveport, Louisiana, 71105-6800

  • Carolinas Center for Liver Dis /ID# 155390

    Statesville, North Carolina, 28677-3471

Other trials in United States

Australia6 sites

  • Royal Adelaide Hospital /ID# 155391

    Adelaide, South Australia, 5000

  • St. Vincent's Hospital, Darlinghurst /ID# 155395

    Darlinghurst, New South Wales, 2010

  • St. Vincents Hospital /ID# 155394

    East Lismore, New South Wales, 2480

  • Royal Brisbane and Women's Hospital /ID# 155396

    Herston, Queensland, 4029

  • Royal Melbourne Hospital /ID# 155393

    Parkville, Victoria, 3050

  • Westmead Hospital /ID# 155392

    Westmead, New South Wales, 2145

Other trials in Australia

United Kingdom4 sites

  • The Royal London Hospital /ID# 155405

    London, London, City of, E1 1BB

  • King's College Hospital NHS /ID# 155406

    London, SE5 9RS

  • St. Mary's Hospital /ID# 155404

    London, W2 1NY

  • Derriford Hospital /ID# 155407

    Plymouth, PL6 8DH

Other trials in United Kingdom

Belgium3 sites

  • CHU St. Pierre /ID# 155399

    Brussels, 1000

  • UZ Leuven /ID# 155398

    Leuven, 3000

  • Cliniques Universitaires Saint Luc /ID# 155397

    Woluwe-Saint-Lambert, Brussels Capital, 1200

Other trials in Belgium

Germany3 sites

  • Mauss, Schmutz, Hegener, Athma /ID# 155402

    Düsseldorf, 40237

  • Universitätsklinikum Frankfurt /ID# 169817

    Frankfurt am Main, Hesse, 60590

  • Gastroenterologisch-Hepatologi /ID# 169820

    Kiel, 24146

Other trials in Germany

Puerto Rico3 sites

  • Gastro-Hepato & Geriatric Ctr /ID# 141060

    Ponce, 00716

  • Klinical Investigations Group /ID# 141059

    San Juan, 00909

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

    San Juan, 00959

Other trials in Puerto Rico

Canada2 sites

  • University of Calgary /ID# 155400

    Calgary, Alberta, T2N 4Z6

  • Toronto Liver Centre /ID# 155401

    Toronto, Ontario, M6H 3M1

Other trials in Canada

New Zealand1 site

  • Auckland City Hospital /ID# 155403

    Auckland, 1023

Other trials in New Zealand

About this study

Official title: 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

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.

Read the 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
Being tested
ABT-493, ABT-530
Keywords
Chronic hepatitis C, Hepatitis C virus, Sustained virologic response, Hepatitis C, Direct Acting Antiviral
Medical subject headings
Hepatitis C, Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABT-493Drug

    Also called Glecaprevir

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

  • ABT-530Drug

    Also called Pibrentasvir

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

Study groups in NCT02441283
Study groupRoleWhat they receive
HCV-infected ParticipantsNo 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.
Receives: Drug: ABT-493; Drug: ABT-530

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: From the end of treatment in the previous study up to 3 years post-treatment

  2. 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.

    Measured: From the end of treatment in the previous study up to 3 years post-treatment

  3. 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.

    Measured: From Day 1 to Month 12

Secondary outcomes (5)

  1. Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection

    Any events (i.e., diagnoses) related to liver disease progression and/or HCV infection considered to be clinically significant by the investigator that began or worsened after Day 1 were documented until the end of the study or initiation of re-treatment for HCV (if applicable). Significant events related to liver disease progression include the development of cirrhosis, events indicative of hepatic decompensation, (including: variceal bleeding, new ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, hepato-renal syndrome, hepatic hydrothorax or other evidence of hepatic decompensation considered to be significant by the investigator), change in the Child-Pugh category (e.g., change from Child-Pugh Class A to Child-Pugh Class B), the occurrence of hepatocellular carcinoma, liver transplantation and/or death.

    Measured: After Day 1 up to 3 years post-treatment

  2. Mean Concentration of Interferon Gamma-induced Protein 10 (IP-10) Over Time

    A plasma sample for IP-10 testing was collected at study visits for all participants, until the end of the study or initiation of re-treatment for HCV (if applicable). IP-10 is used to assess liver fibrosis in participants with chronic liver disease.

    Measured: From Day 1 up to 3 years post-treatment

  3. Mean FibroTest Score Over Time

    A serum sample for FibroTest evaluation was collected at study visits for all participants, until the end of the study or initiation of re-treatment for HCV (if applicable). FibroTest uses six biomarkers to generate a score that correlates to the degree of liver damage in participants. Scores range from 0 to 1, with higher scores indicating more severe liver fibrosis.

    Measured: From Day 1 up to 3 years post-treatment

  4. Mean Aspartate Transaminase to Platelet Ratio Index (APRI) Over Time

    A serum sample for aspartate transaminase evaluation and platelets were collected at study visits for all participants, until the end of the study or initiation of re-treatment for HCV (if applicable). The aspartate transaminase to platelet ratio index (APRI) is used to assess liver fibrosis in participants with chronic liver disease. Scores range from 0 to ≥ 2.0, with scores < 0.5 predictive of no liver fibrosis; scores >1.5 significant fibrosis; and scores > 2.0 indicative of cirrhosis.

    Measured: From Day 1 up to 3 years post-treatment

  5. Mean FibroScan Scores Over Time

    The FibroScan test is used to assess liver fibrosis in participants with chronic liver disease. This was not performed as a study procedure, but any available results from source documents were summarized. For participants with Hepatitis C infection, a Fibroscan score of 2-7 kPa indicates no liver scarring or mild scarring; a score of 8 or 9 is associated with moderate liver scarring; 9-14 indicates severe liver scarring; and 14 or higher is indicative of advanced liver scarring, cirrhosis.

    Measured: Up to 3 years post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2015 (estimated)
  2. Study start22 Jun 2015
  3. Primary completion15 Oct 2019
  4. Study completion15 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
384 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02441283
Sponsor's protocol ID
M13-576
Other IDs
2015-000452-24, 2015
Status last verified
Aug 2020
First submitted
29 Apr 2015
Last updated
21 Sep 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.
Expanded access
Available

Publications

  • 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.

    PubMed 35220658

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing ABT-493 and ABT-530 in people with Hepatitis C, run by AbbVie at 42 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Australia, United Kingdom, Belgium, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: From the end of treatment in the previous study up to 3 years post-treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02441283, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2020.

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