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

Primary Purpose

Hepatitis C

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

ABT-493

ABT-530

About this trial

This is an interventional other trial for Hepatitis C focused on measuring Chronic hepatitis C, Hepatitis C virus, Sustained virologic response, Hepatitis C, Direct Acting Antiviral

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

HCV-infected Participants

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

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.

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT02441283

First Posted

April 29, 2015

Last Updated

August 31, 2020

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT02441283

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

June 22, 2015 (Actual)

Primary Completion Date

October 15, 2019 (Actual)

Study Completion Date

October 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C

Keywords

Chronic hepatitis C, Hepatitis C virus, Sustained virologic response, Hepatitis C, Direct Acting Antiviral

7. Study Design

Primary Purpose

Other

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

384 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HCV-infected Participants

Arm Type

No Intervention

Arm Description

Intervention Type

Drug

Intervention Name(s)

ABT-493

Other Intervention Name(s)

Glecaprevir

Intervention Description

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

Intervention Name(s)

ABT-530

Other Intervention Name(s)

Pibrentasvir

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

Description

Time Frame

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

Title

Number of Participants With Persistence of Resistance-Associated Amino Acid Variants Among Those Experiencing Virologic Failure

Description

Time Frame

From Day 1 to Month 12

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

After Day 1 up to 3 years post-treatment

Title

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

Description

Time Frame

From Day 1 up to 3 years post-treatment

Title

Mean FibroTest Score Over Time

Description

Time Frame

From Day 1 up to 3 years post-treatment

Title

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

Description

Time Frame

From Day 1 up to 3 years post-treatment

Title

Mean FibroScan Scores Over Time

Description

Time Frame

Up to 3 years post-treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AbbVie Inc.

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

Digestive Health Specialists of the Southeast /ID# 136725

City

Dothan

State/Province

Alabama

ZIP/Postal Code

36305

Country

United States

Facility Name

Felizarta /ID# 141033

City

Bakersfield

State/Province

California

ZIP/Postal Code

93301

Country

United States

Facility Name

Southern California Res. Ctr. /ID# 141799

City

Coronado

State/Province

California

ZIP/Postal Code

92118-1408

Country

United States

Facility Name

Research & Education, Inc. /ID# 169591

City

San Diego

State/Province

California

ZIP/Postal Code

92105

Country

United States

Facility Name

eStudySite San Diego /ID# 141040

City

San Diego

State/Province

California

ZIP/Postal Code

92120

Country

United States

Facility Name

eStudySite San Diego /ID# 141047

City

San Diego

State/Province

California

ZIP/Postal Code

92120

Country

United States

Facility Name

eStudySite San Diego /ID# 141048

City

San Diego

State/Province

California

ZIP/Postal Code

92120

Country

United States

Facility Name

Midway Immunology and Research /ID# 169477

City

Fort Pierce

State/Province

Florida

ZIP/Postal Code

34982

Country

United States

Facility Name

Delta Research Partners /ID# 141028

City

Bastrop

State/Province

Louisiana

ZIP/Postal Code

71220

Country

United States

Facility Name

Louisiana Research Ctr. LLC /ID# 141024

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71105-6800

Country

United States

Facility Name

Henry Ford Health System /ID# 141039

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Binghamton Gastroenterology /ID# 141026

City

Binghamton

State/Province

New York

ZIP/Postal Code

13903

Country

United States

Facility Name

Carolinas Center for Liver Dis /ID# 155390

City

Statesville

State/Province

North Carolina

ZIP/Postal Code

28677-3471

Country

United States

Facility Name

Northwest Gastroenterology Cli /ID# 141036

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Gastro One /ID# 169478

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

Quality Medical Research, PLLC /ID# 141042

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37211

Country

United States

Facility Name

TX Clinical Research Institute /ID# 141037

City

Arlington

State/Province

Texas

ZIP/Postal Code

76012

Country

United States

Facility Name

Inquest Clinical Research /ID# 141045

City

Baytown

State/Province

Texas

ZIP/Postal Code

77521-2415

Country

United States

Facility Name

TX Liver Inst, Americ Res Corp /ID# 136727

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78215

Country

United States

Facility Name

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

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23226

Country

United States

Facility Name

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

City

Darlinghurst

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

St. Vincents Hospital /ID# 155394

City

East Lismore

State/Province

New South Wales

ZIP/Postal Code

2480

Country

Australia

Facility Name

Westmead Hospital /ID# 155392

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Royal Brisbane and Women's Hospital /ID# 155396

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

Royal Adelaide Hospital /ID# 155391

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Royal Melbourne Hospital /ID# 155393

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

Cliniques Universitaires Saint Luc /ID# 155397

City

Woluwe-Saint-Lambert

State/Province

Bruxelles-Capitale

ZIP/Postal Code

1200

Country

Belgium

Facility Name

CHU St. Pierre /ID# 155399

City

Brussels

ZIP/Postal Code

1000

Country

Belgium

Facility Name

UZ Leuven /ID# 155398

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

University of Calgary /ID# 155400

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4Z6

Country

Canada

Facility Name

Toronto Liver Centre /ID# 155401

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M6H 3M1

Country

Canada

Facility Name

Universitätsklinikum Frankfurt /ID# 169817

City

Frankfurt am Main

State/Province

Hessen

ZIP/Postal Code

60590

Country

Germany

Facility Name

Mauss, Schmutz, Hegener, Athma /ID# 155402

City

Dusseldorf

ZIP/Postal Code

40237

Country

Germany

Facility Name

Gastroenterologisch-Hepatologi /ID# 169820

City

Kiel

ZIP/Postal Code

24146

Country

Germany

Facility Name

Auckland City Hospital /ID# 155403

City

Auckland

ZIP/Postal Code

1023

Country

New Zealand

Facility Name

Gastro-Hepato & Geriatric Ctr /ID# 141060

City

Ponce

ZIP/Postal Code

00716

Country

Puerto Rico

Facility Name

Klinical Investigations Group /ID# 141059

City

San Juan

ZIP/Postal Code

00909

Country

Puerto Rico

Facility Name

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

City

San Juan

ZIP/Postal Code

00959

Country

Puerto Rico

Facility Name

The Royal London Hospital /ID# 155405

City

London

State/Province

London, City Of

ZIP/Postal Code

E1 1BB

Country

United Kingdom

Facility Name

King's College Hospital NHS /ID# 155406

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

St. Mary's Hospital /ID# 155404

City

London

ZIP/Postal Code

W2 1NY

Country

United Kingdom

Facility Name

Derriford Hospital /ID# 155407

City

Plymouth

ZIP/Postal Code

PL6 8DH

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing Time Frame

Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.

IPD Sharing 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.

IPD Sharing URL

https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

Citations:

PubMed Identifier

35220658

Citation

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.

Results Reference

derived

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

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

Hepatitis C

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial