Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study (MAGELLAN-3)

April 7, 2022 updated by: AbbVie

An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Combination With Sofosbuvir and Ribavirin in Chronic Hepatitis C (HCV) Infected Subjects Who Have Experienced Virologic Failure in AbbVie HCV Clinical Studies (MAGELLAN-3)

The purpose of this study was to evaluate the efficacy and safety of co-administration of glecaprevir (ABT-493)/pibrentasvir (ABT 530) plus sofosbuvir (SOF) plus ribavirin (RBV) in hepatitis C virus (HCV) genotype (GT) 1 - 6-infected participants (including non-cirrhotic, or cirrhotic with compensated cirrhosis participants) who had experienced virologic failure in an AbbVie parent clinical study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study enrolled HCV infected adults who had experienced virologic failure following treatment with glecaprevir/pibrentasvir or paritaprevir/ritonavir/ombitasvir + dasabuvir (DSV) (3D) or paritaprevir/ritonavir/ombitasvir (2D) regimens in one of the following AbbVie hepatitis C virus parent studies:

  • M13-594 (NCT02640157)
  • M13-596 (NCT02692703)
  • M14-172 (NCT02642432)
  • M14-242 (NCT02493855)
  • M14-868 (NCT02243293)
  • M15-410 (NCT02446717)
  • M15-592 (NCT03222583)
  • M16-126 (NCT02966795)
  • M16-135 (NCT03089944)

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital /ID# 200944
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • The Royal Melbourne Hospital /ID# 155727
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary /ID# 155726
  • China
      • Beijing, China, 100015
        • Beijing Di Tan Hospital, Capital Medical University /ID# 218496
      • Chengdu, China, 610041
        • West China Hospital, Sichuan University /ID# 217613
      • Chongqing, China, 400038
        • The First Hospital Affiliated to AMU (Southwest Hospital) /ID# 218494
      • Fuzhou, China, 350025
        • Mengchao Hepatobiliary Hospital of Fujian Medical University /ID# 218495
  • Germany
      • Hamburg, Germany, 20099
        • Asklepios Klinik St. Georg /ID# 155733
    • Nordrhein-Westfalen
      • Düsseldorf, Nordrhein-Westfalen, Germany, 40237
        • Zentru fur HIV und Heaptogastroenterologie /ID# 155592
  • Korea, Republic of
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center /ID# 214844
  • New Zealand
      • Otago, New Zealand, 9016
        • Dunedin Hospital /ID# 155591
    • Auckland
      • Grafton, Auckland, New Zealand, 1023
        • Auckland City Hospital /ID# 200945
    • Waikato
      • Hamilton, Waikato, New Zealand, 3240
        • Waikato Hospital /ID# 155728
  • Russian Federation
    • Samarskaya Oblast
      • Samara, Samarskaya Oblast, Russian Federation, 443063
        • Medical Company Hepatolog /ID# 214314
  • Spain
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro, Majadahonda /ID# 155734
  • Sweden
      • Solna, Sweden, 171 64
        • Duplicate_Karolinska Univ Sjukhuset /ID# 155735
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital, Universitätsspital Bern /ID# 155716
  • United Kingdom
      • London, United Kingdom, W2 1NY
        • Duplicate_Imperial College Healthcare NHS Trust /ID# 155718
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • Digestive Health Specialists of the Southeast /ID# 155719
    • California
      • Los Angeles, California, United States, 90036
        • Ruane Clinical Research Group /ID# 155714
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Digestive Disease Associates - Baltimore /ID# 155713
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System /ID# 155720
    • New York
      • Buffalo, New York, United States, 14203
        • University of Buffalo /ID# 155721
    • North Carolina
      • Statesville, North Carolina, United States, 28677
        • Carolinas Center For Liver Dis /ID# 155731
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastro One /ID# 155729
    • Texas
      • San Antonio, Texas, United States, 78215
        • TX Liver Inst, Americ Res Corp /ID# 157881

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects must be adults (18 years of age or older) or adolescents (12 to less than 18 years of age weighing at least 35 kg).
  • Subject must have experienced virologic failure during or after treatment with ABT-493/ABT-530 in an AbbVie HCV parent study. Subjects who have experienced virologic failure during or after receiving ombitasvir/paritaprevir/r + dasabuvir (3D), or ombitasvir/paritaprevir/r (2D) in an AbbVie HCV parent study may be enrolled at AbbVie's discretion. Treatment in the parent study must have been completed or discontinued at least 1 month prior to the Screening Visit.
  • Subjects must be able to understand and adhere to the study visit schedule and all other protocol requirements.
  • Cirrhotic subjects must have compensated cirrhosis, (Child-Pugh score of ≤ 6) at Screening and no current or past evidence of Child-Pugh B or C Classification or no clinical history of liver decompensation, including ascites noted on physical exam, hepatic encephalopathy or esophageal variceal bleeding.
  • Cirrhotic subjects must have absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound (US), computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or a negative US at Screening.

Exclusion Criteria:

  • History of severe, life-threatening or other clinically significant sensitivity to any study drug or drug component.
  • Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or for 4 months after the last dose of study drug, or as directed per the local RBV label, whichever is more restrictive.
  • Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
  • Positive test result at Screening for hepatitis B surface antigen (HBsAg).
  • Screening laboratory analyses showing calculated creatinine clearance < 30 mL/min.
  • Discontinuation from the AbbVie HCV parent study for reasons other than virologic failure (e.g., non-adherence, lost to follow-up, and/or the occurrence of an adverse event).
  • Receipt of any HCV treatment after failing the treatment regimen in the AbbVie HCV parent study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glecaprevir/Pibrentasvir + SOF + RBV for 12 weeks
Participants without cirrhosis who had non-genotype 3 infection and were naïve to protease inhibitor (PI) and/or nonstructural viral protein 5A inhibitor (NS5Ai) prior to participation in AbbVie HCV parent study received daily treatment with glecaprevir/pibrentasvir (GLE/PIB) 300 mg/120 mg plus sofosbuvir (SOF) 400 mg plus twice-daily weight-based ribavirin (RBV) 600 mg - 1200 mg daily total for 12 weeks.
Drug: Glecaprevir/Pibrentasvir
Coformulated tablet for oral administration
Other Names:
  • MAVYRET
  • ABT-493/ABT-530
  • MAVIRET
Drug: Sofosbuvir
Tablet for oral administration
Other Names:
  • SOVALDI
Drug: Ribavirin
Tablet for oral administration
Experimental: Glecaprevir/Pibrentasvir + SOF + RBV for 16 weeks
Participants with genotype 3, and/or compensated cirrhosis, and/or experience with PI and/or NS5Ai prior to participation in Abbvie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 16 weeks.
Drug: Glecaprevir/Pibrentasvir
Coformulated tablet for oral administration
Other Names:
  • MAVYRET
  • ABT-493/ABT-530
  • MAVIRET
Drug: Sofosbuvir
Tablet for oral administration
Other Names:
  • SOVALDI
Drug: Ribavirin
Tablet for oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Time Frame: 12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen.
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug.
12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With On-treatment Virologic Failure
Time Frame: 12 or 16 weeks depending on the treatment regimen

On-treatment virologic failure was defined as meeting one of the following:

  • confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) at any time point during the treatment period; or
  • confirmed HCV RNA greater than or equal to 100 IU/mL after HCV RNA < 15 IU/mL during the treatment period, or
  • HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment.
12 or 16 weeks depending on the treatment regimen
Percentage of Participants With Post-treatment Relapse
Time Frame: From the end of treatment (Week 12 or 16) through 12 weeks after the last dose of study drug (Weeks 24 or 28 depending on the treatment regimen).
Post-treatment relapse was defined as confirmed HCV RNA greater than or equal to 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < 15 IU/mL at the end of treatment, and had post-treatment HCV RNA data; participants who had been shown to be re-infected were not considered to have relapsed.
From the end of treatment (Week 12 or 16) through 12 weeks after the last dose of study drug (Weeks 24 or 28 depending on the treatment regimen).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2016

Primary Completion (Actual)

May 7, 2021

Study Completion (Actual)

July 30, 2021

Study Registration Dates

First Submitted

October 19, 2016

First Submitted That Met QC Criteria

October 19, 2016

First Posted (Estimate)

October 20, 2016

Study Record Updates

Last Update Posted (Actual)

May 4, 2022

Last Update Submitted That Met QC Criteria

April 7, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M15-942
  • 2016-002491-26 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

For details on when studies are available for sharing, please refer to the link below.

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 Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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