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Hepatitis C Virus InfectionPhase 3MAGELLAN-3NCT02939989

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

A Phase 3 study testing Sofosbuvir, Glecaprevir/Pibrentasvir and Ribavirin in people with Hepatitis C Virus Infection, run by AbbVie at 26 sites in 12 countries.

Completed

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

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 12 to 99 years
Conditions the study is for
Hepatitis C Virus Infection
What is being tested?
Sofosbuvir, Glecaprevir/Pibrentasvir and Ribavirin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
26 sitesin 12 countries
Study dates
21 Nov 2016to 30 Jul 2021
Phase
Phase 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 12 to 99 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

26 sites in 12 countries.

26 sites in 12 countries

United States8 sites

  • Digestive Disease Associates - Baltimore /ID# 155713

    Baltimore, Maryland, 21229

  • University of Buffalo /ID# 155721

    Buffalo, New York, 14203

  • Henry Ford Health System /ID# 155720

    Detroit, Michigan, 48202

  • Digestive Health Specialists of the Southeast /ID# 155719

    Dothan, Alabama, 36305

  • Gastro One /ID# 155729

    Germantown, Tennessee, 38138

  • Ruane Clinical Research Group /ID# 155714

    Los Angeles, California, 90036

  • TX Liver Inst, Americ Res Corp /ID# 157881

    San Antonio, Texas, 78215

  • Carolinas Center For Liver Dis /ID# 155731

    Statesville, North Carolina, 28677

Other trials in United States

China4 sites

  • Beijing Di Tan Hospital, Capital Medical University /ID# 218496

    Beijing, 100015

  • West China Hospital, Sichuan University /ID# 217613

    Chengdu, 610041

  • The First Hospital Affiliated to AMU (Southwest Hospital) /ID# 218494

    Chongqing, 400038

  • Mengchao Hepatobiliary Hospital of Fujian Medical University /ID# 218495

    Fuzhou, 350025

Other trials in China

New Zealand3 sites

  • Auckland City Hospital /ID# 200945

    Grafton, Auckland, 1023

  • Waikato Hospital /ID# 155728

    Hamilton, Waikato Region, 3240

  • Dunedin Hospital /ID# 155591

    Otago, Otago, 9016

Other trials in New Zealand

Australia2 sites

  • Royal Brisbane and Women's Hospital /ID# 200944

    Herston, Queensland, 4029

  • The Royal Melbourne Hospital /ID# 155727

    Parkville, Victoria, 3050

Other trials in Australia

Germany2 sites

  • Zentru fur HIV und Heaptogastroenterologie /ID# 155592

    Düsseldorf, North Rhine-Westphalia, 40237

  • Asklepios Klinik St. Georg /ID# 155733

    Hamburg, 20099

Other trials in Germany

Canada1 site

  • University of Calgary /ID# 155726

    Calgary, Alberta, T2N 4Z6

Other trials in Canada

Russia1 site

  • Medical Company Hepatolog /ID# 214314

    Samara, Samara Oblast, 443063

Other trials in Russia

South Korea1 site

  • Samsung Medical Center /ID# 214844

    Seoul, 06351

Other trials in South Korea

Spain1 site

  • Hospital Universitario Puerta de Hierro, Majadahonda /ID# 155734

    Majadahonda, Madrid, 28222

Other trials in Spain

Sweden1 site

  • Duplicate_Karolinska Univ Sjukhuset /ID# 155735

    Solna, 171 64

Other trials in Sweden

Switzerland1 site

  • Inselspital, Universitätsspital Bern /ID# 155716

    Bern, 3010

Other trials in Switzerland

United Kingdom1 site

  • Duplicate_Imperial College Healthcare NHS Trust /ID# 155718

    London, W2 1NY

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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)
Being tested
Sofosbuvir, Glecaprevir/Pibrentasvir, Ribavirin
Keywords
Chronic Hepatitis C (HCV), HCV Genotype 1 (HCV GT1), HCV Genotype 2 (HCV GT2), HCV Genotype 3 (HCV GT3), HCV Genotype 4 (HCV GT4), HCV Genotype 5 (HCV GT5), HCV Genotype 6 (HCV GT6), Compensated Cirrhosis, Non-cirrhotics, Virologic failure
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.

  • SofosbuvirDrug

    Also called SOVALDI

    Tablet for oral administration

  • Glecaprevir/PibrentasvirDrug

    Also called ABT-493/ABT-530, MAVYRET, MAVIRET

    Coformulated tablet for oral administration

  • RibavirinDrug

    Tablet for oral administration

Study groups in NCT02939989
Study groupRoleWhat they receive
Glecaprevir/Pibrentasvir + SOF + RBV for 12 weeksExperimentalParticipants 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.
Receives: Drug: Sofosbuvir; Drug: Glecaprevir/Pibrentasvir; Drug: Ribavirin
Glecaprevir/Pibrentasvir + SOF + RBV for 16 weeksExperimentalParticipants 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.
Receives: Drug: Sofosbuvir; Drug: Glecaprevir/Pibrentasvir; Drug: Ribavirin

What is being measured

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

  1. Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

    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.

    Measured: 12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen.

Secondary outcomes (2)

  1. Percentage of Participants With On-treatment Virologic Failure

    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.

    Measured: 12 or 16 weeks depending on the treatment regimen

  2. Percentage of Participants With Post-treatment Relapse

    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.

    Measured: 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).

Timeline

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

  1. First posted20 Oct 2016 (estimated)
  2. Study start21 Nov 2016
  3. Primary completion7 May 2021
  4. Study completion30 Jul 2021

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02939989
Sponsor's protocol ID
M15-942
Other IDs
2016-002491-26, 2016
Acronym
MAGELLAN-3
Status last verified
Apr 2022
First submitted
19 Oct 2016
Last updated
4 May 2022
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

  • Wyles D, Weiland O, Yao B, Weilert F, Dufour JF, Gordon SC, Stoehr A, Brown A, Mauss S, Zhang Z, Pilot-Matias T, Rodrigues L Jr, Mensa FJ, Poordad F. Retreatment of patients who failed glecaprevir/pibrentasvir treatment for hepatitis C virus infection. J Hepatol. 2019 May;70(5):1019-1023. doi: 10.1016/j.jhep.2019.01.031. Epub 2019 Mar 8. No abstract available.

    PubMed 30857780

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sofosbuvir, Glecaprevir/Pibrentasvir and Ribavirin in people with Hepatitis C Virus Infection, run by AbbVie at 26 sites in 12 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 7 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 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, China, New Zealand, Australia, Germany and 7 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 phase mean?

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 4 May 2022). 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 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.). 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 NCT02939989, 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 4 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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