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Hepatitis C Virus (HCV)Phase 3NCT03212521

Efficacy and Safety of 8-weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve Adults With HCV Genotype 1-6 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤1

A Phase 3 study testing Glecaprevir/Pibrentasvir in people with Hepatitis C Virus (HCV), run by AbbVie at 42 sites in 10 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

A study to evaluate the efficacy and safety of glecaprevir(GLE)/pibrentasvir(PIB) in treatment-naïve participants with chronic hepatitis C virus (HCV) genotypes 1-6 infection and with an aspartate aminotransferase to platelet ratio index (APRI) of less than or equal to 1. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C Virus (HCV)
What is being tested?
Glecaprevir/Pibrentasvir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
42 sitesin 10 countries
Study dates
7 Aug 2017to 13 Aug 2018
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5, or 6 infection. Mixed GT and indeterminate GT may be acceptable.
  • Aspartate aminotransferase (AST) to platelet ratio index (APRI) score of less than or equal to 1, at time of screening.
  • Does not have current active hepatitis B virus infection defined as:
  • positive hepatitis B surface antigen (HBsAg), OR
  • hepatitis B virus (HBV) deoxyribonucleic acid (DNA) > lower limit of quantification (LLOQ) in subjects with isolated positive anti-hepatitis B core (HBc) (i.e., negative HBsAg and anti-hepatitis B surface[HBs])
  • Platelets ≥ 150,000 cells/mm³
Show all 12Show fewer
  • Albumin ≥ lower limit of normal (LLN)
  • Positive anti-HCV antibody (Ab) AND plasma HCV ribonucleic acid (RNA) viral load ≥ 1,000 IU/mL at Screening and for at least 6 months before Screening.
  • No past history/evidence of cirrhosis.
  • No history of hepatocellular carcinoma.
  • Hepatitis C virus treatment-naïve (had not received a single dose of any approved or investigational anti-HCV medication).
  • If female, the subject must not be pregnant, breastfeeding, or considering becoming pregnant during the study and for 30 days after the last dose of study drug.

Who cannot join

None listed.

Trial locations and contacts

42 sites in 10 countries.

42 sites in 10 countries

United States11 sites

  • University of Michigan Hospitals /ID# 161265

    Ann Arbor, Michigan, 48109-5008

  • Univ Maryland School Medicine /ID# 161157

    Baltimore, Maryland, 21201

  • Digestive Disease Associates - Baltimore /ID# 161260

    Baltimore, Maryland, 21229

  • Parkway Medical Center /ID# 161261

    Birmingham, Alabama, 35215

  • University of Vermont Medical Center /ID# 161263

    Burlington, Vermont, 05401-1473

  • Liver Associates of Texas, P.A /ID# 161262

    Houston, Texas, 77030-2783

  • Yale University /ID# 161258

    New Haven, Connecticut, 06510

  • Digestive and Liver Disease Sp /ID# 161259

    Norfolk, Virginia, 23502

  • Arkansas Gastroenterology /ID# 161266

    North Little Rock, Arkansas, 72117

  • Northwest Gastroenterology Cli /ID# 161257

    Portland, Oregon, 97210

  • UC Davis Medical Center /ID# 161138

    Sacramento, California, 95817

Other trials in United States

Spain5 sites

  • Hospital Fundacion Alcorcon /ID# 161436

    Alcorcón, 28922

  • Hospital Clinic de Barcelona /ID# 161437

    Barcelona, 08036

  • Hospital Vall d'Hebron /ID# 162022

    Barcelona, 8035

  • Hosp Uni Virgen de la Victoria /ID# 164383

    Málaga, 29010

  • Complexo Hospitalario universi /ID# 165603

    Pontevedra, 36071

Other trials in Spain

Canada4 sites

  • Brampton Civic Hospital /ID# 161380

    Brampton, Ontario, L6R 3J7

  • South Health Campus /ID# 161385

    Calgary, Alberta, T3M 1M4

  • The Moncton Hospital /ID# 161384

    Moncton, New Brunswick, E1C 6Z8

  • Toronto Liver Centre /ID# 161381

    Toronto, Ontario, M6H 3M1

Other trials in Canada

France4 sites

  • CHU de Besancon - Jean Minjoz /ID# 161485

    Besançon, Doubs, 25000

  • Hopital Saint Joseph /ID# 161571

    Marseille, Bouches-du-Rhone, 13285

  • CHU de Rennes - PONTCHAILLOU /ID# 161492

    Rennes, Brittany Region, 35000

  • Hopitaux de Brabois Adultes /ID# 161482

    Vandœuvre-lès-Nancy, Lorraine, 54500

Other trials in France

Germany4 sites

  • Charité Universitätsmedizin Campus Mitte /ID# 161395

    Berlin, 10117

  • Universitätsklinikum Frankfurt /ID# 161397

    Frankfurt am Main, Hesse, 60590

  • ICH Study Center GmbH & Co KG /ID# 161394

    Hamburg, 20146

  • Universitaetsmedizin der Johannes-Gutenberg Universität Mainz /ID# 161396

    Mainz, Rhineland-Palatinate, 55131

Other trials in Germany

Poland4 sites

  • Uniwersytecki Szpital Kliniczn /ID# 162216

    Bialystok, 15-276

  • HepID - Diagnostyka I Terapia /ID# 162219

    Lublin, Lublin Voivodeship, 20-884

  • ID Clinic /ID# 162217

    Mysłowice, 41-406

  • Centrum Badan Klinicznych /Id# 162218

    Wroclaw, Lower Silesian Voivodeship, 50-349

Other trials in Poland

United Kingdom4 sites

  • Bradford Teaching Hospitals /ID# 161424

    Bradford, BD9 6RJ

  • Glasgow Royal Infirmary /ID# 161458

    Glasgow, G4 0SF

  • Gloucester Royal Hospital /ID# 161423

    Gloucester, GL1 3NN

  • Freeman Hospital /ID# 161459

    Newcastle upon Tyne, NE7 7DN

Other trials in United Kingdom

Russia3 sites

  • South Ural State Medical univ /ID# 163163

    Chelyabinsk, 454052

  • A. F. Agafonov Republican Clin /ID# 163164

    Kazan', Tatarstan, Respublika, 420140

  • A.I. Evdokimov Moscow State Un /ID# 163162

    Moscow, 127473

Other trials in Russia

Bulgaria2 sites

  • DCC Mladost M /ID# 161339

    Varna, 9000

  • DCC Aleksandrovska /ID# 161340

    София, Sofia, 1431

Other trials in Bulgaria

Puerto Rico1 site

  • Innovative Care P.S.C. /ID# 162787

    San Juan, 00959

Other trials in Puerto Rico

About this study

Official title: A Single Arm, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults With Chronic Hepatitis C Virus (HCV) Genotypes 1 - 6 Infection and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤ 1

A study to evaluate the efficacy and safety of glecaprevir(GLE)/pibrentasvir(PIB) in treatment-naïve participants with chronic hepatitis C virus (HCV) genotypes 1-6 infection and with an aspartate aminotransferase to platelet ratio index (APRI) of less than or equal to 1.

Being tested
Glecaprevir/Pibrentasvir
Keywords
chronic hepatitis C virus (HCV), Hepatitis, HCV genotype, aspartate aminotransferase, platelet, Aspartate aminotransferase to Platelet Ratio Index (APRI), glecaprevir, pibrentasvir, Sustained Virologic Response 12 weeks post dosing (SVR12)
Medical subject headings
Hepatitis C, Hepatitis C, Chronic, Hepatitis

What participants receive

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

  • Glecaprevir/PibrentasvirDrug

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

    Glecaprevir/pibrentasvir 100 mg/40 mg co-formulated tablets taken orally as 3 tablets once a day.

Study groups in NCT03212521
Study groupRoleWhat they receive
Glecaprevir/PibrentasvirExperimentalParticipants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 weeks.
Receives: Drug: Glecaprevir/Pibrentasvir

What is being measured

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

  1. Percentage of Participants in the Modified Intention-to-Treat Population 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.

    The 95% confidence interval (95%CI) was calculated using the Wilson's score method.

    Efficacy was to be established if the lower bound of the 95%CI was greater than the threshold of 92.4%, based on the historical rate observed in glecaprevir/pibrentasvir registrational studies in treatment-naïve, non-cirrhotic patients (98.4%) minus a margin of 6%.

    Measured: 12 weeks after the last actual dose of study drug, Week 20

Secondary outcomes (3)

  1. Percentage of Participants in the Intention-to-Treat Population With SVR12

    SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the LLOQ (15 IU/mL) 12 weeks after the last dose of study drug.

    The 95% confidence interval was calculated using the normal approximation to the binomial distribution. Efficacy was to be established if the lower bound of the 95%CI was greater than the threshold of 91.4%, based on the mITT threshold minus an expected 1% rate of non-virological SVR failures.

    Measured: 12 weeks after the last actual dose of study drug, Week 20

  2. Percentage of Participants With On-treatment Virologic Failure

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

    • confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < 15 IU/mL during the Treatment Period; or
    • 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
    • HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment, where the HCV RNA value must be collected on or after Study Drug Day 36 and study drug duration ≥ 36 days.

    Measured: Up to 8 weeks

  3. Percentage of Participants With Post-treatment Relapse

    Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.

    Measured: From the end of treatment (Week 8) through 12 weeks after the last dose of study drug (Week 20)

Timeline

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

  1. First posted11 Jul 2017
  2. Study start7 Aug 2017
  3. Primary completion13 Aug 2018
  4. Study completion13 Aug 2018

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
230 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03212521
Sponsor's protocol ID
M16-133
Other IDs
2016-004876-23, 2016
Status last verified
Aug 2018
First submitted
7 Jul 2017
Last updated
4 Sep 2019
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

  • Fontana RJ, Lens S, McPherson S, Elkhashab M, Ankoma-Sey V, Bondin M, Dos Santos AGP, Xue Z, Trinh R, Porcalla A, Zeuzem S. Efficacy and Safety of 8 Weeks of Glecaprevir/Pibrentasvir in Treatment-Naive, HCV-Infected Patients with APRI </= 1 in a Single-Arm, Open-Label, Multicenter Study. Adv Ther. 2019 Dec;36(12):3458-3470. doi: 10.1007/s12325-019-01123-0. Epub 2019 Oct 23.

    PubMed 31646465

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Glecaprevir/Pibrentasvir in people with Hepatitis C Virus (HCV), run by AbbVie at 42 sites in 10 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 12 inclusion and 0 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 Sep 2019. 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, Spain, Canada, France, Germany and 5 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 Sep 2019). 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 in the Modified Intention-to-Treat Population With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) (time frame: 12 weeks after the last actual dose of study drug, Week 20). 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 NCT03212521, 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 Sep 2019; AzTrials last refreshed its copy on 8 Nov 2026.

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