A Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection and Renal Impairment (EXPEDITION-5)

February 6, 2019 updated by: AbbVie

A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir in Renally-Impaired Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection (EXPEDITION-5)

This was a Phase 3b, open-label, non-randomized, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1 - 6 infection without liver cirrhosis or with compensated liver cirrhosis and with chronic renal impairment in participants who were either HCV treatment-naïve (TN) or prior treatment-experienced (TE) with interferon (IFN) or pegylated interferon (PegIFN) with or without ribavirin (RBV), or sofosbuvir (SOF) plus RBV with or without pegIFN.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study included a 42-day screening period, a treatment period of either 8, 12, or 16 weeks, and a 24-week post-treatment period. The duration of treatment was determined by product labeling. Participants received glecaprevir/pibrentasvir (GLE/PIB) 300 mg/120 mg once daily. Participants who completed or prematurely discontinued the treatment period were followed for 24 weeks after their last dose of study drug to monitor safety, hepatitis C virus ribonucleic acid (HCV RNA), and the emergence and persistence of viral substitutions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
101

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Approved

Approved

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2X8
        • Zeidler Ledcor Centre /ID# 160600
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2C7
        • Vancouver ID Research and Care /ID# 160598
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • GIRI Gastrointestinal Research Institute /ID# 160599
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital /ID# 160601
  • Germany
      • Hannover, Germany, 30625
        • Med Hochschule Hanover /ID# 160827
      • Mainz, Germany, 55131
        • Univ Johannes Gutenberg /ID# 160828
    • Baden-Wuerttemberg
      • Mannheim, Baden-Wuerttemberg, Germany, 68167
        • Universitatsklinikum Mannheim /ID# 160829
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60590
        • Universitätsklinikum Frankfurt /ID# 160826
  • Greece
      • Alexandroupolis, Greece, 68100
        • Gen Univ Hosp Alexandroupolis /ID# 160724
      • Athens, Greece, 10676
        • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 160726
      • Thessaloniki, Greece, 54622
        • Bioclinic Thessaloniki /ID# 160723
    • Attiki
      • Athens, Attiki, Greece, 115 27
        • General Hospital of Athens Laiko /ID# 160725
  • Italy
      • Salerno, Italy, 84100
        • A.O. Uni Giovanni e Ruggi /ID# 160720
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • A.O.U. Policlinico S.Orsola-Malpighi /ID# 163349
    • Lazio
      • Roma, Lazio, Italy, 00168
        • Policlinico A. Gemelli /ID# 160719
    • Sicilia
      • Palermo, Sicilia, Italy, 90127
        • Policlinico Paolo Giaccone /Id# 160718
  • Korea, Republic of
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center /ID# 160260
    • Seoul Teugbyeolsi
      • Seongdong, Seoul Teugbyeolsi, Korea, Republic of, 04763
        • Hanyang University Seoul Hospi /ID# 160259
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
        • Severance Hospital /ID# 160261
  • Poland
      • Bialystok, Poland, 15-276
        • Uniwersytecki Szpital Kliniczn /ID# 161081
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-884
        • HepID - Diagnostyka I Terapia /ID# 161083
  • Puerto Rico
      • San Juan, Puerto Rico, 00921-3201
        • VA Caribbean Healthcare System /ID# 160754
      • San Juan, Puerto Rico, 00935
        • School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 160755
  • Spain
      • Barcelona, Spain, 08003
        • Hospital Parc de Salut del Mar /ID# 159975
      • Madrid, Spain, 28041
        • Hospital Universitario Doce de /ID# 159974
    • Malaga
      • Málaga, Malaga, Spain, 29009
        • Hospital Regional de Malaga /ID# 159976
  • Sweden
      • Stockholm, Sweden, SE-141 86
        • Karolinska Uni /ID# 159523
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps Clinic /ID# 159116
      • Pasadena, California, United States, 91105
        • Huntington Medical Foundation /ID# 160653
    • Florida
      • Tampa, Florida, United States, 33606
        • Tampa General Medical Group /ID# 159115
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Northwest Louisiana Nephrology /ID# 160652
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital /ID# 159114
    • New York
      • New Hyde Park, New York, United States, 11040
        • North Shore University Hospital /ID# 159108
      • New York, New York, United States, 10032-3725
        • Columbia Univ Medical Center /ID# 159112
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center /ID# 159113
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-5502
        • University of Pennsylvania /ID# 159117
      • Philadelphia, Pennsylvania, United States, 19107-4414
        • Thomas Jefferson University /ID# 159754
    • Texas
      • San Antonio, Texas, United States, 78215
        • TX Liver Inst, Americ Res Corp /ID# 159111

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female (of non-childbearing potential or using allowed contraceptive methods) at least 18 years of age time of Screening
  • Participant had a positive anti-hepatitis C virus (HCV) antibody (Ab) and plasma HCV ribonucleic acid (RNA) greater than or equal to 1000 IU/mL at the Screening Visit.
  • Participant had an estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m^2 as estimated by the Modification of Diet in Renal Disease (MDRD) method at Screening according to the following formula: eGFR (mL/min/1.73 m^2 ) = 175 × (Serum Creatinine) ^-1.154 × Age^-0.203 × (0.742 if female) × (1.212 if black), or were dialysis dependent. Subjects requiring dialysis had to have been receiving dialysis for at least 1 month prior to enrollment, and may have been on hemodialysis or peritoneal dialysis.
  • Cirrhotic participants only: absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) within 3 months prior to Screening or a negative ultrasound at Screening. Participants who had an ultrasound with results suspicious of HCC followed by a subsequent negative CT or MRI of the liver were eligible for the study.

Exclusion Criteria:

  • Female participants who were pregnant, breastfeeding, or were considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug
  • Current hepatitis B virus (HBV) or human immunodeficiency virus (HIV) infection on screening tests, defined as:
  • Positive test result at Screening for hepatitis B surface antigen (HBsAg), or;
  • HBV deoxyribonucleic acid (DNA) greater than lower limit of quantification (LLOQ) in participants with isolated positive hepatitis B core antibody (HBcAb), (i.e., negative HBsAg and Anti-HBsAg), or;
  • Positive anti-HIV antibody (Ab).
  • Any current or historical clinical evidence of decompensated cirrhosis, including any current or past evidence of Child-Pugh B or C classification, hepatic encephalopathy or variceal bleeding; radiographic evidence of small ascites; or prior or current empiric use of lactulose/rifaximin for neurologic indications. Prophylactic use of beta blockers was not exclusionary.
  • Clinical history of acute renal failure in the 3 months prior to Screening
  • History of severe, life-threatening, or other significant sensitivity to any excipients of the study drugs
  • Clinically significant abnormalities or co-morbidities, or recent (within 6 months prior to study drug administration) alcohol or drug abuse that could preclude adherence to the protocol in the opinion of the investigator
  • Receipt of any investigational or commercially available direct acting anti-HCV agents other than sofosbuvir

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GLE/PIB for 8 weeks
HCV genotype 1,2,4-6 non-cirrhotic, treatment-naive or treatment-experienced; genotype 3 non-cirrhotic, treatment-naïve participants treated with glecaprevir/pibrentasvir (GLE/PIB): three 100 mg/40 mg co-formulated tablets once daily with food for 8 weeks
Drug: Glecaprevir/pibrentasvir
Film-coated tablet
Other Names:
  • MAVYRET
  • ABT-493/ABT-530
Experimental: GLE/PIB for 12 weeks
HCV genotype 1,2,4-6 compensated cirrhosis, treatment-naive or treatment-experienced; genotype 3 compensated cirrhosis, treatment- naïve participants treated with glecaprevir/pibrentasvir (GLE/PIB): three 100 mg/40 mg co-formulated tablets once daily with food for 12 weeks
Drug: Glecaprevir/pibrentasvir
Film-coated tablet
Other Names:
  • MAVYRET
  • ABT-493/ABT-530
Experimental: GLE/PIB for 16 weeks
HCV genotype 3 non-cirrhotic or with compensated cirrhosis, treatment-experienced participants treated with glecaprevir/pibrentasvir (GLE/PIB): three 100 mg/40 mg co-formulated tablets once daily with food for 16 weeks
Drug: Glecaprevir/pibrentasvir
Film-coated tablet
Other Names:
  • MAVYRET
  • ABT-493/ABT-530

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post Dosing (SVR12)
Time Frame: 12 weeks after the last actual dose of study drug
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
12 weeks after the last actual dose of study drug

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With On-treatment Virologic Failure
Time Frame: Up to 16 weeks

On-treatment virologic failure was defined as:

  • Confirmed increase from nadir in hepatitis C virus ribonucleic acid (HCV RNA) defined as confirmed increase of > 1 log (subscript)10(subscript) IU/mL above nadir during treatment; or
  • Confirmed HCV RNA greater than or equal to 100 IU/mL after HCV RNA less than the lower limit of quantification (LLOQ) during study drug treatment; or
  • HCV RNA ≥ LLOQ at the end of treatment with at least 6 weeks of treatment
Up to 16 weeks
Percentage of Participants With Post-treatment Relapse
Time Frame: Up to 12 weeks after the last dose of study drug

Post-treatment relapse was defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) ≥ the lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA < LLOQ at the end of treatment and had post-treatment HCV RNA data; participants who had been shown to be reinfected were not considered to have relapsed.

.
Up to 12 weeks after the last dose of study drug

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 5, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M16-127
  • 2016-004182-60 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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