Study of Oral Glecaprevir/Pibrentasvir Tablets in Participants Aged 12 Years or Older With Chronic Hepatitis C to Assess Sustained Virological Response (CHOICE)

August 9, 2023 updated by: AbbVie

Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir/Pibrentasvir in DAA Treatment-Experienced Patients With Chronic Hepatitis C Genotype 1 in Russian Federation (CHOICE)

Hepatitis C virus (HCV) infection is among the most common of all chronic liver diseases. HCV predominantly affects liver cells and causes the liver to become inflamed and damaged. This can lead to cirrhosis (scarring of the liver), liver cancer or the need for liver transplant. This study will evaluate how effective glecaprevir/pibrentasvir (GLE/PIB) is in participants with chronic HCV infection. Effectiveness will be assessed as the achievement of sustained virologic response.

GLE/PIB is an approved drug for the treatment of HCV. Participants 12 years or older with chronic HCV infection will be enrolled. This is a prospective (conducted in future) study in therapy of direct-acting antiviral (DAA) treatment-experienced participants with chronic hepatitis C genotype 1. Around 67 participants will be enrolled at multiple sites in Russian Federation.

Participants will receive oral GLE/PIB tablets as prescribed by the physician in accordance with local clinical practice, international guidelines and/or label. Prescription is independent from this study and is decided before providing opportunity to the participate in the study.

There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 12 weeks.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

42

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

  • Russian Federation
      • Chelyabinsk, Russian Federation, 454048
        • South Ural State Medical University /ID# 226555
      • Domodedovo, Russian Federation, 142007
        • LLC Center of Targeted Therapy /ID# 239529
      • Irkutsk, Russian Federation, 664035
        • Irkutsk Regional Center for the Prevention and Control of AIDS and Infections /ID# 229509
      • Krasnodar, Russian Federation, 350000
        • Specialized Clinical Infectious Diseases Hospital /ID# 229814
      • Moscow, Russian Federation, 125310
        • Infectious Clinical Hosp #1 /ID# 225063
      • Nizhniy Novgorod, Russian Federation, 603022
        • Infectious Clinical Hospita l#2 /ID# 243217
      • Oryol, Russian Federation, 302038
        • S. P. Botkin City Hospital /ID# 229510
      • Samara, Russian Federation, 443029
        • Samara Region Clinical HIV/AIDS Prevention and Control Center /ID# 226591
      • St. Petersburg, Russian Federation, 190103
        • Saint-Petersburg AIDS Center /ID# 239357
      • Stavropol, Russian Federation, 355017
        • Stavropol State Medical University /ID# 243216

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 and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants with hepatitis C virus (HCV) infection of genotype 1 prescribed with glecaprevir/pibrentasvir in accordance with local clinical practice and label.

Description

Inclusion Criteria:

  • Direct-acting antiviral treatment-experienced participants with confirmed chronic hepatitis C (CHC) genotype 1, receiving combination therapy with the all oral glecaprevir/pibrentasvir (GLE/PIB) regimens according to standard of care, international guidelines and in line with the current local label.
  • Participants can enroll up to 4 weeks after starting treatment

Exclusion Criteria:

- Participating or intending to participate in a concurrent interventional therapeutic trial.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Participants treated with Glecaprevir/Pibrentasvir
Participants will receive glecaprevir/pibrentasvir (GLE/PIB) as prescribed by physician in accordance with local clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Sustained Virological Response (SVR) at Week 12 (SVR12)
Time Frame: Week 12 after the end of treatment
SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < 50 IU/ml or lower limit of quantification/detection (LLoQ/D) available at the site at Week 12 after the last actual dose.
Week 12 after the end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving SVR12
Time Frame: Week 12 after the end of treatment
SVR12 is defined as HCV RNA < LLoQ/D 12 weeks after the last actual dose of GLE/PIB with a sensitive polymerase chain reaction (PCR) available in the clinical site in the settings of the Russian Federation in subgroups of interest.
Week 12 after the end of treatment
Number of Participants With Co-morbidities and Taking Concomitant Medication
Time Frame: Up to Week 12 after the end of treatment
Number of participants with co-morbidities and taking concomitant medication of interest report will be calculated.
Up to Week 12 after the end of treatment
Health Care Resource Utilization (HCRU)
Time Frame: Up to Week 12 after the end of treatment
HCRU will be total number of visits/touchpoints (face to face or phone call) with a Health Care Provider (HCP) or designee in relation to their HCV infection during the study as recorded overall and by subpopulations of interest.
Up to Week 12 after the end of treatment
Percent of Glecaprevir/Pibrentasvir Dose Taken by Participant Report in Relation to the Prescribed Target Dose
Time Frame: Up to Week 12 after the end of treatment
Number of pills taken out of the number that should have been taken will be calculated.
Up to Week 12 after the end of treatment
Number of Participants With Adverse Events (AEs)
Time Frame: Up to Week 12 after the end of treatment
An adverse event (AE) is defined as any untoward medical occurrence in a patient which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug overall and in subgroups of interest. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Up to Week 12 after the end of treatment
Percentage of Participants Who Experienced Post-Baseline Shifts in Clinical Laboratory Values
Time Frame: Up to Week 12 after the end of treatment
Percentage of participants who experience post-baseline shifts during treatment in clinical laboratory values will be summarized overall and in subgroups of interest.
Up to Week 12 after the end of treatment

Collaborators and Investigators

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

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., 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.

Helpful Links

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)

October 7, 2020

Primary Completion (Actual)

September 3, 2022

Study Completion (Actual)

September 3, 2022

Study Registration Dates

First Submitted

September 30, 2020

First Submitted That Met QC Criteria

September 30, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P20-397

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

No

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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