Efficacy Study Of Oral Glecaprevir/Pibrentasvir Tablet In Pediatric (12 Years and Older) And Adult Treatment-Naive Participants With Chronic Hepatitis C Genotypes 1 To 6 And Liver Cirrhosis (EASY)

June 8, 2022 updated by: AbbVie

REAl World Evidence Of The Effectiveness And Clinical Practice Use Of Glecaprevir/Pibrentasvir For 8 Weeks Treatment In Patients With Chronic HepatitiS C GenotYpes 1 to 6 And Liver Cirrhosis In Russian Federation (EASY)

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) and liver cancer leaving trial participants with need for liver transplant. The purpose of this study is to see how effective Glecaprevir/Pibrentasvir (GLE/PIB) is in a real world setting of participants with chronic HCV genotypes 1 to 6 and liver cirrhosis who have never received any treatment for HCV.

GLE/PIB is a drug developed for the treatment of HCV infection. This is a prospective (future), observational study in treatment-naive (those who have not received treatment) participants with HCV genotypes 1 to 6 and compensated cirrhosis. All study participants will receive GLE/PIB as prescribed by their study doctor in accordance with approved local label. Pediatric (12 years and older) and adult participants with a diagnosis of HCV genotypes 1 to 6 and compensated cirrhosis will be enrolled in the study in Russian Federation.

Participants will receive GLE/PIB tablets to be taken by mouth daily according to their physicians' prescription. The total duration of the study is 20 weeks, with a treatment period of 8 weeks and a follow up period of 12 weeks.

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)

99

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, 454052
        • South Ural State Medical University /ID# 225501
      • Irkutsk, Russian Federation, 664035
        • Irkutsk Regional Center for the Prevention and Control of AIDS and Infections /ID# 225499
      • Oryol, Russian Federation, 302038
        • S. P. Botkin City Hospital /ID# 225500
      • Samara, Russian Federation, 443029
        • Samara Region Clinical HIV/AIDS Prevention and Control Center /ID# 222582
      • Stavropol, Russian Federation, 355017
        • Stavropol State Medical University /ID# 226589
      • Ulyanovsk, Russian Federation, 432063
        • Medical center Academy /ID# 226587

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Treatment-naive Pediatric (12 years and older) and adult participants with confirmed Chronic Hepatitis C (CHC), genotypes 1, 2, 3, 4, 5, or 6 with compensated cirrhosis, being treated with oral Glecaprevir/Pibrentasvir (GLE/PIB) according to standard of care, international guidelines and in line with the current local label.

Description

Inclusion Criteria:

  • Treatment-naïve male or female with confirmed CHC, genotypes 1, 2, 3, 4, 5, or 6, with compensated liver cirrhosis, receiving combination therapy with the all oral GLE/PIB regimen for 8 weeks according to standard of care, international guidelines and in line with the current local label.
  • Participants may be enrolled up to 4 weeks after treatment initiation.

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 (GLE/PIB)
Participants will receive GLE/PIB over 8 weeks of therapy as prescribed by their physicians.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Of Participants Achieving Sustained Virologic Response At 12 Weeks (SVR12)
Time Frame: At Week 20
SVR12 is defined as Hepatitis C Virus (HCV) RNA < 50 IU/ml or < lower limit of quantification/detection (LLoQ/D) available at the site 12 weeks (i.e.,>=70 days) after the last actual dose.
At Week 20

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number Of Participants Achieving SVR12 After Last Actual Dose Of GLE/PIB At 12 Weeks In Subgroups Of Interest
Time Frame: At Week 20
SVR12 is defined as HCV RNA < lower limit of quantification/detection (LLoQ/D) 12 weeks (i.e., >=70 days) 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.
At Week 20
Number Of Participants With Co-morbidities
Time Frame: At Week 20
Participants who have other existing medical conditions.
At Week 20
Number Of Participants Taking Concomitant Medication
Time Frame: At Week 20
Participants who take other medications along with Glecaprevir/Pibrentasvir (GLE/PIB).
At Week 20
Percentage Of GLE/PIB Dose Taken In Relation To The Prescribed Target Dose
Time Frame: At Week 20
Percentage of GLE/PIB dose taken by participant report in relation to the prescribed target dose (number of pills taken out of the number that should have been taken).
At Week 20
Number of Participants With Adverse Events
Time Frame: Baseline (Week 0) To 30 days post last dose
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug. 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.
Baseline (Week 0) To 30 days post last dose
Percentage of Participants With Shifts in Clinical Laboratory Values
Time Frame: Baseline (Week 0) to Week 20
Percentage of participants with clinically significant change in laboratory parameters of interest (hematology, biochemistry, virology, coagulation, and urinalysis), post-baseline during treatment, will be summarized.
Baseline (Week 0) to Week 20
Number Of Health Care Resource Utilization (HCRU) Over Time Overall And By Subpopulations Of Interest
Time Frame: At Week 20
HCRU for a participant will be the total number of visits/touchpoints (face to face or phone call) with a Health Care Professional (HCP) or designee in relation to their Hepatitic C Virus (HCV) infection during the study.
At Week 20

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.

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)

May 29, 2020

Primary Completion (Actual)

June 11, 2021

Study Completion (Actual)

June 11, 2021

Study Registration Dates

First Submitted

April 16, 2020

First Submitted That Met QC Criteria

April 16, 2020

First Posted (Actual)

April 20, 2020

Study Record Updates

Last Update Posted (Actual)

June 9, 2022

Last Update Submitted That Met QC Criteria

June 8, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P20-276

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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