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

Sponsor

AbbVie (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04577482

Collaborator

(none)

Enrollment

Locations

23.7

Anticipated Duration (Months)

4.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Virus (HCV)

Study Design

Study Type:

Observational

Actual Enrollment :

42 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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)

Actual Study Start Date :

Oct 7, 2020

Anticipated Primary Completion Date :

Sep 28, 2022

Anticipated Study Completion Date :

Sep 28, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Percentage of Participants Achieving Sustained Virological Response (SVR) at Week 12 (SVR12) [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.

Secondary Outcome Measures

Percentage of Participants Achieving SVR12 [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.
Number of Participants With Co-morbidities and Taking Concomitant Medication [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.
Health Care Resource Utilization (HCRU) [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.
Percent of Glecaprevir/Pibrentasvir Dose Taken by Participant Report in Relation to the Prescribed Target Dose [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.
Number of Participants With Adverse Events (AEs) [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.
Percentage of Participants Who Experienced Post-Baseline Shifts in Clinical Laboratory Values [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

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