Study of Oral Glecaprevir/Pibrentasvir Tablets in Participants Aged 12 Years or Older With Chronic Hepatitis C to Assess Sustained Virological Response
CHOICE
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)
1 other identifier
observational
42
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2020
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2020
CompletedStudy Start
First participant enrolled
October 7, 2020
CompletedFirst Posted
Study publicly available on registry
October 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 3, 2022
CompletedAugust 14, 2023
August 1, 2023
1.9 years
September 30, 2020
August 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Sustained Virological Response (SVR) at Week 12 (SVR12)
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 Outcomes (6)
Percentage of Participants Achieving SVR12
Week 12 after the end of treatment
Number of Participants With Co-morbidities and Taking Concomitant Medication
Up to Week 12 after the end of treatment
Health Care Resource Utilization (HCRU)
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
Up to Week 12 after the end of treatment
Number of Participants With Adverse Events (AEs)
Up to Week 12 after the end of treatment
- +1 more secondary outcomes
Study Arms (1)
Participants treated with Glecaprevir/Pibrentasvir
Participants will receive glecaprevir/pibrentasvir (GLE/PIB) as prescribed by physician in accordance with local clinical practice.
Eligibility Criteria
Participants with hepatitis C virus (HCV) infection of genotype 1 prescribed with glecaprevir/pibrentasvir in accordance with local clinical practice and label.
You may qualify if:
- 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
You may not qualify if:
- \- Participating or intending to participate in a concurrent interventional therapeutic trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (10)
South Ural State Medical University /ID# 226555
Chelyabinsk, 454048, Russia
LLC Center of Targeted Therapy /ID# 239529
Domodedovo, 142007, Russia
Irkutsk Regional Center for the Prevention and Control of AIDS and Infections /ID# 229509
Irkutsk, 664035, Russia
Specialized Clinical Infectious Diseases Hospital /ID# 229814
Krasnodar, 350000, Russia
Infectious Clinical Hosp #1 /ID# 225063
Moscow, 125310, Russia
Infectious Clinical Hospita l#2 /ID# 243217
Nizhny Novgorod, 603022, Russia
S. P. Botkin City Hospital /ID# 229510
Oryol, 302038, Russia
Saint-Petersburg AIDS Center /ID# 239357
Saint Petersburg, 190103, Russia
Samara Region Clinical HIV/AIDS Prevention and Control Center /ID# 226591
Samara, 443029, Russia
Stavropol State Medical University /ID# 243216
Stavropol, 355017, Russia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2020
First Posted
October 8, 2020
Study Start
October 7, 2020
Primary Completion
September 3, 2022
Study Completion
September 3, 2022
Last Updated
August 14, 2023
Record last verified: 2023-08