EASY: 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

Sponsor

AbbVie (Industry)

Overall Status

Completed

CT.gov ID

NCT04352309

Collaborator

(none)

Enrollment

Locations

12.4

Actual Duration (Months)

16.5

Patients Per Site

1.3

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) 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.

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

Study Design

Study Type:

Observational

Actual Enrollment :

99 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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)

Actual Study Start Date :

May 29, 2020

Actual Primary Completion Date :

Jun 11, 2021

Actual Study Completion Date :

Jun 11, 2021

Arms and Interventions

Arm	Intervention/Treatment
Participants Treated With Glecaprevir/Pibrentasvir (GLE/PIB) Participants will receive GLE/PIB over 8 weeks of therapy as prescribed by their physicians.

Outcome Measures

Primary Outcome Measures

Percentage Of Participants Achieving Sustained Virologic Response At 12 Weeks (SVR12) [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.

Secondary Outcome Measures

Number Of Participants Achieving SVR12 After Last Actual Dose Of GLE/PIB At 12 Weeks In Subgroups Of Interest [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.
Number Of Participants With Co-morbidities [At Week 20]
Participants who have other existing medical conditions.
Number Of Participants Taking Concomitant Medication [At Week 20]
Participants who take other medications along with Glecaprevir/Pibrentasvir (GLE/PIB).
Percentage Of GLE/PIB Dose Taken In Relation To The Prescribed Target Dose [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).
Number of Participants With Adverse Events [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.
Percentage of Participants With Shifts in Clinical Laboratory Values [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.
Number Of Health Care Resource Utilization (HCRU) Over Time Overall And By Subpopulations Of Interest [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	South Ural State Medical University /ID# 225501	Chelyabinsk	Russian Federation	454052
2	Irkutsk Regional Center for the Prevention and Control of AIDS and Infections /ID# 225499	Irkutsk	Russian Federation	664035
3	S. P. Botkin City Hospital /ID# 225500	Oryol	Russian Federation	302038
4	Samara Region Clinical HIV/AIDS Prevention and Control Center /ID# 222582	Samara	Russian Federation	443029
5	Stavropol State Medical University /ID# 226589	Stavropol	Russian Federation	355017
6	Medical center Academy /ID# 226587	Ulyanovsk	Russian Federation	432063