Clinical trial NCT04352309: 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
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C Virus (HCV)
Keywords: HCV, Hepatitis C Virus
Hepatitis C
Liver Cirrhosis
GLE/PIB
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-04-20
Enrollment: 99
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage Of Participants Achieving Sustained Virologic Response At 12 Weeks (SVR12)
timeFrame: At Week 20
Secondary outcomes:
measure: Number Of Participants Achieving SVR12 After Last Actual Dose Of GLE/PIB At 12 Weeks In Subgroups Of Interest
timeFrame: At Week 20
measure: Number Of Participants With Co-morbidities
timeFrame: At Week 20
measure: Number Of Participants Taking Concomitant Medication
timeFrame: At Week 20
measure: Percentage Of GLE/PIB Dose Taken In Relation To The Prescribed Target Dose
timeFrame: At Week 20
measure: Number of Participants With Adverse Events
timeFrame: Baseline (Week 0) To 30 days post last dose
measure: Percentage of Participants With Shifts in Clinical Laboratory Values
timeFrame: Baseline (Week 0) to Week 20
measure: Number Of Health Care Resource Utilization (HCRU) Over Time Overall And By Subpopulations Of Interest
timeFrame: At Week 20
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: South Ural State Medical University /ID# 225501
city: Irkutsk
country: Russian Federation
facility: Irkutsk Regional Center for the Prevention and Control of AIDS and Infections /ID# 225499
city: Oryol
country: Russian Federation
facility: S. P. Botkin City Hospital /ID# 225500
city: Samara
country: Russian Federation
facility: Samara Region Clinical HIV/AIDS Prevention and Control Center /ID# 222582
city: Stavropol
country: Russian Federation
facility: Stavropol State Medical University /ID# 226589
city: Ulyanovsk
country: Russian Federation
facility: Medical center Academy /ID# 226587
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: