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

Hepatitis C Virus (HCV) Clinical Trial

— EASY  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04352309
• Other study ID #: P20-276
• Status: Completed
• Start date: May 29, 2020
• Est. completion date: June 11, 2021

Study information

• Verified date: June 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: June 11, 2021
• Est. primary completion date: June 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus (HCV)
• Hepatitis C, Chronic
• Liver Cirrhosis

Locations

Country	Name	City	State
Russian Federation	South Ural State Medical University /ID# 225501	Chelyabinsk
Russian Federation	Irkutsk Regional Center for the Prevention and Control of AIDS and Infections /ID# 225499	Irkutsk
Russian Federation	S. P. Botkin City Hospital /ID# 225500	Oryol
Russian Federation	Samara Region Clinical HIV/AIDS Prevention and Control Center /ID# 222582	Samara
Russian Federation	Stavropol State Medical University /ID# 226589	Stavropol
Russian Federation	Medical center Academy /ID# 226587	Ulyanovsk

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Russian Federation, 

Outcome

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

External Links

•   clinical study report synopsis