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

Hepatitis C Virus (HCV) Clinical Trial

— CHOICE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04577482
• Other study ID #: P20-397
• Status: Completed
• Start date: October 7, 2020
• Est. completion date: September 3, 2022

Study information

• Verified date: August 2023
• 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), 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 3, 2022
• Est. primary completion date: September 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus (HCV)
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
Russian Federation	South Ural State Medical University /ID# 226555	Chelyabinsk
Russian Federation	LLC Center of Targeted Therapy /ID# 239529	Domodedovo
Russian Federation	Irkutsk Regional Center for the Prevention and Control of AIDS and Infections /ID# 229509	Irkutsk
Russian Federation	Specialized Clinical Infectious Diseases Hospital /ID# 229814	Krasnodar
Russian Federation	Infectious Clinical Hosp #1 /ID# 225063	Moscow
Russian Federation	Infectious Clinical Hospita l#2 /ID# 243217	Nizhniy Novgorod
Russian Federation	S. P. Botkin City Hospital /ID# 229510	Oryol
Russian Federation	Samara Region Clinical HIV/AIDS Prevention and Control Center /ID# 226591	Samara
Russian Federation	Saint-Petersburg AIDS Center /ID# 239357	St. Petersburg
Russian Federation	Stavropol State Medical University /ID# 243216	Stavropol

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 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	Percentage of Participants Achieving SVR12	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.	Week 12 after the end of treatment
Secondary	Number of Participants With Co-morbidities and Taking Concomitant Medication	Number of participants with co-morbidities and taking concomitant medication of interest report will be calculated.	Up to Week 12 after the end of treatment
Secondary	Health Care Resource Utilization (HCRU)	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.	Up to Week 12 after the end of treatment
Secondary	Percent of Glecaprevir/Pibrentasvir 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 will be calculated.	Up to Week 12 after the end of treatment
Secondary	Number of Participants With Adverse Events (AEs)	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.	Up to Week 12 after the end of treatment
Secondary	Percentage of Participants Who Experienced Post-Baseline Shifts in Clinical Laboratory Values	Percentage of participants who experience post-baseline shifts during treatment in clinical laboratory values will be summarized overall and in subgroups of interest.	Up to Week 12 after the end of treatment

External Links

•   clinical study report synopsis