Clinical trial NCT04577482: Study of Oral Glecaprevir/Pibrentasvir Tablets in Participants Aged 12 Years or Older With Chronic Hepatitis C to Assess Sustained Virological Response
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C Virus (HCV)
Keywords: Hepatitis C Virus (HCV)
Chronic Hepatitis C Infection
Glecaprevir/pibrentasvir
GLE/PIB
CHOICE
Chronic Hepatitis C Genotype 1
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-10-08
Enrollment: 42
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: Participants with hepatitis C virus (HCV) infection of genotype 1 prescribed with glecaprevir/pibrentasvir in accordance with local clinical practice and 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), 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Achieving Sustained Virological Response (SVR) at Week 12 (SVR12)
timeFrame: Week 12 after the end of treatment
Secondary outcomes:
measure: Percentage of Participants Achieving SVR12
timeFrame: Week 12 after the end of treatment
measure: Number of Participants With Co-morbidities and Taking Concomitant Medication
timeFrame: Up to Week 12 after the end of treatment
measure: Health Care Resource Utilization (HCRU)
timeFrame: Up to Week 12 after the end of treatment
measure: Percent of Glecaprevir/Pibrentasvir Dose Taken by Participant Report in Relation to the Prescribed Target Dose
timeFrame: Up to Week 12 after the end of treatment
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to Week 12 after the end of treatment
measure: Percentage of Participants Who Experienced Post-Baseline Shifts in Clinical Laboratory Values
timeFrame: Up to Week 12 after the end of treatment
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: South Ural State Medical University /ID# 226555
city: Domodedovo
country: Russian Federation
facility: LLC Center of Targeted Therapy /ID# 239529
city: Irkutsk
country: Russian Federation
facility: Irkutsk Regional Center for the Prevention and Control of AIDS and Infections /ID# 229509
city: Krasnodar
country: Russian Federation
facility: Specialized Clinical Infectious Diseases Hospital /ID# 229814
city: Moscow
country: Russian Federation
facility: Infectious Clinical Hosp #1 /ID# 225063
city: Nizhniy Novgorod
country: Russian Federation
facility: Infectious Clinical Hospita l#2 /ID# 243217
city: Oryol
country: Russian Federation
facility: S. P. Botkin City Hospital /ID# 229510
city: Samara
country: Russian Federation
facility: Samara Region Clinical HIV/AIDS Prevention and Control Center /ID# 226591
city: St. Petersburg
country: Russian Federation
facility: Saint-Petersburg AIDS Center /ID# 239357
city: Stavropol
country: Russian Federation
facility: Stavropol State Medical University /ID# 243216
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: