Clinical trial NCT03868163: Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C in the Russian Federation
Official title: Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6 in Russian Federation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C (CHC)
Keywords: Chronic Hepatitis C
Hepatitis C
Hepatitis
glecaprevir
pibrentasvir
real world setting
Observational Study
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-03-08
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CHC in a real world clinical practice setting.

Brief summary: This study seeks to assess the effectiveness of Glecaprevir plus Pibrentasvir in participants with chronic hepatitis C in a real-life setting across clinical practice populations in the Russian Federation.


Eligibility criteria: Inclusion Criteria:

* Treatment-naïve or - pegIFN (or IFN), and/or Ribavirin (RBV) and/or sofosbuvir (PRS) experienced with confirmed CHC, genotypes 1, 2, 3, 4, 5, or 6, with or without compensated cirrhosis, receiving combination therapy with the all oral GLE/PIB regimen according to standard of care, international guidelines and in line with the current local label.
* May be enrolled up to 4 weeks after treatment initiation.
* Patients must voluntarily sign and date Informed Consent Form prior to inclusion into the study,
* Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
timeFrame: Up to approximately 28 weeks
Secondary outcomes:
measure: Percentage of Participants Achieving SVR12 by Mono HCV or co-infected HCV/HIV Status
timeFrame: Up to approximately 28 weeks
measure: Percentage of Participants Achieving SVR12 by CHC Genotype
timeFrame: Up to approximately 28 weeks
measure: Percentage of Participants Achieving SVR12 by Cirrhosis Status
timeFrame: Up to approximately 28 weeks
measure: Percentage of Participants Achieving SVR12 by Previous Treatment Experience
timeFrame: Up to approximately 28 weeks
measure: Percentage of Participants Achieving SVR12 by Patients Who Use Drugs
timeFrame: Up to approximately 28 weeks
measure: Percentage of Elderly Participants Achieving SVR12
timeFrame: Up to approximately 28 weeks
measure: Percentage of Patients with Commodities
timeFrame: Up to approximately 16 weeks
measure: Percentage of Participants Taking Concomitant Medications
timeFrame: Up to approximately 28 weeks
measure: Percentage of GLE/PIB Dose Taken
timeFrame: Up to approximately 16 weeks
measure: Number of Health Care Resource Utilization (HCRU)
timeFrame: Up to approximately 28 weeks
Other outcomes:
Locations:
city: Samara
country: Russian Federation
facility: LLC Medical Company Hepatolog /ID# 212384
state: Samarskaya Oblast
city: Stavropol
country: Russian Federation
facility: Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 217035
state: Stavropol Skiy Kray
city: Kazan
country: Russian Federation
facility: A. F. Agafonov Republican Clin /ID# 212381
state: Tatarstan, Respublika
city: Chelyabinsk
country: Russian Federation
facility: South Ural State Medical univ /ID# 212020
city: Novosibirsk
country: Russian Federation
facility: Clinical Inf. Dis Hospital 1 /ID# 217033
city: Oryol
country: Russian Federation
facility: SIH Orlovskiy region city hospital named after S.P. Botkin /ID# 212383
city: Perm
country: Russian Federation
facility: Perm Regional Center of Cepato /ID# 213992
city: Samara
country: Russian Federation
facility: Samara State Medical Universit /ID# 217029
city: St. Petersburg
country: Russian Federation
facility: Saint-Petersburg AIDS Center /ID# 212380
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: