Status:
COMPLETED
Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C in the Russian Federation
Lead Sponsor:
AbbVie
Conditions:
Chronic Hepatitis C (CHC)
Eligibility:
All Genders
18+ years
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 Federa...
Eligibility Criteria
Inclusion
- 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
- None.
Key Trial Info
Start Date :
February 28 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 4 2020
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT03868163
Start Date
February 28 2019
End Date
September 4 2020
Last Update
August 30 2021
Active Locations (9)
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1
LLC Medical Company Hepatolog /ID# 212384
Samara, Samara Oblast, Russia, 443063
2
Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 217035
Stavropol, Stavropol Kray, Russia, 355035
3
A. F. Agafonov Republican Clin /ID# 212381
Kazan', Tatarstan, Respublika, Russia, 420140
4
South Ural State Medical univ /ID# 212020
Chelyabinsk, Russia, 454052