Status:
COMPLETED
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
Lead Sponsor:
AbbVie
Conditions:
Hepatitis C Virus (HCV)
Eligibility:
All Genders
12+ years
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 ci...
Eligibility Criteria
Inclusion
- 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
- Participating or intending to participate in a concurrent interventional therapeutic trial.
Key Trial Info
Start Date :
May 29 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 11 2021
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT04352309
Start Date
May 29 2020
End Date
June 11 2021
Last Update
June 9 2022
Active Locations (6)
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1
South Ural State Medical University /ID# 225501
Chelyabinsk, Russia, 454052
2
Irkutsk Regional Center for the Prevention and Control of AIDS and Infections /ID# 225499
Irkutsk, Russia, 664035
3
S. P. Botkin City Hospital /ID# 225500
Oryol, Russia, 302038
4
Samara Region Clinical HIV/AIDS Prevention and Control Center /ID# 222582
Samara, Russia, 443029