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NCT02939989 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study
A Phase 3 study of Hepatitis C Virus Infection, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 33
- Enrollment target
- 20
- Study locations
NCT02939989: Completed Phase 3 study of Hepatitis C Virus Infection, sponsored by AbbVie.
NCT02939989 is a Phase 3 study of Hepatitis C Virus Infection that has completed, run by AbbVie. The registered enrollment target is 33 participants, below the 196-participant average among 5 other Hepatitis C Virus Infection trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02939989, a Phase 3 study of Hepatitis C Virus Infection, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 33 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study was to evaluate the efficacy and safety of co-administration of glecaprevir (ABT-493)/pibrentasvir (ABT 530) plus sofosbuvir (SOF) plus ribavirin (RBV) in hepatitis C virus (HCV) genotype (GT) 1 - 6-infected participants (including non-cirrhotic, or cirrhotic with compensated cirrhosis participants) who had experienced virologic failure in an AbbVie parent clinical study.
Primary Outcome
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug.
Conditions Studied
Interventions
- DRUG Ribavirin
- DRUG Sofosbuvir
- DRUG Glecaprevir/Pibrentasvir
Study Locations (20)
Other
- Beijing Di Tan Hospital, Capital Medical University /ID# 218496 - Beijing
- West China Hospital, Sichuan University /ID# 217613 - Chengdu
- The First Hospital Affiliated to AMU (Southwest Hospital) /ID# 218494 - Chongqing
- Mengchao Hepatobiliary Hospital of Fujian Medical University /ID# 218495 - Fuzhou
- Asklepios Klinik St. Georg /ID# 155733 - Hamburg
Alabama
- Digestive Health Specialists of the Southeast /ID# 155719 - Dothan
California
- Ruane Clinical Research Group /ID# 155714 - Los Angeles
Maryland
- Digestive Disease Associates - Baltimore /ID# 155713 - Baltimore
Michigan
- Henry Ford Health System /ID# 155720 - Detroit
New York
- University of Buffalo /ID# 155721 - Buffalo
North Carolina
- Carolinas Center For Liver Dis /ID# 155731 - Statesville
Tennessee
- Gastro One /ID# 155729 - Germantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2016-11-21 |
| Est. Completion | 2021-07-30 |
| Phase | Phase 3 |
What the finished NCT02939989 record still lists
NCT02939989 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 196-participant average among 5 other Hepatitis C Virus Infection trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Hepatitis C Virus Infection appearing as the primary indexed condition, and to 3 interventions - of which Ribavirin is the first listed.
NCT02939989 names 20 study sites across 16 states, led by Other, Alabama, California.
Frequently Asked Questions
What is clinical trial NCT02939989 about?
NCT02939989 is a clinical study titled "Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study". The purpose of this study was to evaluate the efficacy and safety of co-administration of glecaprevir (ABT-493)/pibrentasvir (ABT 530) plus sofosbuvir (SOF) plus ribavirin (RBV) in hepatitis C virus (HCV) genotype (GT) 1 - 6-infected participants (including non-cirrhotic, or cirrhotic with compensat...
What is the current status of trial NCT02939989?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 33 participants. The study started on 2016-11-21. Estimated completion is 2021-07-30.
What conditions does trial NCT02939989 study?
This clinical trial studies the following conditions: Hepatitis C Virus Infection.
What interventions are being tested in trial NCT02939989?
The interventions under investigation include: Ribavirin (DRUG), Sofosbuvir (DRUG), Glecaprevir/Pibrentasvir (DRUG).
Who is sponsoring clinical trial NCT02939989?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02939989 being conducted?
This trial has 20 study locations across Alabama, California, Maryland, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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