Trials / Completed
CompletedNCT02939989
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
An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Combination With Sofosbuvir and Ribavirin in Chronic Hepatitis C (HCV) Infected Subjects Who Have Experienced Virologic Failure in AbbVie HCV Clinical Studies (MAGELLAN-3)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 12 Years – 99 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This study enrolled HCV infected adults who had experienced virologic failure following treatment with glecaprevir/pibrentasvir or paritaprevir/ritonavir/ombitasvir + dasabuvir (DSV) (3D) or paritaprevir/ritonavir/ombitasvir (2D) regimens in one of the following AbbVie hepatitis C virus parent studies: * M13-594 (NCT02640157) * M13-596 (NCT02692703) * M14-172 (NCT02642432) * M14-242 (NCT02493855) * M14-868 (NCT02243293) * M15-410 (NCT02446717) * M15-592 (NCT03222583) * M16-126 (NCT02966795) * M16-135 (NCT03089944)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sofosbuvir | Tablet for oral administration |
| DRUG | Glecaprevir/Pibrentasvir | Coformulated tablet for oral administration |
| DRUG | Ribavirin | Tablet for oral administration |
Timeline
- Start date
- 2016-11-21
- Primary completion
- 2021-05-07
- Completion
- 2021-07-30
- First posted
- 2016-10-20
- Last updated
- 2022-05-04
- Results posted
- 2022-05-04
Locations
26 sites across 12 countries: United States, Australia, Canada, China, Germany, New Zealand, Russia, South Korea, Spain, Sweden, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02939989. Inclusion in this directory is not an endorsement.