Sofosbuvir/Velpatasvir Fixed-Dose Combination in HCV-Infected Adults Who Are Undergoing Liver Transplantation
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|ClinicalTrials.gov Identifier: NCT02728206|
Recruitment Status : Completed
First Posted : April 5, 2016
Results First Posted : February 6, 2019
Last Update Posted : February 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Virus Infection||Drug: SOF/VEL||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir Fixed Dose Combination Administered for Four Weeks in Patients Infected With Chronic HCV in the Peri-Operative Liver Transplantation Setting|
|Actual Study Start Date :||June 12, 2016|
|Actual Primary Completion Date :||January 16, 2018|
|Actual Study Completion Date :||January 16, 2018|
SOF/VEL FDC for 4 weeks starting on the day of or day after the participant's liver transplant
400/100 mg FDC tablet administered orally once daily
- Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
- Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [ Time Frame: Up to Week 4 ]
- Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) [ Time Frame: Posttreatment Week 4 ]SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
- Percentage of Participants With HCV RNA < LLOQ On Treatment [ Time Frame: Days 3, 5, 7, 14, 21, and 28 ]
- Percentage of Participants With Overall Virologic Failure [ Time Frame: Up to Posttreatment Week 12 ]Virologic failure was defined as 1) End of Treatment Virologic Failure: HCV RNA ≥ 15 IU/mL at last observed HCV RNA measurement on or prior to last dose date of SOF/VEL + 3 days after completion of 28 ± 3 days of SOF/VEL treatment, or 2) Relapse: HCV RNA ≥ 15 IU/mL during the posttreatment follow-up period having achieved HCV RNA < 15 IU/mL at the end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728206
|Auckland, New Zealand|
|Study Director:||Gilead Study Director||Gilead Sciences|