Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis
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|ClinicalTrials.gov Identifier: NCT04112303|
Recruitment Status : Active, not recruiting
First Posted : October 2, 2019
Last Update Posted : October 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Virus Infection||Drug: SOF/VEL||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3 Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic HCV Infection and Compensated Cirrhosis|
|Actual Study Start Date :||October 16, 2019|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||June 2021|
Participants will receive SOF/VEL for up to 12 weeks.
400/100 mg tablets administered orally once daily
- Proportion of Participants with Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Treatment [ Time Frame: Posttreatment Week 12 ]SVR12 is defined as HCV RNA < LLOQ at 12 weeks after stopping study treatment.
- Percentage of Participants Experiencing any Treatment-Emergent Adverse Event Leading to Discontinuation of Study Drug [ Time Frame: Up to the end of Treatment plus 30 days ]
- Proportion of Participants with HCV RNA < LLOQ at 4 Weeks After Discontinuation of Treatment (SVR4) [ Time Frame: Posttreatment Week 4 ]
- Proportion of Participants with HCV RNA < LLOQ at 24 Weeks After Discontinuation of Treatment (SVR24) [ Time Frame: Posttreatment Week 24 ]
- Proportion of Participants with Virologic Failure [ Time Frame: First date dose up to posttreatment Week 24 ]
Virologic failure is defined as:
On-treatment virologic failure:
- Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
- Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
- Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
- Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on treatment visit.
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): NCT04112303
|Study Director:||Gilead Study Director||Gilead Sciences|