Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02822794
Other study ID # GS-US-342-3921
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 25, 2016
Est. completion date August 25, 2017

Study information

Verified date July 2018
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and ribavirin (RBV) in participants with chronic genotype 1 or 2 hepatitis C virus (HCV) infection who have previously failed a direct-acting antiviral (DAA)-containing regimen.


Recruitment information / eligibility

Status Completed
Enrollment 117
Est. completion date August 25, 2017
Est. primary completion date June 2, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Key Inclusion Criteria:

- Genotype 1 or 2 HCV infection

- Chronic HCV infection (= 6 months prior to screening) documented by prior medical history or liver biopsy

- Previously treated with a DAA-containing regimen of at least 4 week duration

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design


Intervention

Drug:
SOF/VEL
400/100 mg tablet administered orally once daily
RBV
Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (= 60 kg = 600 mg, > 60 kg to = 80 kg = 800 mg, and = 80 kg = 1000 mg)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. Posttreatment Week 12
Primary Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event Up to 24 weeks
Secondary Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. Posttreatment Week 4
Secondary Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. Posttreatment Week 24
Secondary Percentage of Participants With HCV RNA < LLOQ at Week 1 Week 1
Secondary Percentage of Participants With HCV RNA < LLOQ at Week 2 Week 2
Secondary Percentage of Participants With HCV RNA < LLOQ at Week 3 Week 3
Secondary Percentage of Participants With HCV RNA < LLOQ at Week 4 Week 4
Secondary Percentage of Participants With HCV RNA < LLOQ at Week 5 Week 5
Secondary Percentage of Participants With HCV RNA < LLOQ at Week 6 Week 6
Secondary Percentage of Participants With HCV RNA < LLOQ at Week 8 Week 8
Secondary Percentage of Participants With HCV RNA < LLOQ at Week 10 Week 10
Secondary Percentage of Participants With HCV RNA < LLOQ at Week 12 Week 12
Secondary Percentage of Participants With HCV RNA < LLOQ at Week 16 Week 16
Secondary Percentage of Participants With HCV RNA < LLOQ at Week 20 Week 20
Secondary Percentage of Participants With HCV RNA < LLOQ at Week 24 Week 24
Secondary Change From Baseline in HCV RNA at Week 1 Baseline; Week 1
Secondary Change From Baseline in HCV RNA at Week 2 Baseline; Week 2
Secondary Change From Baseline in HCV RNA at Week 3 Baseline; Week 3
Secondary Change From Baseline in HCV RNA at Week 4 Baseline; Week 4
Secondary Change From Baseline in HCV RNA at Week 5 Baseline; Week 5
Secondary Change From Baseline in HCV RNA at Week 6 Baseline; Week 6
Secondary Change From Baseline in HCV RNA at Week 8 Baseline; Week 8
Secondary Change From Baseline in HCV RNA at Week 10 Baseline; Week 10
Secondary Change From Baseline in HCV RNA at Week 12 Baseline; Week 12
Secondary Change From Baseline in HCV RNA at Week 16 Baseline; Week 16
Secondary Change From Baseline in HCV RNA at Week 20 Baseline; Week 20
Secondary Change From Baseline in HCV RNA at Week 24 Baseline; Week 24
Secondary Percentage of Participants With Overall Virologic Failure Virologic failure was 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)
Virologic relapse:
Confirmed HCV RNA = LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Up to Posttreatment Week 24
See also
  Status Clinical Trial Phase
Completed NCT02487030 - Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection Phase 3
Active, not recruiting NCT05460130 - Implementing HCV Treatment for High-risk Populations in Austin, Texas N/A
Completed NCT02220998 - Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Adults With Chronic Genotype 2 HCV Infection Phase 3
Terminated NCT01052090 - Safety and Efficacy Study in Hepatitis C Patients With PHN121 Phase 1/Phase 2
Completed NCT02537379 - Use-Results Surveillance Study of Sovaldi® Plus Copegus® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection N/A
Recruiting NCT04156945 - Interventions to Curb Hepatitis C Reinfections Among Men Who Have Sex With Men N/A
Terminated NCT02510300 - A Registry for Adolescent and Pediatric Participants Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead-Sponsored Chronic Hepatitis C Infection Trials
Withdrawn NCT04309734 - Study of AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects Phase 1/Phase 2
Active, not recruiting NCT04001608 - Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 1 Hepatitis C Virus Infection Patients Phase 3
Completed NCT04112303 - 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 Phase 3
Completed NCT02251717 - Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection Phase 2
Recruiting NCT05092074 - Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) for Patients With Hepatitis C Virus Infection
Recruiting NCT04005248 - Prevalence of HCV in HIV-negative MSM N/A
Completed NCT02249182 - Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection Phase 2
Completed NCT02939989 - 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 Phase 3
Completed NCT01718145 - A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects Phase 3
Completed NCT01482611 - A Study in Healthy Participants Investigating the Safety, Tolerability and Plasma Pharmacokinetics (PK) of Single Oral Doses of JNJ-47910382 Phase 1
Completed NCT00255177 - Antiviral Activity and Safety of 3 Different Doses of Mifepristone in Hepatitis C Infected Patients Phase 2
Terminated NCT02600351 - Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies Phase 3
Completed NCT04980157 - CARES-HCV: Promoting Screening Uptake Among Diverse Baby Boomers