Clinical trials: Direct Acting Antiviral Agents
Hepatitis C, Chronic
Oral Antivirals (GS-5885, Tegobuvir, and/or GS-9451) With Peginterferon Alfa 2a and Ribavirin in Treatment Experienced Subjects With Chronic Genotype 1 Hepatitis C Virus Infection
This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy using Combinations of Oral Antivirals (GS-5885, tegobuvir, and/or GS-9451) with Peginterferon Alfa 2a and Ribavirin in…
- Trial name
- NCT01371578
- Testing
- GS-5885 tablet, GS-9451 tablet, peginterferon alfa-2a
- Where
- 55 sites in United States, Puerto Rico
- Volunteers
- 163 people
- Sponsor
- Gilead Sciences
Hepatitis C
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy
The primary objectives of this study are to evaluate the safety and efficacy of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C virus (HCV) infection who have previously…
- Trial name
- POLARIS-1 (NCT02607735)
- Testing
- SOF/VEL/VOX
- Where
- 86 sites in United States, Australia and 6 more
- Volunteers
- 416 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis C
Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION)
This study was to assess the safety and efficacy of sofosbuvir in combination with ribavirin (RBV) administered for 12 or 16 weeks in participants with genotypes 2 or 3 hepatitis C virus (HCV) infection as assessed by the…
- Trial name
- FUSION (NCT01604850)
- Testing
- SOF, RBV
- Where
- 67 sites in United States, Canada and 2 more
- Volunteers
- 202 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus Infection
Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor
The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of…
- Trial name
- POLARIS-4 (NCT02639247)
- Testing
- SOF/VEL/VOX, SOF/VEL
- Where
- 78 sites in United States, Australia and 6 more
- Volunteers
- 333 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis C
Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies
This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults with chronic hepatitis C virus (HCV)…
- Trial name
- NCT01625338
- Testing
- SOF, RBV, Peg-IFN
- Where
- 175 sites in United States, Australia and 14 more
- Volunteers
- 534 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus
The Durability of Response and Persistence of Resistance to AbbVie's 2 Direct-acting Antiviral Agent (2D) Therapy in Japanese Subjects
This study seeks to assess the durability of response and persistence of resistance to ombitasvir/ paritaprevir/ritonavir in Japanese participants who enrolled in a Phase 2 or 3 clinical study with these agents for the treatment…
- Trial name
- NCT02581020
- Where
- 53 sites in Japan
- Volunteers
- 344 people
- Sponsor
- AbbVie
Chronic Hepatitis C Virus
Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV), administered for 8 or 12 weeks of treatment in…
- Trial name
- NCT01726517
- Testing
- LDV/SOF, RBV
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic
An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens
This observational long-term follow-up study will assess the persistence of direct acting antiviral (DAA) resistant mutations and the durability of sustained virological response in patients with chronic hepatitis C who have…
- Trial name
- NCT01168856
- Where
- 126 sites in United States, Australia and 13 more
- Volunteers
- 734 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C
Sofosbuvir (GS-7977) in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3
This study is to evaluate the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF) in combination with peginterferon alfa 2a (PEG) and ribavirin (RBV) administered for 12 weeks in participants with chronic genotype 2…
- Trial name
- NCT01808248
- Testing
- SOF, PEG, RBV
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus Infection
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Participants Undergoing Cancer Chemotherapy
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) in treating hepatitis C virus (HCV) infection in pediatric participants who are undergoing cancer…
- Trial name
- NCT02868242
- Testing
- LDV/SOF
- Where
- Egypt
- Volunteers
- 19 people
- Sponsor
- Gilead Sciences
Chronic Genotype 1a or 1b HCV Infection
GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection
This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects…
- Trial name
- NCT01434498
- Testing
- GS-5885 tablet, GS-9451 tablet, tegobuvir capsule
- Where
- 50 sites in United States, Canada and 1 more
- Volunteers
- 163 people
- Sponsor
- Gilead Sciences
Hepatitis C
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir and Sofosbuvir/Velpatasvir in Adults With Chronic HCV Infection Who Have Not Previously Received Treatment With Direct-Acting Antiviral Therapy
The primary objectives of this study are to compare the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) for 8 weeks with that of SOF/VEL FDC for…
- Trial name
- POLARIS-2 (NCT02607800)
- Testing
- SOF/VEL/VOX, SOF/VEL
- Where
- 93 sites in United States, Australia and 6 more
- Volunteers
- 943 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis C
A Study to Evaluate the Safety and Effect of Treatment With Experimental Antiviral Drugs in Combination With Peginterferon Alpha-2a and Ribavirin in People With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie/Abbott Combination Study
A study to evaluate the safety and effect of treatment with experimental antiviral drugs in combination with peginterferon alpha-2a and ribavirin in people with hepatitis C virus who did not respond to treatment in a previous…
- Trial name
- NCT01609933
- Testing
- ABT-450/r, ABT-267, pegylated interferon alpha-2a (pegIFN)
- Volunteers
- 32 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Hepatitis C, Chronic
GS-5885, GS-9451, Tegobuvir and Ribovirin in Treatment-Experienced Subjects With Chronic Genotype 1a Or 1b Hepatitis C Virus (HCV) Infection
This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) Compared with GS-5885, GS-9451 with Tegobuvir or RBV in Treatment-Experienced Subjects with Chronic Genotype…
- Trial name
- NCT01435226
- Testing
- GS-5885, GS-9451, tegobuvir
- Where
- 51 sites in United States, Germany
- Volunteers
- 170 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus Infection
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
This Registry will enroll adolescent and pediatric participants who received at least one Gilead Hepatitis C Virus (HCV) direct acting antiviral (DAA) while participating in a Gilead-sponsored chronic hepatitis C clinical trial.
- Trial name
- NCT02510300
- Testing
- Sofosbuvir (SOF), Ledipasvir/Sofosbuvir (LDV/SOF), Sofosbuvir/Velpatasvir (SOF/VEL)
- Where
- 51 sites in United States, Australia and 7 more
- Volunteers
- 461 people
- Sponsor
- Gilead Sciences
Hepatitis C
UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis
To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin in treatment naive cirrhotic subjects.
- Trial name
- NCT01973049
- Testing
- Daclatasvir, Asunaprevir, BMS-791325
- Where
- 49 sites in United States, Australia and 2 more
- Volunteers
- 202 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C
A Study to Assess Resistance and Durability of Response to ABT-493 and/or ABT-530
This was a long-term follow-up study to evaluate the durability of sustained virologic response (SVR), persistence of direct-acting antiviral agent (DAA) resistance, and clinical outcomes for participants who received glecaprevir…
- Trial name
- NCT02441283
- Testing
- ABT-493, ABT-530
- Where
- 42 sites in United States, Australia and 6 more
- Volunteers
- 384 people
- Sponsor
- AbbVie
Chronic Hepatitis C
Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection
This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with hepatitis C virus (HCV) genotypes 1, 4, 5 …
- Trial name
- NEUTRINO (NCT01641640)
- Testing
- Sofosbuvir, RBV, PEG
- Where
- 56 sites in United States, Puerto Rico
- Volunteers
- 328 people
- Sponsor
- Gilead Sciences
Chronic HCV Infection
Ledipasvir/Sofosbuvir Fixed-Dose Combination With Ribavirin or GS-9669 in Subjects With Chronic Genotype 1 HCV Infection
This study will evaluate the antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) or LDV/SOF plus GS-9669 in treatment-naive or treatment-experienced participants with chronic…
- Trial name
- NCT01984294
- Testing
- LDV/SOF, RBV, GS-9669
- Where
- United States
- Volunteers
- 101 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection
This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) plus ribavirin (RBV) in treatment-naive adults with chronic genotype 3 hepatitis C virus…
- Trial name
- NCT02413593
- Testing
- LDV/SOF, RBV
- Where
- 15 sites in Canada
- Volunteers
- 111 people
- Sponsor
- Gilead Sciences