Clinical trials: Direct Acting Antiviral Agents
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
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
Sofosbuvir + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon
This multicenter study was to evaluate subjects with chronic genotype 2 or 3 HCV infection who were interferon (IFN) ineligible, IFN intolerant or unwilling to take IFN.
- Trial name
- POSITRON (NCT01542788)
- Testing
- SOF, RBV
- Where
- 63 sites in United States, Australia and 3 more
- Volunteers
- 278 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic
An Observational Study of Peginterferon (e.g. Pegasys)-Based Direct Acting Antiviral Triple Therapy in Patients With Chronic Hepatitis C Genotype 1
This prospective observational study will evaluate the efficacy and safety of two approved pegylated interferon-based direct acting antiviral triple therapies in patients with chronic hepatitis C genotype 1.
- Trial name
- NCT01508130
- Where
- 66 sites in United States, Puerto Rico
- Volunteers
- 672 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C, Chronic
Gilead Sustained Virologic Response (SVR) Registry
This Registry is designed to provide long term clinical and virologic follow up in participants who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored hepatitis C virus (HCV)…
- Trial name
- NCT01457755
- Where
- 325 sites in United States, Australia and 15 more
- Volunteers
- 6,625 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic
A Gilead Sequence Registry of Subjects Who Did Not Achieve Sustained Virologic Response
This Registry is designed to obtain long term data on participants who have failed to achieve sustained virologic response (SVR) while receiving at least one Gilead oral antiviral agent (OAV) in a previous Gilead-sponsored…
- Trial name
- NCT01457768
- Where
- 323 sites in United States, Australia and 14 more
- Volunteers
- 570 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
Healthy
Study to Investigate the Pharmacokinetic Interaction Between 2 Direct Acting Antiviral Agents Odalasvir and AL-335 and Between 3 Direct Acting Antiviral Agents Simeprevir, Odalasvir and AL-335 at Steady State in Healthy Japanese Participants
The purpose of this study is to investigate the steady-state pharmacokinetics (PK) of simeprevir (SMV), odalasvir (ODV) and AL-335 (and its metabolites ALS-022399 and ALS 022227), when these drugs are co-administered in healthy…
- Trial name
- NCT02824315
- Testing
- AL-335, Odalasvir (ODV), Simeprevir (SMV)
- Where
- United Kingdom
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Hepatitis C
UNITY 1: A Study of an Investigational Treatment Regimen of Daclatasvir (DCV) + Asunaprevir (ASV) + BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) for 12 Weeks for the Treatment of Chronic Hepatitis C Virus (HCV) Genotype 1 Infection in Non-cirrhotic Subjects
To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and treatment experienced non-cirrhotic subjects
- Trial name
- NCT01979939
- Testing
- DCV/ASV/BMS-791325
- Where
- 66 sites in United States, Australia and 3 more
- Volunteers
- 416 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C
3-Year Observational Virology Follow-up Study in Subjects Who Participated in Studies of Idenix Anti-HCV, Direct Acting Antivirals
All subjects in this study have previously been in an Idenix HCV study and received study drug for 3 consecutive days. Subjects who had received placebo in a previous Idenix study will not be enrolled in this study.
- Trial name
- NCT01721265
- Volunteers
- 145 people
- Sponsor
- Merck Sharp & Dohme LLC
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
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 Virus Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in adults with chronic…
- Trial name
- NCT02472886
- Testing
- LDV/SOF, RBV
- Where
- 20 sites in Estonia, Russia
- Volunteers
- 153 people
- Sponsor
- Gilead Sciences
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 Hepatitis C Virus
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir fixed dose combination (FDC) with or without ribavirin (RBV) administered for 12 or 24 weeks in treatment-experienced subjects…
- Trial name
- ION-2 (NCT01768286)
- Testing
- LDV/SOF, RBV
- Where
- 53 sites in United States
- Volunteers
- 441 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
A Follow up Study Designed to Obtain Long Term Data on Participants Who Either Achieved a Sustained Virologic Response or Did Not Achieve a Sustained Virologic Response in an AbbVie Sponsored Hepatitis C Study
A follow-up study to assess resistance and durability of response to 3 experimental drugs ABT-450/r, ABT-267, and ABT-333 in participants who have participated in AbbVie Phase 2 or 3 clinical studies with these agents for the…
- Trial name
- NCT01773070
- Testing
- ABT-450/ritonavir, ABT-333, ABT-267
- Volunteers
- 478 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Hepatitis C, Chronic
GS 5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) in Chronic Genotype 1 Hepatitis C Virus (HCV) Infection
The purpose of this phase 2 study is to determine whether 30 mg or 90 mg of GS-5885 when given with GS-9451, Tegobuvir and Ribavirin (RBV) for 12 or 24 weeks is effective, safe and tolerable in the treatment of Chronic Genotype 1…
- Trial name
- NCT01353248
- Testing
- GS-5885, Tegobuvir, GS-9451
- Where
- 43 sites in United States, Puerto Rico
- Volunteers
- 141 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus
Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection
This study is to to evaluate the safety, tolerability, and efficacy of sofosbuvir (SOF) plus ribavirin (RBV) in Egyptian adults with genotype 4 hepatitis C virus (HCV) infection.
- Trial name
- NCT01838590
- Testing
- SOF, RBV
- Where
- 2 sites in Egypt
- Volunteers
- 103 people
- Sponsor
- Gilead Sciences