Clinical trials: Flaviviridae Infections
Hepatitis, Hepatitis C
Efficacy and Safety of Grazoprevir (+) Uprifosbuvir (+) Ruzasvir (MK-3682B) (MK-5172 + MK-3682 + MK-8408) Fixed Dose Combination in Chronic HCV Participants Failing Prior Antiviral Treatment (MK-3682-021)
This is a randomized, multicenter, 2-part, open-label trial of the combination regimen of grazoprevir (GZR [MK-5172]; 100mg), uprifosbuvir (UPR [MK-3682]; 450 mg) and ruzasvir (RZR [MK-8408]; 60 mg) with and without Ribavirin…
- Conditions
- Hepatitis, Hepatitis C, Digestive System Diseases, Flaviviridae Infections
- Trial name
- NCT02613403
- Testing
- MK-3682B, Ribavirin
- Volunteers
- 94 people
- Sponsor
- Merck Sharp & Dohme LLC
Viral Infection
Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects
The objective is to evaluate the safety and tolerability of a single-ascending oral dose of UV-4B in healthy subjects and to determine pharmacokinetic parameters describing absorption and elimination following a single dose of…
- Trial name
- UV (NCT02061358)
- Testing
- UV-4B 3 mg, UV-4B 10 mg, UV-4B 30 mg
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Viral Infection
Safety and Pharmacokinetics of UV-4B Solution Administered Orally as Multiple Ascending Doses to Healthy Subjects
The purpose of this study is to evaluate the safety and pharmacokinetics of UV-4B oral solution when administered to healthy subjects three times a day (TID) for 7 days.
- Trial name
- NCT02696291
- Testing
- UV-4B 30 mg oral solution, UV-4B 75 mg oral solution, UV-4B 150 mg oral solution
- Where
- 2 sites in United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Hepatitis C Virus Infection
Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Voxilaprevir in Adults With Chronic Hepatitis C Virus Infection
The primary objective of the study is to evaluate the safety and tolerability of voxilaprevir (formerly GS-9857) alone or with sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) and antiviral activity of voxilaprevir…
- Trial name
- NCT02185794
- Testing
- Voxilaprevir, SOF/VEL
- Where
- 11 sites in United States, Puerto Rico
- Volunteers
- 101 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis C, Hepatitis C
Study of AT-527 in Healthy and HCV-Infected Subjects
This study has multiple parts. It will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 in healthy subjects and subjects infected with hepatitis C virus (HCV).
- Conditions
- Chronic Hepatitis C, Hepatitis C, Hepatitis C, Chronic
- Trial name
- NCT03219957
- Testing
- AT-527
- Where
- 2 sites in Belgium, Moldova
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Atea Pharmaceuticals, Inc.
Chronic Hepatitis C Virus
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV
The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks…
- Trial name
- NCT01701401
- Testing
- LDV/SOF, RBV
- Where
- 88 sites in United States, France and 5 more
- Volunteers
- 870 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 Virus
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin for the Treatment of HCV (ION-3)
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 in treatment-naive…
- Trial name
- NCT01851330
- Testing
- LDV/SOF, RBV
- Where
- 52 sites in United States
- Volunteers
- 647 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
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
Post-transplant Hepatitis C
Expanded Access Program of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon in Aggressive Post-transplant Hepatitis C
This is a single arm, open-label study which will be opened at specific clinical sites at the request of an investigator for the treatment of individual subjects for whom there are no other treatment options.
- Trial name
- NCT01779518
- Testing
- Sofosbuvir, Ribavirin, Pegylated Interferon
- Sponsor
- Gilead Sciences
Hepatitis C
Study of Safety, Tolerability, and Anti-Viral Effect of Locteron Compared to PEG-Intron in Patients With Chronic Hepatitis C
The purposes of the PLUS study were to confirm the safety and tolerability of two doses of LocteronTM (320 ug and 640 ug) dosed over four weeks in patients who had failed prior anti-HCV therapies (Panels A and B), and then to…
- Trial name
- PLUS (NCT00593151)
- Testing
- Locteron (controlled-release interferon alpha 2b), pegylated IFNa2b
- Where
- 5 sites in United States
- Volunteers
- 32 people
- Sponsor
- Biolex Therapeutics, Inc.