Clinical trials: Direct Acting Antiviral Agents
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
Lung Diseases
Transplanting Hepatitis C Lungs Into Negative Lung Recipients
This study is being conducted to determine safety and effectiveness of transplanting lungs from Hepatitis C-positive donors into Hepatitis C-negative patients on the lung transplant waitlist, who will then be treated with…
- Trial name
- SHELTER (NCT03724149)
- Testing
- Zepatier, Epclusa
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Pennsylvania
Chronic Hepatitis C Infection
Switching Regimen in Treating Cirrhotic HCV GT1b Subjects
This is a prospective, randomized study to evaluate the efficacy and safety of switching treatment from Peg-interferon and Ribavirin to direct-acting antiviral agents in Chinese with CHC genotype 1b infection, who are…
- Trial name
- SWITCH-1 (NCT02583685)
- Testing
- PR4 + LDV/SOF + ASV 4 wk, PR4 + LDV/SOF + SMV 4 wk, PR4 + LDV/SOF + ASV 6 wk
- Where
- 2 sites in China
- Volunteers
- 138 people
- Sponsor
- Humanity and Health Research Centre
Pharmacological Action
Safety and Efficacy of Gratisovir (Sofosbuvir)- Ribavirin Therapy in Pediatric Patients
Evaluation of Safety and Efficacy of Gratisovir (Sofosbuvir)- Ribavirin Therapy in Egyptian Pediatric Patients With Chronic Hepatitis C Infection aged 10- 18 years old.
- Trial name
- NCT02985281
- Testing
- Sofosbuvir Oral Product, Ribavirin
- Where
- Egypt
- Volunteers
- 41 people
- Sponsor
- National Liver Institute, Egypt
HIV-1 Infection, Hepatitis C
12 Weeks of Ledipasvir (LDV)/Sofosbuvir (SOF) With Weight-based Ribavirin vs. 24 Weeks of LDV/SOF
People who are infected with Hepatitis C Virus (HCV) have a great chance of being cured of the infection when they are treated with sofosbuvir.
- Trial name
- NCT02605304
- Testing
- Ledipasvir/sofosbuvir, Ribavirin
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Hepatitis C, Chronic
Observational Study in HCV Chronic Infection
HCV infection is the most frequent cause of liver chronic disease, cirrhosis and hepatocellular carcinoma in western countries. To date, the standard antiviral treatment, including pegylated interferon (PEG-IFN) plus ribavirin…
- Trial name
- NCT01945008
- Where
- Italy
- Volunteers
- 7,600 people
- Sponsor
- Istituto Superiore di Sanità
End Stage Renal Disease
Transplanting Hepatitis C Kidneys Into Negative Kidney Recipients
This study is being conducted to determine safety and effectiveness of transplanting kidneys from Hepatitis C-positive donors into Hepatitis C-negative patients on the kidney transplant waitlist, who will then be treated with the…
- Trial name
- THINKER (NCT02743897)
- Testing
- Zepatier, Mavyret
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- University of Pennsylvania
Hepatitis C Virus Infection
Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen
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…
- Trial name
- NCT02822794
- Testing
- SOF/VEL, RBV
- Where
- 18 sites in Japan
- Volunteers
- 117 people
- Sponsor
- Gilead Sciences
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 Infection
Triple DAAs Regimen in Treating Non-cirrhotic HCV GT1b Subjects
The study is designed to test the hypothesis that the addition of a protease inhibitor to dual NS5a-NS5B nucleoside prodrug analog will enhance antiviral efficacy and hence shorten the treatment duration to 3 weeks.
- Trial name
- NCT02470858
- Testing
- LDV/SOF+ASV, SOF+DCV+SMV, SOF+DCV+ASV
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Humanity and Health Research Centre
Depression in Chronic Hepatitis C
Effects of Direct-acting Antiviral Agents on HCV Cognitive Function, and Depression in HCV Related Cirrhosis: A Prospective Clinical Trial
Minimal hepatic encephalopathy (MHE) is an important clinical variant of hepatic encephalopathy (HE), which occurs in up to 60-70% of patients with cirrhosis.
- Trial name
- NCT04330508
- Testing
- Depression and Cognitive Tests
- Where
- India
- Volunteers
- 385 people, healthy volunteers welcome
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Chronic Hepatitis C, Hepatitis C Virus
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-493 and ABT-530 With and Without Ribavirin in Adults With HCV Who Failed a Prior DAA Containing Therapy
The purpose of this study is to assess the efficacy and safety of ABT-493 and ABT-530 with or without ribavirin (RBV) in participants with chronic hepatitis C virus, (HCV)-infection who previously failed treatment with a direct…
- Conditions
- Chronic Hepatitis C, Hepatitis C Virus, HCV, Direct-Acting Antiviral Agent (DAA)-Experienced
- Trial name
- NCT02446717
- Testing
- ABT-493, ABT-530, ribavirin (RBV), ABT-493/ABT-530
- Volunteers
- 141 people
- Sponsor
- AbbVie
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
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
Hepatocellular Carcinoma, Hepatitis C
Direct-acting Antivirals and Hepatocellular Carcinoma Recurrence
Background and Aims: Arrival of direct-acting antiviral (DAA) agents against hepatitis C virus (HCV) with high-sustained virological response (SVR) rates and very few side effects has drastically changed the management of HCV…
- Conditions
- Hepatocellular Carcinoma, Hepatitis C, Direct Acting Antivirals
- Trial name
- RECAR (NCT03197155)
- Testing
- Direct Acting Antivirals against hepatitis C virus infection
- Volunteers
- 68 people
- Sponsor
- Hospices Civils de Lyon
Diabetes Mellitus, Hepatitis C, Chronic
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Background: Chronic hepatitis C infects the liver. It may scar the liver. This is called cirrhosis and may lead to liver cancer or death. Current chronic hepatitis C treatments cure most people.
- Conditions
- Diabetes Mellitus, Hepatitis C, Chronic, Cardiovascular Diseases
- Trial name
- NCT03520660
- Testing
- Epclusa
- Where
- United States
- Volunteers
- 121 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Hepatitis C, Chronic
GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Chronic Genotype 1 Hepatitis C Virus
This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy with GS-5885 Alone or in Combination with GS-9451 with Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects with…
- Trial name
- NCT01356160
- Testing
- GS-5885, GS-9451, peginterferon alfa-2a
- Where
- 23 sites in United States, Australia and 1 more
- Volunteers
- 351 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis C
The Relationship Between MDSCs and NK Cells Activity of CHC Patient Treated by DAAs
Hepatitis C virus (HCV) infection is easy to chronic and can progress to cirrhosis and liver cancer. Direct-acting antiviral treatment can significantly improve the prognosis of the disease and the efficacy is seemingly not…
- Trial name
- NCT03188276
- Testing
- Ledipasvir-Sofosbuvir, Daclatasvir-Sofosbuvir
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
Antiviral Drug Adverse Reaction
Effect Of DAAs For Treatment Of HCV On Normal Kidney
The aim of the study is to determine the effect of different direct acting antiviral drugs used for treatment of chronic HCV infected patients on normal kidney.
- Trial name
- NCT03296930
- Testing
- Sofosbuvir 400 MG Oral Tablet,, Ombitasvir/paritaprevir/ritonavir
- Volunteers
- 100 people
- Sponsor
- Assiut University
Hepatitis C, HIV
Study of A Combination Pill With GS-7977 and GS-5885 for Hepatitis C in People With HIV
Background: Present treatment for hepatitis C includes the use of a weekly injection and two different pills. This treatment is associated with serious side effects.
- Trial name
- NCT01878799
- Testing
- GS-7977/GS- 5885 FDC
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)