Clinical trials: Direct Acting Antiviral Agents
Hepatitis C, Public Health
HCV RAS Testing in Public Health Programs
Successful treatment of hepatitis C has been reported to be associated with 62-84% reduction in all-cause mortality (deaths), 68-79% reduction in risk of HCC and 90% reduction in risk of liver transplantation.
- Conditions
- Hepatitis C, Public Health, Direct Acting Antiviral Agents, Resistance Associated Substitutions
- Trial name
- RAS-HCV (NCT04242433)
- Testing
- Direct Acting Antivirals
- Where
- 2 sites in India
- Volunteers
- 200 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
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
Hepatocellular Carcinoma
Epigenetic Changes in Hepatocellular Carcinoma Developed After Direct Acting Antiviral Therapy for Chronic Hepatitis C
Hepatocellular carcinoma (HCC) is the most common type of liver cancer, its survival rate ranks only second to lung cancer and it is a severe threat to human health. In Egypt, HCC constitutes a significant public health problem.
- Trial name
- NCT04220151
- Testing
- DNA methylation
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Assiut University
Healthy
The Effects of the Direct Acting Antiviral Agent Boceprevir on the Pharmacokinetics of Maraviroc in Healthy Volunteers
Infection by both HIV and hepatitis C virus (HCV)is frequent due to similar transmission modes. Near 20% of people living with HIV are also infected by HCV.
- Trial name
- NCT01627717
- Testing
- Maraviroc (5 days), Maraviroc and boceprevir (14 days)
- Where
- Canada
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
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
Hepatocellular Carcinoma
DAA in the Risk of Recurrence After Curative Treatment of HCC
For early stage of HCC, surgical resection or radiofrequency ablation (RFA) is the mainstay curative treatments. However, recurrence is still a major issue after the surgery or RFA.
- Trial name
- NCT02959359
- Testing
- Ledipasvir 90mg/Sofosbuvir 400 mg, Ribavirin
- Sponsor
- Taipei Veterans General Hospital, Taiwan
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
Hepatitis C
Effect of Direct-acting Antiviral Drugs on Erectile Function
Effect of direct-acting antiviral drugs on erectile function
- Trial name
- NCT03444272
- Testing
- Sofosbuvir and Daklatasuvir
- Where
- Egypt
- Volunteers
- 105 people
- Sponsor
- Sherief Abd-Elsalam
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
Carcinoma, Hepatocellular, Hepatitis C Virus Infection, Response to Therapy of
Possible Differences in HCC Course Depending on DAA Treatment
BACKGROUND It is estimated that around 71 milion people live with chronic hepatitis C virus (HCV) infection. This may lead to the development of liver cirrhosis and hepatocellular carcinoma (HCC).
- Conditions
- Carcinoma, Hepatocellular, Hepatitis C Virus Infection, Response to Therapy of, Drug Effect, Drug Side Effect
- Trial name
- NCT05376943
- Testing
- Direct Acting Antivirals
- Where
- Poland
- Volunteers
- 100 people
- Sponsor
- Medical University of Warsaw
Egyptian Patients, HCV Treatment, Kidney Function
The Renal Safety in Patients With Chronic HCV Undergoing Sofosbuvir Containing Antiviral Therapy
The aim of this study is to investigate the occurrence of AKI during antiviral therapy, when compared with baseline values in Egyptian patients.
- Trial name
- NCT04169464
- Testing
- Sofosbuvir Oral Product
- Where
- Egypt
- Volunteers
- 200 people
- Sponsor
- MTI University
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
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
Pulmonary Artery Hypertension, Chronic Hepatitis c
Pulmonary Arterial Hypertension in Patients With Direct-Acting Antiviral Medications for Hepatitis C Virus Infection
The purpose of this study is the evaluation of PAH in patients, who are treated with DAA medication for HCV infection.
- Trial name
- NCT04094272
- Testing
- transthoracic doppler-echocardiography (TTE)
- Where
- Switzerland
- Volunteers
- 49 people
- Sponsor
- Kantonsspital Olten
Drug-Induced Liver Injury
Immune Responses in Hepatocellular Carcinoma Patients After Treatment With Direct Acting Antiviral Drugs
Case control Study to assess the difference of immune cell responses between patients with chronic HCV- related liver cirrhosis who develop HCC after treatment with DAAs and those who do not develop HCC
- Trial name
- NCT03602703
- Testing
- Flow cytometry and Western Blot analysis
- Where
- Egypt
- Volunteers
- 42 people
- Sponsor
- Assiut University
Respiratory Failure, Hepatitis C
Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Lung Transplant
This is a proof of concept, single center study for the donation of HCV-positive lungs to HCV negative recipient patients, with preemptive, interventional treatment with 8 weeks of commercially available DAA therapy to prevent…
- Trial name
- NCT03625687
- Testing
- Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 8 weeks
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Massachusetts General Hospital
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, Mixed Cryoglobulinemia
Benefit of DAA Therapy in HCV Monoinfected and HIV-HCV Coinfected Patients With Mixed Cryoglobulinemia
Mixed cryoglobulinemia (MC) is common in patients with chronic hepatitis C virus (HCV) infection. Direct-acting antiviral (DAA) regimens are today very effective with sustained virological response rates (SVR12) above 90%.
- Trial name
- NCT03342261
- Testing
- DAA treatment
- Where
- France
- Volunteers
- 47 people
- Sponsor
- Hospices Civils de Lyon
HCV Recurrence, Liver Transplantation
Use of Direct-acting Antiviral to Treat HCV Recurrence After Liver Transplantation (ANRSCO23CUPILT) Infection
The purpose of this study is to evaluate the efficacy, safety and tolerability of direct-acting antivirals therapy in liver transplanted patients who experienced HCV recurrence.
- Conditions
- HCV Recurrence, Liver Transplantation, Direct-acting Antiviral Agents
- Trial name
- ANRSCO23CUPILT (NCT01944527)
- Where
- France
- Volunteers
- 699 people
- Sponsor
- ANRS, Emerging Infectious Diseases
Patternsof Liver Diseasesadmissions After Era of DAAS
Difference in Patterns of Liver Diseases Related Admissions After the Era of DAAS
Liver disease accounts for approximately 2 million deaths per year worldwide, 1 million due to complications of cirrhosis and 1 million due to viral hepatitis and hepatocellular carcinoma Hepatitis is defined as inflammation of…
- Trial name
- NCT05284916
- Testing
- liver diseases admissions
- Volunteers
- 200 people
- Sponsor
- Sohag University