Clinical trials: Direct Acting Antiviral Agents
Intestinal Microbiota Between Different Groups
Impact of Direct-acting Antiviral Drugs on The Patterns of Gut Microbiota in Patients With HCV Related Chronic Liver Diseases
The recent introduction of direct-acting antiviral (DAA) therapy has dramatically changed the rates of cure of HCV infection even in difficult to treat subjects and in those with severe comorbidities .
- Trial name
- NCT06829966
- Where
- Egypt
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Assiut University
Hepatitis C, HIV
Control and Elimination Within Australia of Hepatitis C From People Living With HIV
The purpose of this study is to evaluate the feasibility of rapid scale-up of new hepatitis C (HCV) treatments, known as interferon-free Direct Acting Antiviral (DAA) drugs, and impact on the proportion of people with HCV within…
- Conditions
- Hepatitis C, HIV, HIV-HCV Coinfection
- Trial name
- CEASE (NCT02102451)
- Where
- 18 sites in Australia
- Volunteers
- 492 people
- Sponsor
- Kirby Institute
Viral Hepatitis C, Therapy Adverse Effect
Autoantibodies and Direct-acting Antivirals
The investigators assessed non-organ-specific antibodies before and 24 weeks after the end of therapy with direct-acting antivirals, in order to better clarify the clinical relevance of these antibodies in terms of treatment…
- Trial name
- BIOEPA (NCT03566966)
- Testing
- Non-organ-specific Ab positive, Non-organ-specific Ab negative
- Where
- Italy
- Volunteers
- 191 people
- Sponsor
- University of Bari
HCC
Risk of HCC in Cirrhotic Patients Post DAAs Ttt
Direct acting antivirals (DAAs) are a novel and completely oral hepatitis C therapy . DAAs are used in most patients being treated for hepatitis C, including those with decompensated cirrhosis.
- Trial name
- NCT03414554
- Volunteers
- 100 people
- Sponsor
- Assiut University
Chronic Hepatitis c
Assessment Effects After Direct Acting Antiviral in Chronic Hepatitis c Virus Patients
Chronic hepatitis C virus infection affects an estimated one hundred and seventy million people around the world with and approximate prevalence 0.2-2 % in the United State of America and European countries.
- Trial name
- NCT03163849
- Testing
- Sofosbuvir , daclatasvir
- Where
- 2 sites in Egypt
- Volunteers
- 50 people
- Sponsor
- Assiut University
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, Alcohol Use Disorder
HCV and Co-morbid Alcohol Use Disorders: A Translational Investigation of Antiviral Therapy Outcomes on CNS Function
The primary objective of this research project is to compare neuropsychiatric functioning, cortical activity, white matter integrity, and immune response among Veterans with and without alcohol use disorder (AUD), before and…
- Trial name
- NCT03902366
- Testing
- Neuropsychological assessment, Neuroimaging
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Hepatitis C, Chronic
DAA Based Therapy for Recently Acquired Hepatitis C (DARE-C)
To examine the safety and efficacy of response guided triple therapy (PEG-IFN, Ribavirin, Telaprevir) for the treatment of early chronic Hepatitis C Virus (HCV) infection.
- Trial name
- DARE-C (NCT01743521)
- Testing
- TPV/PEG-IFN/RBV
- Where
- 2 sites in Australia
- Volunteers
- 14 people
- Sponsor
- Kirby Institute
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
Investigate the Renal Effect of DAAs on Egyption Patients After Completion of Treatment
Prevalence of Kidney Injury in Patients With HCV Treated With Sofuspovir Containing DAA Therapy
this study aims is to investigate the occurrence of AKI during antiviral therapy, defined as an increase of 0.3 mg/dL or 50% at least in serum creatinine level when compared with baseline values or more than a 25% reduction in…
- Trial name
- NCT04267458
- Testing
- evaluation of sofuspovir containing DAA regien expected insult on kidney
- Where
- Egypt
- Volunteers
- 300 people
- Sponsor
- Cairo University
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
Hepatitis C, Chronic
Simplifying HCV Treatment in Rwanda for Elsewhere in the Developing World: Pangenotypic and Retreatment Study (SHARED3)
The main purpose of the study is to determine the antiviral efficacy and evaluate the safety and tolerability of sofosbuvir/ velpatasvir (SOF/VEL) and sofosbuvir/ velpatasvir/ voxilaprevir (SOF/VEL/VOX) used to treat individuals…
- Trial name
- SHARED3 (NCT03888729)
- Testing
- sofosbubir/velpatasvir, sofosbubir/velpatasvir/voxilaprevir
- Where
- Rwanda
- Volunteers
- 100 people
- Sponsor
- Partners in Health
Hepatitis C, Chronic
Combination Therapy for Chronic Hepatitis C Infection
Background: GS-7977, GS-5885, GS-9669, and GS-9451 are new drugs for treating hepatitis C virus (HCV) infection. GS-7977 may help treat the infection when used with other treatments like interferon therapy.
- Trial name
- NCT01805882
- Testing
- Sofosbuvir, Ledipasvir, GS-9669
- Where
- 3 sites in United States
- Volunteers
- 229 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hepatitis C, Hepatocellular Carcinoma
Direct Acting Antiviral-Post Authorization Safety Study
This is an independent optional sub-study parallel to TARGET-HCC (NCT02954094). The purpose of Direct-Acting Antiviral-Post Authorization Safety Study (DAA-PASS) is to investigate the impact of exposure to direct-acting…
- Trial name
- NCT03707080
- Where
- 62 sites in United States, France and 3 more
- Volunteers
- 42 people
- Sponsor
- Target PharmaSolutions, Inc.
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
Occult HCV Infection After DAAD Treatment in Haemodialysis Patients
This research aims to evaluate the prevalence and predictors of Occult HCV among hemodialysis (HD) patients who achieved 24 weeks sustained virological response (SVR) after treatment with direct-acting antiviral agents (DAA) by…
- Trial name
- NCT04719338
- Testing
- presence of HCV RNA in peripheral blood mononuclear cells (PBMCs) .
- Where
- Egypt
- Volunteers
- 30 people
- Sponsor
- Alexandria University
HCV
Impact of Metabolic Changes and Vitamin D Status on Virological Response in Patients With HCV Infection Treated by DAAs
1. Study Changes in lipid profile and the impact of Insulin resistance on virological response in patients with Hepatitis C viral infection treated by Direct Acting Antiviral agents 2.
- Trial name
- NCT03820102
- Volunteers
- 100 people
- Sponsor
- Assiut University
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
Beta-Thalassemia, Hepatitis C
Hyalornic Acid Level in β-Thalassemic Children Treated for Hepatitis C Virus
Patients with transfusion dependent Beta Thalassemia suffer from a high incidence of Hepatitis C infection especially in developed countries as Egypt.
- Trial name
- NCT03961828
- Testing
- Ledipasvir 90 MG / Sofosbuvir 400 MG [Harvoni]
- Where
- Egypt
- Volunteers
- 50 people
- Sponsor
- Tanta University