Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/Velpatasvir
NCT03818308 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2021-07-06
Summary
This is a single arm multicenter pilot study to evaluate the efficacy and safety of treatment with sofosbuvir (SOF)/velpatasvir (VEL) fix dose combination (FDC) in patients with acute hepatitis C virus (HCV) infection.
Conditions
- Hepatitis C
- Acute Hepatitis C
Interventions
- DRUG
-
Sofosbuvir and Velpatasvir
All subjects will receive one film-coated tablet of sofosbuvir/velpatasvir (400/100 mg) orally once daily for 8 weeks.
Sponsors & Collaborators
-
HepNet Study House, German Liverfoundation
collaborator NETWORK - collaborator INDUSTRY
-
German Center for Infection Research
collaborator OTHER -
Hannover Medical School
lead OTHER
Principal Investigators
-
Markus Cornberg, Prof. Dr. · Hannover Medical School, Clinic for Gastroenterology, Hepatology, and Endocrinology
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-05-28
- Primary Completion
- 2021-06-08
- Completion
- 2021-06-08
Countries
- Germany
Study Locations
More Related Trials
-
Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Adults With Chronic Genotype 3 HCV Infection
NCT02201953 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection
NCT02480712 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Participants With Chronic Genotype 3 HCV Infection and Cirrhosis
NCT02781558 ·Status: COMPLETED ·Phase: PHASE2
-
Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection
NCT02346721 ·Status: COMPLETED ·Phase: PHASE3
-
HepNet Acute HCV IV - LDV/SOF FDC in Acute Genotype 1 Hepatitis C Virus Infection
NCT02309918 ·Status: COMPLETED ·Phase: PHASE2
-
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
NCT02607800 ·Status: COMPLETED ·Phase: PHASE3
-
Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Adults Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
NCT03118843 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of SOF/VEL/VOX FDC for 8 Weeks and SOF/VEL for 12 Weeks in Adults Chronic Genotype 3 HCV Infection and Cirrhosis
NCT02639338 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection
NCT04211909 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy
NCT02607735 ·Status: COMPLETED ·Phase: PHASE3
-
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
NCT02822794 ·Status: COMPLETED ·Phase: PHASE3
-
Sofosbuvir/Velpatasvir Fixed Dose Combination in Participants With Chronic Hepatitis C Virus Infection Who Have Received a Liver Transplant
NCT02781571 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis
NCT02996682 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection
NCT03022981 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection
NCT01858766 ·Status: COMPLETED ·Phase: PHASE2
-
Combined Ribavirin With Sofosbuvir/Velpatasvir/Voxilaprevir in Retreatment of Chronic Hepatitis C Non-responders
NCT04695769 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV Infection
NCT02378961 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Investigate Pharmacokinetics, Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) Fixed Dose Combination (FDC) in Adolescents and Children With Chronic Hepatitis C Virus (HCV) Infection
NCT03820258 ·Status: TERMINATED ·Phase: PHASE2
-
Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis
NCT02201901 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Adults With Chronic Genotype 2 HCV Infection
NCT02220998 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection
NCT01909804 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Velpatasvir in Participants With Chronic HCV Infection
NCT01740791 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Voxilaprevir in Adults With Chronic Hepatitis C Virus Infection
NCT02185794 ·Status: COMPLETED ·Phase: PHASE1
-
Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease
NCT03036852 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study
NCT02300103 ·Status: COMPLETED ·Phase: PHASE2