Hepatitis C Clinical Trial
Official title:
Open Label Phase II/III, Multicenter, Trial to Assess the Efficacy, Safety, Tolerance, and Pharmacokinetics of Sofosbuvir Plus Ravidasvir in HCV (+/- HIV) Chronically Infected Adults With no or Compensated Cirrhosis in Thailand and Malaysia
This is a Phase II/III, multicenter, multi-country, trial to assess the efficacy, safety, tolerance and pharmacokinetics of sofosbuvir plus ravidasvir for the treatment of HCV infection.
This is a Phase II/III, multicenter, multi-country trial to assess the efficacy, safety, tolerance and pharmacokinetics of SOF-RDV for the treatment of HCV infection, across genotypes 1,2,3,6, among non-cirrhotic and cirrhotic with CTP class A, interferon/ribavirin naïve or experienced, HCV mono-infected and HCV/HIV co-infected subjects. It will also study the pharmacokinetics of RDV and, in HCV/HIV co-infected subjects, possible drug-drug interactions with antiretrovirals. The treatment duration will be 12 weeks for subjects with no cirrhosis (Metavir F0 to F3) and 24 weeks for subjects with compensated cirrhosis (Metavir F4, CTP class A). The study is performed in 2 stages. Stage 1 has been completed. Efficacy and safety results from Stage 1 were reviewed and approved by the independent Data and Safety Monitoring Board (DSMB) which provided the recommendation to proceed with the study stage 2. On-going stage 2 aims to supplement Stage 1 results and provide additional information on the performance of SOF-RDV in the main genotypes found in Malaysia and Thailand. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
|
Phase 1 | |
| Recruiting |
NCT04510246 -
Link Hepatitis C Notifications to Treatment in Tasmania
|
N/A | |
| Completed |
NCT03413696 -
Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
|
||
| Completed |
NCT03109457 -
Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma
|
||
| Completed |
NCT03118674 -
Harvoni Treatment Porphyria Cutanea Tarda
|
Phase 2 | |
| Completed |
NCT01458054 -
Effect of Omeprazole and Ritonavir on GSK2336805 Pharmacokinetics in Healthy Adults
|
Phase 1 | |
| Completed |
NCT03740230 -
An Observational Study of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the Standard for Re-examination of New Drugs
|
||
| Completed |
NCT03426787 -
Helping Empower Liver and Kidney Patients
|
N/A | |
| Completed |
NCT03627299 -
Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors
|
Phase 4 | |
| Completed |
NCT00006301 -
Immune Response to Hepatitis C Virus
|
||
| Active, not recruiting |
NCT03949764 -
The Kentucky Viral Hepatitis Treatment Study
|
Phase 4 | |
| Completed |
NCT03365635 -
Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C
|
Phase 4 | |
| Recruiting |
NCT04405024 -
Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients
|
N/A | |
| Completed |
NCT04525690 -
Improving Inpatient Screening for Hepatitis C
|
N/A | |
| Completed |
NCT04033887 -
Evaluation Study of RDTs Detecting Antibodies Against HCV
|
||
| Withdrawn |
NCT04546802 -
HepATocellular Cancer Hcv Therapy Study
|
Phase 3 | |
| Completed |
NCT02869776 -
Integrating HCV and HIV Screening During the Era of HIV Antigen Testing
|
N/A | |
| Completed |
NCT02683005 -
Study of Hepatitis C Treatment During Pregnancy
|
Phase 1 | |
| Completed |
NCT03186313 -
A Study to Evaluate the Safety and Efficacy of the Combined Single Dose of Dactavira Plus Or Dactavira in Egyptian Adults With Chronic Genotype 4 HCV Infection
|
Phase 3 | |
| Completed |
NCT02705534 -
Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1
|
Phase 3 |