HBV Clinical Trial
Official title:
Safety and Efficacy of Tenofovir Alafenamide for Chronic Hepatitis B Patients With Decompensated Liver Disease
TAF is a new prodrug of tenofovir, specifically designed to achieve higher intracellular active drug concentration allowing for dosing of only 25 mg once daily and thus can potentially lower the already relatively low risk of renal toxicity and bone loss with TDF. However, such renal and bone complications with TDF may become more pronounced in decompensated CHB patients10. In the phase 3 trials11, 12, TAF had demonstrated a compatible antiviral effect (noninferior efficacy), and a higher rate of alanine aminotransferase (ALT) normalization to TDF. TAF also demonstrated an improved renal function and less bone loss compared to TDF. Therefore, TAF was approved as the first line therapy for CHB patients with compensated liver function. The lack of data regarding TAF therapy in decompensated CHB patients raised the concern of safety and efficacy of TAF in this group of patients. A small, single arm Phase 2 switch study (GS-US-320-4035; Study 4035; NCT03180619) which has enrolled 31 subjects with CPT scores ≥7, either at time of screening or by history, who were virally suppressed on TDF and/or other oral antiviral agents is currently underway with favorable safety and efficacy results through 48 weeks.[Lim YS, Lin CY, Heo J, et al. EASL 2020, poster SAT442.] While Gilead Study 4035 will continue through 96 weeks of treatment, additional data in this population are thus needed, particularly in CHB patients who have decompensated liver disease and are not being treated and are viremic. Herein, we conduct the present study and aim to investigate the safety and efficacy of TAF in CHB patients with hepatic decompensation.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05442437 -
Clinical Study of hUC-MSCs Treating Decompensated Liver Cirrhosis With HBV
|
Early Phase 1 | |
| Completed |
NCT04519710 -
Specific Anti-HBV Vaccine Response After Vaccination in Patients Requiring Anti-CD20 Monoclonal Antibodies
|
N/A | |
| Recruiting |
NCT04562051 -
Stratified vs Routine Prophylaxis in Living Kidney Transplantation From HBsAg+ Donors to HBsAg- Recipients
|
||
| Active, not recruiting |
NCT02344680 -
Liver Fibrosis in Zambian HIV-HBV Co-infected Patients
|
||
| Completed |
NCT02044068 -
Hepatitis B Virus Vertical Transmission From HIV-HBV Co-infected Women
|
N/A | |
| Completed |
NCT03239353 -
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Entecavir Extended Release (XR) in Healthy Subjects
|
Phase 1 | |
| Recruiting |
NCT04904835 -
Access HBV Assays - European Union (EU) Clinical Trial Protocol -
|
||
| Terminated |
NCT04059198 -
Evaluating the Safety and Efficacy of Inarigivir in Non-cirrhotic Treatment Naive Subjects Infected With Hepatitis B Virus
|
Phase 2 | |
| Not yet recruiting |
NCT05293158 -
Impact of Hepatitis B Immunoglobulins in Patients With Chronic Hepatitis B on Hepatocellular Carcinoma - a Proof of Concept Study
|
N/A | |
| Not yet recruiting |
NCT05028322 -
Evaluation of Intradermal Hepatitis B Vaccine After IMIQUIMOD's Application, in Cirrhotics Who Did Not Respond to the Usual Vaccine Regimen
|
Phase 2 | |
| Not yet recruiting |
NCT01556815 -
Sorafenib Combined With Transarterial Chemoembolization in Treating HBV-infected Patients With Intermediate Hepatocellular Carcinoma
|
Phase 2 | |
| Completed |
NCT02312531 -
Prevention for Mother-to-infant Transmission of HBV
|
N/A | |
| Recruiting |
NCT05786859 -
The Efficacy and Safety of Rifaximin Treatment
|
Early Phase 1 | |
| Recruiting |
NCT05951751 -
The TRIple Elimination Model Of Mother-to-child Transmission Program (TRI-MOM)
|
N/A | |
| Not yet recruiting |
NCT06307808 -
Viral Immunity in Solid Organ Transplant Recipients: Monitoring Of The Response To Hepatitis B Booster Vaccination
|
||
| Completed |
NCT03149627 -
Chronic Hepatitis B Virus Clinical Epidemiology in a Representative Sample of Zambian Adults
|
||
| Recruiting |
NCT04886336 -
The Impact of Tenofovir Alafenamide on Profiles of Body Weight and Metabolic Features in Chronic Hepatitis B Patients.
|
||
| Recruiting |
NCT04568265 -
A Clinical Study of APG-1387 in Combination With Entecavir in Patients With Chronic Hepatitis B
|
Phase 2 | |
| Terminated |
NCT02826018 -
A Study of ALN-HBV in Healthy Adult Volunteers and Non-cirrhotic Patients With Chronic Hepatitis B Virus (HBV) Infection
|
Phase 1 | |
| Completed |
NCT01970254 -
Widespread vs. Selective Screening for Hepatitis B Infection Prior to Chemotherapy
|