Hepatitis B, Chronic Clinical Trial
Official title:
A Prospective, Multi-center, Cohort Study to Evaluate the Efficacy and Safety of Tenofovir Alafenamide (TAF) for Prevention of Mother-to-child Transmission of Hepatitis B Virus Among Pregnant Women With High Level HBV DNA
The purpose of this study is to evaluate the efficacy and safety of Tenofovir alafenamide (TAF) for prevention of mother-to-child transmission of hepatitis B virus among pregnant women with high level HBV DNA.
This is a single-arm multicenter, prospective, clinical study, aiming to evaluate the efficacy and safety of Tenofovir alafenamide (TAF) for prevention of mother-to-child transmission of hepatitis B virus among pregnant women with high level HBV DNA. 330 HBV-infected mothers with high level HBV DNA will be enrolled and receive Tenofovir alafenamide (TAF) for prevention of mother-to-child transmission of HBV. Demographic data, antiviral treatment history, pregnancy and labour history, co-morbidity, HBV serologic marker tests, HBV DNA tests, liver function tests, mode of delivery, neonatal characteristics (height, weight, head circumference, Apgar score and any major birth defect), breastfeeding and post vaccination serological test for infants at 7-12 months of age are collected. A mobile health application called "SHIELD" is used in this study to collect data and provide support for communication between mothers and their doctors. All laboratory test reports, questionnaires and other relevant information are uploaded into SHIELD. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03272009 -
Evaluation of the Safety and Pharmacology of EYP001 in HBV Subjects
|
Phase 1 | |
| Recruiting |
NCT01456312 -
HBsAg Related Response Guided Therapy
|
Phase 4 | |
| Terminated |
NCT01886300 -
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive Chronic Hepatitis B in Vietnam
|
N/A | |
| Completed |
NCT01023230 -
A Study to Assess DV-601 in Subjects With Chronic Hepatitis B
|
Phase 1 | |
| Completed |
NCT00962975 -
A Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies
|
Phase 1 | |
| Completed |
NCT00536263 -
PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327)
|
Phase 3 | |
| Terminated |
NCT00460850 -
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B.
|
Phase 4 | |
| Completed |
NCT03681132 -
The Norwegian Nucleoside Analogue Stop Study
|
Phase 4 | |
| Active, not recruiting |
NCT05473806 -
Effects of Pioglitazone and Evogliptin on Hepatic Fibrosis in Patients With Chronic Hepatitis B With Type 2 Diabetes
|
Phase 4 | |
| Withdrawn |
NCT01179594 -
A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B.
|
Phase 4 | |
| Recruiting |
NCT05057065 -
A Clinical Research on Disease Progression and Intervention of Chronic HepatitisB
|
||
| Completed |
NCT04439539 -
A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection
|
Phase 2 | |
| Withdrawn |
NCT03125213 -
A Study Evaluating AL-3778 in Combination With Peginterferon Alpha-2a in Chronic Hepatitis B Subjects
|
Phase 2 | |
| Active, not recruiting |
NCT04782375 -
Safely Discontinue Antiviral Treatment in Patients With Chronic Hepatitis B
|
Phase 4 | |
| Withdrawn |
NCT05550519 -
A Study in Chronic Hepatitis B e-Antigen Negative Participants After Discontinuation of Nucleos(t)Ide Analog (NA) Treatment
|
Early Phase 1 | |
| Completed |
NCT02693652 -
A Study to Evaluate the Safety and Efficacy of Therapeutic Hepatitis B Vaccine
|
Phase 1/Phase 2 | |
| Enrolling by invitation |
NCT04160897 -
Risk of Hepatocellular Carcinoma in Patients Treated With ETV vs TDF for Chronic Hepatitis B With Compensated Cirrhosis
|
||
| Active, not recruiting |
NCT02588937 -
Active Drug Comparative Trial to Evaluate the Antiviral Activity and Safety in Chronic Hepatitis B Patients
|
Phase 4 | |
| Completed |
NCT02612506 -
Safety and Pharmacokinetic Study of Hepalatide(L47) in Healthy Volunteers
|
Phase 1 | |
| Recruiting |
NCT02327416 -
A Prospective Clinical Trial in Chronic Hepatitis B Patients NAs (Nucleotides or Nucleosides) Experienced (Anchor Study)
|
Phase 3 |