Chronic Hepatitis B Clinical Trial
Verified date | April 2011 |
Source | Southeast University, China |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
Telbivudine reduces DNA and normalizes alanine aminotransferase levels (ALT) in chronic hepatitis B patients with few adverse effects, but its use during pregnancy has not been explored. In this open-label, prospective study from the second trimester to post-partum week 28. This trial is to study the efficacy, safety and tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women with high level of serum HBV DNA and elevated alanine aminotransferase levels.
Status | Completed |
Enrollment | 88 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility |
Inclusion Criteria: - age between 20-40 years - gestational age between 12-30 weeks - serum HBsAg and HBeAg positivity - HBV DNA levels >6log10 copies/mL - ALT >1x ULN (40 IU/mL) and < 10x ULN. Exclusion Criteria: - co-infection with hepatitis A, C, D, E or HIV - evidence of hepatocellular carcinoma; decompensated liver disease or significant renal, cardiovascular, respiratory or neurological co-morbidity - concurrent treatment with immune-modulators, cytotoxic drugs, or steroids - clinical signs of threatened miscarriage in early pregnancy - evidence of fetal deformity by 3-dimensional ultrasound examination - the biological father of the child had CHB |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Department of Gynecology and Obstetrics, The Second Affiliated Hospital of the Southeast University | Nan Jing | Jiang Su |
Lead Sponsor | Collaborator |
---|---|
Southeast University, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The efficacy of Telbivudine treatment (DNA reduction, ALT normalization, and infants' immunoprophylaxis failure) and safety | From late pregnancy to 28 weeks of postpartum | Yes | |
Secondary | Changes in maternal HBeAg titers and lost/seroconversion of HBeAg or HBsAg | From late pregnancy to 28 weeks of postpartum | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04496882 -
Chronic Hepatitis b Patients Switch to tAf After Discontinuation of Nucleoside Analogue
|
Phase 4 | |
Completed |
NCT04083716 -
A Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adults
|
Phase 1 | |
Not yet recruiting |
NCT03038802 -
A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection
|
Phase 1/Phase 2 | |
Completed |
NCT05310487 -
Phase 1 Study of 162, a Novel Neutralizing Antibody Targeting Hepatitis B Surface Antigen, in Healthy Adult Subjects
|
Phase 1 | |
Recruiting |
NCT06070051 -
Dose-Escalation Prime/Boost Therapeutic Vaccination Study Of 2 Chimp Adenoviral Vectors in Adults With Chronic HBV On Nucleos(t)Ide Therapy
|
Phase 1 | |
Terminated |
NCT05001022 -
A Study of ALG-020572 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Doses in Healthy Volunteers and Multiple Doses in CHB Subjects
|
Phase 1 | |
Recruiting |
NCT04139850 -
The Establishment of Korean Hepatitis B Patients Cohort
|
||
Recruiting |
NCT05343481 -
Efficacy of VTP-300 in Chronic Hepatitis B Infection
|
Phase 2 | |
Not yet recruiting |
NCT05490836 -
Functional Cure Rate of Peg-IFNα-2b Combined With TAF in HBeAg Negative CHB Patients
|
N/A | |
Recruiting |
NCT04543565 -
Pradefovir Treatment for the Patients With Chronic Hepatitis B Virus Infections: a Phase3 Study
|
Phase 3 | |
Active, not recruiting |
NCT02894918 -
A Study to Evaluate Addition of Peginterferon Alfa-2a to Chronic Hepatitis B (CHB) Patients Treated With NAs
|
Phase 4 | |
Not yet recruiting |
NCT02793791 -
Prophylactic Treatment of Hepatic Dysplastic Nodules in HBsAg Positive Patients
|
N/A | |
Recruiting |
NCT02287857 -
Efficacy and Safety of Domestic Tenofovir Tablets in Chinese Patients With Chronic Hepatitis B
|
N/A | |
Recruiting |
NCT01965418 -
A Clinical Evaluation on Traditional Chinese Medicine Diagnosis and Treatment Program Blocking and Reversing Hepatitis B-related Liver Fibrosis - a Randomized, Controlled, Double-blind, Multi-center Clinical Trial
|
Phase 4 | |
Recruiting |
NCT01491295 -
Switch to Tenofovir Versus Continue Lamivudine/Adefovir Treatment in Lamivudine-resistance Chronic Hepatitis B Patients
|
Phase 4 | |
Terminated |
NCT01872988 -
Tenofovir Antiviral Therapy Following Transarterial Chemoembolization for HBV Related Hepatocellular Carcinoma
|
Phase 3 | |
Recruiting |
NCT01487876 -
Efficacy and Safety of Dual-plasmid Hepatitis B Virus DNA Vaccine in Chronic Hepatitis B Patients
|
Phase 2 | |
Not yet recruiting |
NCT01436539 -
Study of Effects and Safety Between Adefovir Dipivoxil Plus Polyene Phosphatidylcholine Versus Adefovir Dipivoxil Alone in Chronic Hepatitis B Patients
|
Phase 4 | |
Completed |
NCT01531166 -
A Cohort Study in Korean Patients With Chronic Hepatitis B (CHB) Receiving Pegylated Interferon
|
N/A | |
Recruiting |
NCT01360879 -
Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease
|
N/A |