TDF and LdT in Immune-tolerant CHB Patients Awaiting Assisted Reproduction
NCT ID: NCT02338674
Last Updated: 2018-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
121 participants
INTERVENTIONAL
2014-10-31
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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COM
COM group receives combination therapy of tenofovir and telbivudine (TDF and LdT) for at least 48 weeks
Tenofovir and telbivudine
tenofovir and telbivudine administered at least 48 weeks
TDF
TDF group receives single therapy of tenofovir (TDF) for at least 48 weeks
Tenofovir
tenofovir administered at least 48 weeks
Interventions
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Tenofovir and telbivudine
tenofovir and telbivudine administered at least 48 weeks
Tenofovir
tenofovir administered at least 48 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Liver function (ALT) \<40U/L for male and \<30 for female
* HBV-DNA\> 10e+5
* HBVeAg +
* History\> 0.5 years
Exclusion Criteria
* Combined with other liver diseases such as autoimmune liver disease, alcoholic liver disease, fatty liver
* Liver or other parts of malignancies
* Bilirubin\> 17.1
* GGT\> 2ULN
* Liver transplant patients
* combined HCV, HDV, HIV infection
* A history of anti-HBV drug resistance
* History of habitual abortion
* previous fetal malformation history
* CRP\> 3.0ng / ml
* Uncontrolled hypertension
* Proteinuria or Calculated creatinine clearance \< 70 mL/min
* Heart failure or acute coronary syndrome
* Coagulopathy
* Drug or alcohol addiction
* Hyperlipidemia LDL\> 4.6 or TG\> 2.0
* Alphafetoprotein \> 50 ng/mL
* Received interferon (pegylated or not) therapy within 6 months of the screening visit
* Evidence of hepatocellular carcinoma
* Received solid organ or bone marrow transplantation
* Was currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents
* Known hypersensitivity to the study drugs, the metabolites, or formulation excipients
18 Years
45 Years
ALL
No
Sponsors
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Fuzhou General Hospital
OTHER
Responsible Party
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Dongliang Li
Director, Department of Hepatobiliary Disease
Principal Investigators
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Dongliangli Li, Dr.
Role: STUDY_CHAIR
Department of Hepatobiliary Disease
Locations
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Fuzhou General Hospital, Xiamen Univ
Fuzhou, Fujian, China
Countries
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Other Identifiers
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HBV-AR
Identifier Type: -
Identifier Source: org_study_id
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