Clinical trial NCT02338674: TDF and LdT in Immune-tolerant CHB Patients Awaiting Assisted Reproduction
Official title: Combination Therapy of Tenofovir and Telbivudine in Immune-tolerant Patients With Chronic Hepatitis B Awaiting Assisted Reproduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hepatitis B, Chronic
Lead sponsor: Fuzhou General Hospital
Sponsor class: OTHER
First posted: 2015-01-14
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Immune-tolerant patients with chronic hepatitis B (CHB) awaiting assisted reproduction (AR) are required to initiate antiviral therapy due to laboratory safety. Additionally, rapid virus elimination is suggested to faciliate timely performance of AR. However, no consensus is reached regarding the antiviral therapy in this group. This study aimed to explore the efficacy and safety of tenofovir (TDF) and telbivudine (LdT) in this population.


Eligibility criteria: Inclusion Criteria:

* aged 18-45 years old with artificial reproductive needs
* Liver function (ALT) \<40U/L for male and \<30 for female
* HBV-DNA\> 10e+5
* HBVeAg +
* History\> 0.5 years

Exclusion Criteria:

* Cirrhosis
* 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

Primary outcomes:
measure: Percentage of Participants With HBV DNA < 500 Copies/mL at Week 12
timeFrame: week 12
Secondary outcomes:
measure: Percentage of Participants With HBV DNA < 500 Copies/mL at Week 24, 36 and 48
timeFrame: Week 24, 36 and 48
measure: Number of Participants With Normal Alanine Aminotransferase (ALT) at Week 12, 24, 36 and 48
timeFrame: Week 12, 24, 36 and 48
measure: Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 12, 24, 36 and 48
timeFrame: Week 12, 24, 36 and 48
measure: Number of Participants With Seroconversion to Antibody Against HBeAg (AntiHBe) at Week 12, 24, 36 and 48
timeFrame: Week 12, 24, 36 and 48
measure: Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12, 24, 36 and 48
timeFrame: Week 12, 24, 36 and 48
measure: Number of Participants With Seroconversion to Antibody to HBsAg (AntiHBs) at Week 12, 24, 36 and 48
timeFrame: Week 12, 24, 36 and 48
measure: Occurrence of HBV Resistance Mutations
timeFrame: Baseline to Week 48
measure: off-treatment recurrence of HBV
timeFrame: Week 72 to 96
measure: Down syndrome Occurrence
timeFrame: week 13 of pregnancy
measure: Fetal Malformations Occurrence
timeFrame: week 26 of pregnancy
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fuzhou General Hospital, Xiamen Univ
state: Fujian
Study officials:
affiliation: Department of Hepatobiliary Disease
name: Dongliangli Li, Dr.
role: STUDY_CHAIR
References: