TDF and LdT in Immune-tolerant CHB Patients Awaiting Assisted Reproduction

Phase 1

Completed

• Conditions: Hepatitis B, Chronic
• Interventions: Drug: Tenofovir and telbivudine; Drug: Tenofovir

• Registration Number: NCT02338674
• Lead Sponsor: Fuzhou General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-01-11
• Study First Submitted QC: 2015-01-13
• Study First Posted: 2015-01-14
• Primary Completion: 2016-10
• Study Completion: 2017-10
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-21
• Last Update Posted: 2018-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COM	Tenofovir and telbivudine	COM group receives combination therapy of tenofovir and telbivudine (TDF and LdT) for at least 48 weeks
TDF	Tenofovir	TDF group receives single therapy of tenofovir (TDF) for at least 48 weeks

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With HBV DNA < 500 Copies/mL at Week 12	week 12

Secondary Outcome Measures

Name	Time	Method
Occurrence of HBV Resistance Mutations	Baseline to Week 48
Fetal Malformations Occurrence	week 26 of pregnancy
Number of Participants With Normal Alanine Aminotransferase (ALT) at Week 12, 24, 36 and 48	Week 12, 24, 36 and 48
Percentage of Participants With HBV DNA < 500 Copies/mL at Week 24, 36 and 48	Week 24, 36 and 48
Number of Participants With Seroconversion to Antibody to HBsAg (AntiHBs) at Week 12, 24, 36 and 48	Week 12, 24, 36 and 48
Number of Participants With Seroconversion to Antibody Against HBeAg (AntiHBe) at Week 12, 24, 36 and 48	Week 12, 24, 36 and 48
Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12, 24, 36 and 48	Week 12, 24, 36 and 48
Down syndrome Occurrence	week 13 of pregnancy
Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 12, 24, 36 and 48	Week 12, 24, 36 and 48
off-treatment recurrence of HBV	Week 72 to 96

Trial Locations

Locations (1)

Fuzhou General Hospital, Xiamen Univ; 🇨🇳 Fuzhou, Fujian, China