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

900 Hospital of the People's Liberation Army Joint Logistic Support Force

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hepatitis B, Chronic

Treatments: Drug: Tenofovir; Drug: Tenofovir and telbivudine

Study type: Interventional

Funder types: Other

Identifiers

NCT02338674

HBV-AR

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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121 participants in 2 patient groups

COM

Experimental group

Description:

COM group receives combination therapy of tenofovir and telbivudine (TDF and LdT) for at least 48 weeks

Treatment:

Drug: Tenofovir and telbivudine

TDF

Active Comparator group

Description:

TDF group receives single therapy of tenofovir (TDF) for at least 48 weeks

Treatment:

Drug: Tenofovir