Overview

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

Status:
Completed
Trial end date:
2017-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fuzhou General Hospital
Treatments:
Telbivudine
Tenofovir
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