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Completed

NCT Number: NCT02338674

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

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.

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Key information

Conditions

Hepatitis B, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Fuzhou General Hospital, Xiamen Univ

Fuzhou, Fujian, 350025, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tenofovir and telbivudine

Drug

tenofovir and telbivudine administered at least 48 weeks

Other names: combination therapy

Tenofovir

Drug

tenofovir administered at least 48 weeks

Other names: single therapy

Primary outcomes

  1. Percentage of Participants With HBV DNA < 500 Copies/mL at Week 12

    Time frame: week 12

Secondary outcomes

  1. Percentage of Participants With HBV DNA < 500 Copies/mL at Week 24, 36 and 48

    Time frame: Week 24, 36 and 48

  2. Number of Participants With Normal Alanine Aminotransferase (ALT) at Week 12, 24, 36 and 48

    Time frame: Week 12, 24, 36 and 48

  3. Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 12, 24, 36 and 48

    Time frame: Week 12, 24, 36 and 48

  4. Number of Participants With Seroconversion to Antibody Against HBeAg (AntiHBe) at Week 12, 24, 36 and 48

    Time frame: Week 12, 24, 36 and 48

  5. Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12, 24, 36 and 48

    Time frame: Week 12, 24, 36 and 48

  6. Number of Participants With Seroconversion to Antibody to HBsAg (AntiHBs) at Week 12, 24, 36 and 48

    Time frame: Week 12, 24, 36 and 48

  7. Occurrence of HBV Resistance Mutations

    Time frame: Baseline to Week 48

  8. off-treatment recurrence of HBV

    Time frame: Week 72 to 96

  9. Down syndrome Occurrence

    Time frame: week 13 of pregnancy

  10. Fetal Malformations Occurrence

    Time frame: week 26 of pregnancy

Sponsors and collaborators

Lead sponsor

Fuzhou General Hospital

Other

Registry information

Official study title

Combination Therapy of Tenofovir and Telbivudine in Immune-tolerant Patients With Chronic Hepatitis B Awaiting Assisted Reproduction

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jan 14, 2015
Registry last updated
Sep 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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