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

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ClinicalTrials.gov Identifier: NCT02338674
Recruitment Status : Completed
First Posted : January 14, 2015
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Dongliang Li, 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.

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: Tenofovir and telbivudine Drug: Tenofovir Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination Therapy of Tenofovir and Telbivudine in Immune-tolerant Patients With Chronic Hepatitis B Awaiting Assisted Reproduction
Actual Study Start Date : October 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2017

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Arm Intervention/treatment
Experimental: COM
COM group receives combination therapy of tenofovir and telbivudine (TDF and LdT) for at least 48 weeks
Drug: Tenofovir and telbivudine
tenofovir and telbivudine administered at least 48 weeks
Other Name: combination therapy

Active Comparator: TDF
TDF group receives single therapy of tenofovir (TDF) for at least 48 weeks
Drug: Tenofovir
tenofovir administered at least 48 weeks
Other Name: single therapy




Primary Outcome Measures :
  1. Percentage of Participants With HBV DNA < 500 Copies/mL at Week 12 [ Time Frame: week 12 ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02338674


Locations
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China, Fujian
Fuzhou General Hospital, Xiamen Univ
Fuzhou, Fujian, China, 350025
Sponsors and Collaborators
Fuzhou General Hospital
Investigators
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Study Chair: Dongliangli Li, Dr. Department of Hepatobiliary Disease

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Responsible Party: Dongliang Li, Director, Department of Hepatobiliary Disease, Fuzhou General Hospital
ClinicalTrials.gov Identifier: NCT02338674     History of Changes
Other Study ID Numbers: HBV-AR
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis B, Chronic
Tenofovir
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Telbivudine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents