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

NCT02338674 — Phase 1 / Phase 2, Completed, 121 participants, Fuzhou General Hospital

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

Registry	NCT02338674
Status	Completed
Phase	Phase 1 / Phase 2
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	121 (Actual)
Sponsor	Fuzhou General Hospital (Other)
Conditions	Hepatitis B, Chronic
Interventions	Tenofovir and telbivudine, Tenofovir (Drug)
Dates	start 2014-10-01, primary completion 2016-10-01, completion 2017-10-01, first posted 2015-01-14, last updated 2018-09-24
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
COM	Experimental	Drug: Tenofovir and telbivudine	COM group receives combination therapy of tenofovir and telbivudine (TDF and LdT) for at least 48 weeks
TDF	Active comparator	Drug: Tenofovir	TDF group receives single therapy of tenofovir (TDF) for at least 48 weeks

Tenofovir and telbivudine (Drug), also known as combination therapy: tenofovir and telbivudine administered at least 48 weeks
Tenofovir (Drug), also known as single therapy: tenofovir administered at least 48 weeks

+Outcome measures

Primary outcomes

Percentage of Participants With HBV DNA < 500 Copies/mL at Week 12 [week 12]

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 45 Years

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

+Locations (1)

Facility	City	Country	Status
Fuzhou General Hospital, Xiamen Univ	Fuzhou, Fujian	China

+Investigators

Dongliangli Li, Dr., Study chair, Department of Hepatobiliary Disease