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

Hepatitis B, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02338674
• Other study ID #: HBV-AR
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 2014
• Est. completion date: October 2017

Study information

• Verified date: September 2018
• Source: Fuzhou General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: October 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• Tenofovir and telbivudine
tenofovir and telbivudine administered at least 48 weeks
• Tenofovir
tenofovir administered at least 48 weeks

Locations

Country	Name	City	State
China	Fuzhou General Hospital, Xiamen Univ	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fuzhou General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With HBV DNA < 500 Copies/mL at Week 12		week 12
Secondary	Percentage of Participants With HBV DNA < 500 Copies/mL at Week 24, 36 and 48		Week 24, 36 and 48
Secondary	Number of Participants With Normal Alanine Aminotransferase (ALT) at Week 12, 24, 36 and 48		Week 12, 24, 36 and 48
Secondary	Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 12, 24, 36 and 48		Week 12, 24, 36 and 48
Secondary	Number of Participants With Seroconversion to Antibody Against HBeAg (AntiHBe) at Week 12, 24, 36 and 48		Week 12, 24, 36 and 48
Secondary	Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12, 24, 36 and 48		Week 12, 24, 36 and 48
Secondary	Number of Participants With Seroconversion to Antibody to HBsAg (AntiHBs) at Week 12, 24, 36 and 48		Week 12, 24, 36 and 48
Secondary	Occurrence of HBV Resistance Mutations		Baseline to Week 48
Secondary	off-treatment recurrence of HBV		Week 72 to 96
Secondary	Down syndrome Occurrence		week 13 of pregnancy
Secondary	Fetal Malformations Occurrence		week 26 of pregnancy