NCT02338674

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 14, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

September 24, 2018

Status Verified

September 1, 2018

Enrollment Period

2 years

First QC Date

January 11, 2015

Last Update Submit

September 21, 2018

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

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

    week 12

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

COM

EXPERIMENTAL

COM group receives combination therapy of tenofovir and telbivudine (TDF and LdT) for at least 48 weeks

Drug: Tenofovir and telbivudine

TDF

ACTIVE COMPARATOR

TDF group receives single therapy of tenofovir (TDF) for at least 48 weeks

Drug: Tenofovir

Interventions

Tenofovir and telbivudineDRUG

tenofovir and telbivudine administered at least 48 weeks

Also known as: combination therapy
COM
TenofovirDRUG

tenofovir administered at least 48 weeks

Also known as: single therapy
TDF

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuzhou General Hospital, Xiamen Univ

Fuzhou, Fujian, 350025, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

TenofovirTelbivudineCombined Modality TherapyTherapeutics

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Dongliangli Li, Dr.

    Department of Hepatobiliary Disease

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Department of Hepatobiliary Disease

Study Record Dates

First Submitted

January 11, 2015

First Posted

January 14, 2015

Study Start

October 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2017

Last Updated

September 24, 2018

Record last verified: 2018-09

Locations

CN(1)