NCT03448744

Brief Summary

This is a multicenter, randomized, open-label control trial of two arms conducted at 10 centres in China.The aim was to investigate whether sequential combination therapy with Thymosin alpha 1 and entecavir is superior to continuous ETV monotherapy in HBeAg-positive chronic hepatitis B patients with previous long-term entecavir therapy (≥ 2 years), and to select the optimal patients who may benefit from sequential combination therapy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

1.2 years

First QC Date

February 22, 2018

Last Update Submit

February 22, 2018

Conditions

Chronic Hepatitis b

Keywords

thymosin alphaentecavir

Outcome Measures

Primary Outcomes (1)

  • HBeAg seroconversion rate at week 72

    HBeAg seroconversion rate at week 72

    week 72

Secondary Outcomes (10)

  • HBeAg seroconversion rate at week 48

    week 48

  • HBsAg loss at week 48

    week 48

  • HBsAg loss at week 72

    week 72

  • HBsAg seroconversion at week 72

    week 72

  • HBsAg seroconversion at week 48

    week 48

  • +5 more secondary outcomes

Study Arms (2)

combiantion therapy group

EXPERIMENTAL

thymosin alpha 1 (1.6 mg subcutaneously injection twice a week) plus ETV (0.5 mg orally, daily) for 24 weeks, and followed by continuous ETV for at least 48 weeks

Drug: Thymosin Alpha1Drug: Entecavir

entecavir group

PLACEBO COMPARATOR

ETV (0.5 mg orally, daily) at least for 72 weeks

Drug: Entecavir

Interventions

Thymosin Alpha1DRUG

Thymosin Alpha1 (1.6 mg subcutaneously injection twice a week) plus ETV (0.5 mg orally, daily) for 24 weeks, and followed by continuous ETV for at least 48 weeks

combiantion therapy group
EntecavirDRUG

ETV (0.5 mg orally, daily) for 72 weeks

combiantion therapy groupentecavir group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • HBsAg positive and anti-HBs negative for more than 6 months
  • Being currently treated with ETV ≥1 years
  • HBeAg positivity and HBV DNA \<60IU/mL with HBsAg \<1500IU/mL and HBeAg \<200S/CO at screening
  • ALT ≤5\*ULN and total bilirubin ≤2\*ULN
  • Age ≥ 18 yrs but ≤ 55 yrs
  • Written informed consent

You may not qualify if:

  • Patients who have contraindications for Thymosin alpha 1 in accordance with the approved summary of product characteristics
  • Patients with ALT \> 5 x ULN or total bilirubin \>2\*ULN
  • Patients with evidence of hepatocellular carcinoma at screening
  • Patients with Child-Pugh score ≥7 or had a history of hepatic encephalopathy or esophageal pile or ascites
  • Patients with serological evidence of co-infection with hepatitis A virus, hepatitis C, human immunodeficiency virus or hepatitis D virus
  • Patients with a history of excessive drinking: male \>40g/d,female \>40g/d
  • Pregnant or breast-feeding women
  • A history of liver transplantation or planned for liver transplantation
  • Patients of autoimmune disease
  • Patients with other diseases combined
  • Patients with creatinine \>1.5\*ULN
  • Investigator considered not proper for participating the trial
  • Patients with other maliginant tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Thymalfasinentecavir

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)

ThymosinThymus HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptide HormonesPeptidesAmino Acids, Peptides, and ProteinsProteins

Study Officials

  • Wenhong Zhang, Ph.D

    Department of Infectious Diseases, Huashan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yiqi Yu, MD

CONTACT

+86-21-52888123yyq19890619@126.com

Ying Yue, MD

CONTACT

+86-21-52888123ye_zicissy@sohu.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 22, 2018

First Posted

February 28, 2018

Study Start

October 25, 2017

Primary Completion

December 30, 2018

Study Completion

December 30, 2018

Last Updated

February 28, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)