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Trial · Interventional

Status unknownPhase 4Registry data

Efficacy and Safety of Combination Therapy of Thymalfasin and Entecavir in HBeAg-positive ETV-experienced Patients

NCTNCT03448744 (opens ClinicalTrials.gov in a new tab)Other idKY2016-219
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
240 participants (estimated)
Sponsor
Wen-hong Zhang · Other
Design
Randomized · Single masking
Countries
1 country

China

Start
25 Oct 2017
Primary completion
30 Dec 2018 (estimated)
Completion
30 Dec 2018 (estimated)
First posted
28 Feb 2018
Last update posted
28 Feb 2018
Conditions
Chronic Hepatitis b

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201720182019
  1. Ph 4

    Efficacy and Safety of Combination Therapy of Thymalfasin and Entecavir in HBeAg-positive ETV-experienced Patients

    NCT03448744

    25 Oct 2017 to est. 30 Dec 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Thymosin Alpha1Drug
  • EntecavirDrug

Arms2

  • Experimental

    combiantion therapy group

    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

  • Placebo comparator

    entecavir group

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. HBeAg seroconversion rate at week 72

    Time frame · week 72

    Registry description

    HBeAg seroconversion rate at week 72

Secondary outcomes(10)

  1. HBeAg seroconversion rate at week 48

    Time frame · week 48

    Registry description

    HBeAg seroconversion rate at week 48

  2. HBsAg loss at week 48

    Time frame · week 48

    Registry description

    HBsAg loss at week 48

  3. HBsAg loss at week 72

    Time frame · week 72

    Registry description

    HBsAg loss at week 72

  4. HBsAg seroconversion at week 72

    Time frame · week 72

    Registry description

    HBsAg seroconversion at week 72

  5. HBsAg seroconversion at week 48

    Time frame · week 48

    Registry description

    HBsAg seroconversion at week 48

  6. HBsAg decline during the clinical trial

    Time frame · week 12, weeek 24, week 36, week 48 and week 72

    Registry description

    HBsAg decline during the clinical trial

  7. ALT normalization rate at week 72

    Time frame · week 72

    Registry description

    ALT normalization rate at week 72

  8. ALT normalization rate at week 48

    Time frame · week 48

    Registry description

    ALT normalization rate at week 48

  9. Rate of HBV DNA <20IU/mL at week 72

    Time frame · week 72

    Registry description

    Rate of HBV DNA \<20IU/mL at week 72

  10. Rate of HBV DNA <20IU/mL at week 48

    Time frame · week 48

    Registry description

    Rate of HBV DNA \<20IU/mL at week 48

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 55 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 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

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