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

Primary Purpose

Chronic Hepatitis b

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Thymosin Alpha1
Entecavir
Sponsored by
Wen-hong Zhang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis b focused on measuring thymosin alpha, entecavir

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Huashan Hospital of Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

combiantion therapy group

entecavir group

Arm Description

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

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

Outcomes

Primary Outcome Measures

HBeAg seroconversion rate at week 72
HBeAg seroconversion rate at week 72

Secondary Outcome Measures

HBeAg seroconversion rate at week 48
HBeAg seroconversion rate at week 48
HBsAg loss at week 48
HBsAg loss at week 48
HBsAg loss at week 72
HBsAg loss at week 72
HBsAg seroconversion at week 72
HBsAg seroconversion at week 72
HBsAg seroconversion at week 48
HBsAg seroconversion at week 48
HBsAg decline during the clinical trial
HBsAg decline during the clinical trial
ALT normalization rate at week 72
ALT normalization rate at week 72
ALT normalization rate at week 48
ALT normalization rate at week 48
Rate of HBV DNA <20IU/mL at week 72
Rate of HBV DNA <20IU/mL at week 72
Rate of HBV DNA <20IU/mL at week 48
Rate of HBV DNA <20IU/mL at week 48

Full Information

First Posted
February 22, 2018
Last Updated
February 22, 2018
Sponsor
Wen-hong Zhang
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1. Study Identification

Unique Protocol Identification Number
NCT03448744
Brief Title
Efficacy and Safety of Combination Therapy of Thymalfasin and Entecavir in HBeAg-positive ETV-experienced Patients
Official Title
A Multicenter, Randomized, Open-label Control Study to Evaluate Efficacy and Safety of Combination Therapy of Thymalfasin and Entecavir in HBeAg-positive ETV-experienced Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 25, 2017 (Actual)
Primary Completion Date
December 30, 2018 (Anticipated)
Study Completion Date
December 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wen-hong Zhang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
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 (≥ 1 years), and to select the optimal patients who may benefit from sequential combination therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis b
Keywords
thymosin alpha, entecavir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
combiantion therapy group
Arm Type
Experimental
Arm Description
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
Arm Title
entecavir group
Arm Type
Placebo Comparator
Arm Description
ETV (0.5 mg orally, daily) at least for 72 weeks
Intervention Type
Drug
Intervention Name(s)
Thymosin Alpha1
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Entecavir
Intervention Description
ETV (0.5 mg orally, daily) for 72 weeks
Primary Outcome Measure Information:
Title
HBeAg seroconversion rate at week 72
Description
HBeAg seroconversion rate at week 72
Time Frame
week 72
Secondary Outcome Measure Information:
Title
HBeAg seroconversion rate at week 48
Description
HBeAg seroconversion rate at week 48
Time Frame
week 48
Title
HBsAg loss at week 48
Description
HBsAg loss at week 48
Time Frame
week 48
Title
HBsAg loss at week 72
Description
HBsAg loss at week 72
Time Frame
week 72
Title
HBsAg seroconversion at week 72
Description
HBsAg seroconversion at week 72
Time Frame
week 72
Title
HBsAg seroconversion at week 48
Description
HBsAg seroconversion at week 48
Time Frame
week 48
Title
HBsAg decline during the clinical trial
Description
HBsAg decline during the clinical trial
Time Frame
week 12, weeek 24, week 36, week 48 and week 72
Title
ALT normalization rate at week 72
Description
ALT normalization rate at week 72
Time Frame
week 72
Title
ALT normalization rate at week 48
Description
ALT normalization rate at week 48
Time Frame
week 48
Title
Rate of HBV DNA <20IU/mL at week 72
Description
Rate of HBV DNA <20IU/mL at week 72
Time Frame
week 72
Title
Rate of HBV DNA <20IU/mL at week 48
Description
Rate of HBV DNA <20IU/mL at week 48
Time Frame
week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yiqi Yu, MD
Phone
+86-21-52888123
Email
yyq19890619@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Yue, MD
Phone
+86-21-52888123
Email
ye_zicissy@sohu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenhong Zhang, Ph.D
Organizational Affiliation
Department of Infectious Diseases, Huashan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huashan Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenhong Zhang, PhD,MD
Phone
+86 21 52889999
Ext
8123
Email
zhangwenhong@fudan.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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

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