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

NCT ID: NCT03448744

Last Updated: 2018-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-25

Study Completion Date

2018-12-30

Brief Summary

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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

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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.

Conditions

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Chronic Hepatitis b

Keywords

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thymosin alpha entecavir

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Thymosin Alpha1

Intervention Type DRUG

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

Entecavir

Intervention Type DRUG

ETV (0.5 mg orally, daily) for 72 weeks

entecavir group

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

Group Type PLACEBO_COMPARATOR

Entecavir

Intervention Type DRUG

ETV (0.5 mg orally, daily) for 72 weeks

Interventions

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Thymosin Alpha1

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

Entecavir

ETV (0.5 mg orally, daily) for 72 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wen-hong Zhang

OTHER

Sponsor Role lead

Responsible Party

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Wen-hong Zhang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wenhong Zhang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of Infectious Diseases, Huashan Hospital

Locations

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Huashan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yiqi Yu, MD

Role: CONTACT

Phone: +86-21-52888123

Email: [email protected]

Ying Yue, MD

Role: CONTACT

Phone: +86-21-52888123

Email: [email protected]

Facility Contacts

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Wenhong Zhang, PhD,MD

Role: primary

Other Identifiers

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KY2016-219

Identifier Type: -

Identifier Source: org_study_id