Efficacy and Safety of Combination Therapy of Thymalfasin... | NCT03448744

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

NCT03448744

Sponsor

Wen-hong Zhang

Status

Unknown status

Last Update Posted

Feb 28, 2018Actual

Enrollment

240Estimated

Phase

Phase 4

Conditions

Chronic Hepatitis b

Interventions

Thymosin Alpha1
Entecavir

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 25, 2017Actual

Primary Completion Date

Dec 30, 2018Estimated

Completion Date

Dec 30, 2018Estimated

First Submitted Date

Feb 22, 2018

First Submission Date that Met QC Criteria

Feb 22, 2018

First Posted Date

Feb 28, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2018

Last Update Posted Date

Feb 28, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 Alpha1 Drug: Entecavir
entecavir group	Placebo Comparator	ETV (0.5 mg orally, daily) at least for 72 weeks	Drug: Entecavir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thymosin Alpha1	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HBeAg seroconversion rate at week 72	HBeAg seroconversion rate at week 72	week 72

Secondary Outcomes

Measure	Description	Time Frame
HBeAg seroconversion rate at week 48	HBeAg seroconversion rate at week 48	week 48
HBsAg loss at week 48	HBsAg loss at week 48	week 48

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yiqi Yu, MD	Contact	+86-21-52888123		yyq19890619@126.com
Ying Yue, MD	Contact	+86-21-52888123		ye_zicissy@sohu.com

Overall Officials

Name	Affiliation	Role
Wenhong Zhang, Ph.D	Department of Infectious Diseases, Huashan Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Huashan Hospital of Fudan University	Recruiting	Shanghai	Shanghai Municipality	200040	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D019694	Hepatitis B, Chronic

ID	Term
D006509	Hepatitis B
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Intervention Browse Module

MeSH Terms

ID	Term
D000077596	Thymalfasin
C413685	entecavir

Ancestor Terms

ID	Term
D013947	Thymosin
D013951	Thymus Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

Browse Leaves

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Browse Branches

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