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A randomized, prospective, comparative study of the effectiveness of prophylactic entecavir treatment for HBV reactivation in past HBV infected patients with hematopoietic stem cell transplantation

Status Approved

First Submitted Date

2020/10/04
Registered Date

2020/10/15
Last Updated Date

2021/06/22

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005483
Unique Protocol ID	KC20MISI0622
Public/Brief Title	A randomized, prospective, comparative study of the effectiveness of prophylactic entecavir treatment for HBV reactivation in past HBV infected patients with hematopoietic stem cell transplantation
Scientific Title	A randomized, prospective, comparative study of the effectiveness of prophylactic entecavir treatment for HBV reactivation in past HBV infected patients with hematopoietic stem cell transplantation
Acronym
MFDS Regulated Study	No
IND/IDE Protocol
Registered at Other Registry	No
Healthcare Benefit Approval Status	Submitted approval

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	KC20MISI0622
Approval Date	2020-09-10
Institutional Review Board Name	Institutional review board of Seoul St. Mary's Hospital
Institutional Review Board Address	222, Banpo-daero, Seocho-gu, Seoul
Institutional Review Board Telephone	02-2258-8202
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Jeong Won Jang
Title	M.D. Ph.D.
Telephone	+82-2-2258-2073
Affiliation	The Catholic University of Korea
Address	22 BANPO-DAERO, SEOCHO-GU, SEOUL
Contact Person for Public Queries
Name	Soon Kyu Lee
Title	Dr.
Telephone	+82-2-2258-2073
Affiliation	The Catholic University of Korea, Seoul St. Mary's Hospital
Address	22 BANPO-DAERO, SEOCHO-GU, SEOUL
Contact Person for Updating Information
Name	Jeong Won Jang
Title	M.D. Ph.D.
Telephone	+82-2-2258-2073
Affiliation	The Catholic University of Korea
Address	22 BANPO-DAERO, SEOCHO-GU, SEOUL

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-07-22 Anticipated
Target Number of Participant	164
Primary Completion Date
Study Completion Date
Name of Study	The Catholic University of Korea, Seoul St. Mary's Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-07-22 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Dong-A Pharm
Organization Type	Pharmaceutical Company
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	The Catholic University of Korea, Seoul St. Mary's Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	This study is a randomized, prospective, comparative study of the effectiveness of prophylactic entecavir treatment for HBV reactivation in past HBV infected patients (HBsAg-, HBcIgG+) with hematopoietic stem cell transplantation.

Study Summary Information

Lay Summary

This study is a randomized, prospective, comparative study of the effectiveness of prophylactic entecavir treatment for HBV reactivation in past HBV infected patients (HBsAg-, HBcIgG+) with hematopoietic stem cell transplantation.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Not applicable
Intervention Model	Single Group
Blinding/Masking	Open
Allocation	RCT
Intervention Type	Drug
Intervention Description	The intervention group take entecavir 0.5mg everyday by oral administration for 3 years.
Number of Arms	1
Arm 1	Arm Label prophylactic entecavir treatment group
	Target Number of Participant 82
	Arm Type Experimental
	Arm Description The intervention group take entecavir 0.5mg everyday by oral administration for 3 years.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	(D50-D89)Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism past HBV infected patients with hematopoietic stem cell transplantation
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~70Year
	Description 1. Age: 19 - 70 2. patients receiving hematopoietic stem cell transplantation 3. HBV serologic test: HBsAg (-), anti-HBc IgG (+) 4. ECOG performence: 0-2 5. patients with informed consent
Exclusion Criteria	1. HBV DNA (+, ≥10 IU/mL) at the time of screening 2. Receiving hematopoietic stem cell transplantation from donor with HBsAg+ 3. Combined other chronic liver disease (severe alcoholics, autoimmune hepatitis, chronic hepatitis C etc.) 4. HIV (+) 5. Previous antiviral therapy history for chronic hepatitis B 6. Other concomitant malignancy 7. combined autoimmune disease (rheumatic arthritis, SLE etc) 8. CTP class B, C 9. Decompensated complications (ascites, hepatic encephalopathy etc.) 10. active tuberculosis
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	comparison of HBV reactivation rate (HBsAg reverse seroconversion or detection of HBV DNA (≥10 IU/mL))
Timepoint	from the time of hematopoietic stem cell transplantation to the 3 years after hematopoietic stem cell transplantation
Secondary Outcome(s) 1
Outcome	the rate of hepatitis due to HBV reactivation (Hepatitis: ALT levels more than twice of normal range)
Timepoint	from the time of hematopoietic stem cell transplantation to the 3 years after hematopoietic stem cell transplantation
Secondary Outcome(s) 2
Outcome	the rate of hepatic failure related to HBV reactivation
Timepoint	from the time of hematopoietic stem cell transplantation to the 3 years after hematopoietic stem cell transplantation
Secondary Outcome(s) 3
Outcome	the rate of death due to hepatic failure related to HBV reactivation
Timepoint	from the time of hematopoietic stem cell transplantation to the 3 years after hematopoietic stem cell transplantation

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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