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出境医 / 临床实验 / Prophylactic Entecavir for HBV Reactivation in Past HBV Infected Patients With Hematopoietic Stem Cell Transplantation

Prophylactic Entecavir for HBV Reactivation in Past HBV Infected Patients With Hematopoietic Stem Cell Transplantation

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Hepatitis B Reactivation Hematopoietic Stem Cell Transplantation Antiviral Drug HBV Drug: Entecavir Not Applicable

Detailed Description:

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.

In this study, patients are randomized into treatment group or delayed treatment group.

* Stratified randomization (Block randomization within strata) according to the presence of HBsAb at baseline was used in this study.

  1. Experimental: Treatment group (n=82) The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after hematopoietic stem cell transplantation. The intervention group visit clinic every month and examined liver function test, HBsAg/Ab. HBV DNA level is examined at every 3 months.

    * oral administration of entecavir is planned to start within 7 days after hematopoietic stem cell transplantation.

  2. No Intervention: delayed treatment group (n=82) The delayed treatment group visit clinic every month and examined liver function test, HBsAg/Ab. HBV DNA level is examined at every 3 months. If the patient in the delayed treatment group shows HBV reactivation (positive HBsAg or HBV DNA ≥10 IU/mL), entecavir treatment is started.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : July 25, 2021
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025
Arms and Interventions
Arm Intervention/treatment
Experimental: Treatment group
The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after hematopoietic stem cell transplantation. The intervention group visit clinic every month and examined liver function test, HBsAg/Ab. HBV DNA level is examined at every 3 months.
 Drug: Entecavir
The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after hematopoietic stem cell transplantation.
Other Name: Prophylactic treatment group
No Intervention: delayed treatment group
The delayed treatment group visit clinic every month and examined liver function test, HBsAg/Ab. HBV DNA level is examined at every 3 months. If the patient in the delayed treatment group shows HBV reactivation (positive HBsAg or HBV DNA ≥10 IU/mL), entecavir treatment is started.
Outcome Measures
Primary Outcome Measures :
  1. Comparison of the rate of HBV reactivation between the treatment and delayed treatment groups. [ Time Frame: The primary outcome is evaluated during 3 years after hematopoietic stem cell transplantation ]

    Comparing the rate of HBV reactivation between the treatment and delayed treatment groups during 3 years after hematopoietic stem cell transplantation

    * Definition of HBV reactivation: HBsAg ≥ 1.0 S/CO or HBV DNA ≥ 10 IU/mL



Secondary Outcome Measures :
  1. Comparison of the rate of active hepatitis with HBV reactivation between the treatment and delayed treatment groups. [ Time Frame: The secondary outcomes are evaluated during 3 years after hematopoietic stem cell transplantation. ]

    Comparing the rate of active hepatitis with HBV reactivation between the treatment and delayed treatment groups.

    * Definition of active hepatitis: ALT >= 2 times of upper normal limit


  2. Comparison of the rate of hepatic failure related to HBV reactivation between the treatment and delayed treatment groups. [ Time Frame: The secondary outcomes are evaluated during 3 years after hematopoietic stem cell transplantation. ]
    Comparing the rate of hepatic failure between the treatment and delayed treatment groups.

  3. Comparison of the rate of survival related to HBV reactivation between the treatment and delayed treatment groups. [ Time Frame: The secondary outcomes are evaluated during 3 years after hematopoietic stem cell transplantation. ]
    Comparing the rate of survival related to HBV reactivation between the treatment and delayed treatment groups.


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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
Contacts and Locations

Contacts
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Contact: Jeong Won Jang, Professor 82-10-5204-9400 garden@catholic.ac.kr

Locations
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Korea, Republic of
Jeong Won Jang Recruiting
Seoul, 동작구, Korea, Republic of, 06599
Contact: Jeong Won Jang, professor    821052049400    blackiqq@gmail.com   
Sponsors and Collaborators
Dong-Gun Lee
Investigators
Layout table for investigator information
Study Chair: Jeong Won Jang, Professor Seoul St. Mary's Hospital, the catholic university of Korea
Tracking Information
First Submitted Date  ICMJE June 15, 2021
First Posted Date  ICMJE June 29, 2021
Last Update Posted Date July 16, 2021
Estimated Study Start Date  ICMJE July 25, 2021
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2021) 		Comparison of the rate of HBV reactivation between the treatment and delayed treatment groups. [ Time Frame: The primary outcome is evaluated during 3 years after hematopoietic stem cell transplantation ]
Comparing the rate of HBV reactivation between the treatment and delayed treatment groups during 3 years after hematopoietic stem cell transplantation * Definition of HBV reactivation: HBsAg ≥ 1.0 S/CO or HBV DNA ≥ 10 IU/mL
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2021)
  • Comparison of the rate of active hepatitis with HBV reactivation between the treatment and delayed treatment groups. [ Time Frame: The secondary outcomes are evaluated during 3 years after hematopoietic stem cell transplantation. ]
    Comparing the rate of active hepatitis with HBV reactivation between the treatment and delayed treatment groups. * Definition of active hepatitis: ALT >= 2 times of upper normal limit
  • Comparison of the rate of hepatic failure related to HBV reactivation between the treatment and delayed treatment groups. [ Time Frame: The secondary outcomes are evaluated during 3 years after hematopoietic stem cell transplantation. ]
    Comparing the rate of hepatic failure between the treatment and delayed treatment groups.
  • Comparison of the rate of survival related to HBV reactivation between the treatment and delayed treatment groups. [ Time Frame: The secondary outcomes are evaluated during 3 years after hematopoietic stem cell transplantation. ]
    Comparing the rate of survival related to HBV reactivation between the treatment and delayed treatment groups.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prophylactic Entecavir for HBV Reactivation in Past HBV Infected Patients With Hematopoietic Stem Cell Transplantation
Official Title  ICMJE 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
Brief 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.
Detailed Description

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.

In this study, patients are randomized into treatment group or delayed treatment group.

* Stratified randomization (Block randomization within strata) according to the presence of HBsAb at baseline was used in this study.

  1. Experimental: Treatment group (n=82) The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after hematopoietic stem cell transplantation. The intervention group visit clinic every month and examined liver function test, HBsAg/Ab. HBV DNA level is examined at every 3 months.

    * oral administration of entecavir is planned to start within 7 days after hematopoietic stem cell transplantation.

  2. No Intervention: delayed treatment group (n=82) The delayed treatment group visit clinic every month and examined liver function test, HBsAg/Ab. HBV DNA level is examined at every 3 months. If the patient in the delayed treatment group shows HBV reactivation (positive HBsAg or HBV DNA ≥10 IU/mL), entecavir treatment is started.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatitis B Reactivation
  • Hematopoietic Stem Cell Transplantation
  • Antiviral Drug
  • HBV
Intervention  ICMJE Drug: Entecavir
The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after hematopoietic stem cell transplantation.
Other Name: Prophylactic treatment group
Study Arms  ICMJE
  • Experimental: Treatment group
    The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after hematopoietic stem cell transplantation. The intervention group visit clinic every month and examined liver function test, HBsAg/Ab. HBV DNA level is examined at every 3 months.
    Intervention: Drug: Entecavir
  • No Intervention: delayed treatment group
    The delayed treatment group visit clinic every month and examined liver function test, HBsAg/Ab. HBV DNA level is examined at every 3 months. If the patient in the delayed treatment group shows HBV reactivation (positive HBsAg or HBV DNA ≥10 IU/mL), entecavir treatment is started.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 20, 2021) 		164
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2025
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jeong Won Jang, Professor 82-10-5204-9400 garden@catholic.ac.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04942886
Other Study ID Numbers  ICMJE KC20MISI0622
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: According to the guideline of our institutional review board, the patient data could not be opened to other researchers.
Responsible Party Dong-Gun Lee, Seoul St. Mary's Hospital
Study Sponsor  ICMJE Dong-Gun Lee
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jeong Won Jang, Professor Seoul St. Mary's Hospital, the catholic university of Korea
PRS Account Seoul St. Mary's Hospital
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP