Antithrombin-III for Patients With Hepatic Veno-occlusive Diseases Following Hematopoietic Stem Cell Transplantation
Primary Purpose
Hepatic Veno-Occlusive Disease
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IU
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Veno-Occlusive Disease focused on measuring hepatic veno-occlusive disease after hematopoietic stem cell transplantation
Eligibility Criteria
Inclusion Criteria:
Patients with hepatic veno-occlusive disease after hematopoietic stem cell transplantation. The following criteria will be used.
Two of the following
- Serum total bilirubin > 2.0 mg/dL
- Hepatomegaly or right upper quadrant pain of liver origin
- Unexplained weight gain of>2% over baseline because of fluid accumulation
- Patients with pathologic diagnosis.
- Patients with informed consent
Exclusion Criteria:
- Pregnant or nursing women.
- Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
- Psychiatric disorder that would preclude compliance.
- Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
- History of anaphylactic reaction to the study drug
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Antithrombin-III Human 500IU
Arm Description
Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IU Units required (IU)/kg = 50 + [(desired-baseline AT-III level) x weight (kg) / 1.4]
Outcomes
Primary Outcome Measures
AT-III level before 5th dose of AT-III
Secondary Outcome Measures
AT-III level before 9th dose
Full Information
NCT ID
NCT01886248
First Posted
May 30, 2013
Last Updated
March 28, 2021
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01886248
Brief Title
Antithrombin-III for Patients With Hepatic Veno-occlusive Diseases Following Hematopoietic Stem Cell Transplantation
Official Title
Antithrombin-III for Patients With Hepatic Veno-occlusive Diseases Following Hematopoietic Stem Cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate efficacy and safety of AT-III treatment in patients with hepatic veno-occlusive diseases following hematopoietic stem cell transplantation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Veno-Occlusive Disease
Keywords
hepatic veno-occlusive disease after hematopoietic stem cell transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Antithrombin-III Human 500IU
Arm Type
Experimental
Arm Description
Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IU
Units required (IU)/kg = 50 + [(desired-baseline AT-III level) x weight (kg) / 1.4]
Intervention Type
Drug
Intervention Name(s)
Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IU
Other Intervention Name(s)
Antithrombin-III Human 500IU
Primary Outcome Measure Information:
Title
AT-III level before 5th dose of AT-III
Time Frame
up to 14 days
Secondary Outcome Measure Information:
Title
AT-III level before 9th dose
Time Frame
up to 14 days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with hepatic veno-occlusive disease after hematopoietic stem cell transplantation. The following criteria will be used.
Two of the following
Serum total bilirubin > 2.0 mg/dL
Hepatomegaly or right upper quadrant pain of liver origin
Unexplained weight gain of>2% over baseline because of fluid accumulation
Patients with pathologic diagnosis.
Patients with informed consent
Exclusion Criteria:
Pregnant or nursing women.
Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
Psychiatric disorder that would preclude compliance.
Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
History of anaphylactic reaction to the study drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyoung Jin Kang, MD, Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Chongno-gu
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Antithrombin-III for Patients With Hepatic Veno-occlusive Diseases Following Hematopoietic Stem Cell Transplantation
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