Hepatic Veno-Occlusive Disease
Conditions
Keywords
hepatic veno-occlusive disease after hematopoietic stem cell transplantation
Brief summary
To evaluate efficacy and safety of AT-III treatment in patients with hepatic veno-occlusive diseases following hematopoietic stem cell transplantation.
Interventions
DRUGFreeze-dried Concentrated Human Antithrombin Ⅲ 500 IU
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with hepatic veno-occlusive disease after hematopoietic stem cell transplantation. The following criteria will be used. 1. 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 2. Patients with pathologic diagnosis. 2. Patients with informed consent
Exclusion criteria
1. Pregnant or nursing women. 2. Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy. 3. Psychiatric disorder that would preclude compliance. 4. Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study. 5. History of anaphylactic reaction to the study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AT-III level before 5th dose of AT-III | up to 14 days |
Secondary
| Measure | Time frame |
|---|---|
| AT-III level before 9th dose | up to 14 days |
Countries
South Korea
Outcome results
None listed