Status:
UNKNOWN
Antithrombin-III for Patients With Hepatic Veno-occlusive Diseases Following Hematopoietic Stem Cell Transplantation
Lead Sponsor:
Seoul National University Hospital
Conditions:
Hepatic Veno-Occlusive Disease
Eligibility:
All Genders
Up to 65 years
Phase:
PHASE2
Brief Summary
To evaluate efficacy and safety of AT-III treatment in patients with hepatic veno-occlusive diseases following hematopoietic stem cell transplantation.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01886248
Start Date
June 1 2013
End Date
August 1 2021
Last Update
March 30 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Seoul National University Hospital
Seoul, Chongno-gu, South Korea