Antithrombin-III for Patients With Hepatic Veno-occlusive Diseases Following Hematopoietic Stem Cell Transplantation

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Seoul National University

Status and phase

Unknown
Phase 2

Conditions

Hepatic Veno-Occlusive Disease

Treatments

Drug: Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IU

Study type

Interventional

Funder types

Other

Identifiers

NCT01886248
Antithrombin-III

Details and patient eligibility

About

To evaluate efficacy and safety of AT-III treatment in patients with hepatic veno-occlusive diseases following hematopoietic stem cell transplantation.

Enrollment

32 estimated patients

Sex

All

Ages

Under 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

32 participants in 1 patient group

Antithrombin-III Human 500IU
Experimental group
Description:
Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IU Units required (IU)/kg = 50 + [(desired-baseline AT-III level) x weight (kg) / 1.4]
Treatment:
Drug: Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IU

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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