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

• Status: Active, not recruiting
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Antithrombin III; Antithrombins

Criteria

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