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

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