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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2021-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Hepatic Veno-Occlusive Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Antithrombin-III Human 500IU

Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IU

Units required (IU)/kg = 50 + \[(desired-baseline AT-III level) x weight (kg) / 1.4\]

Group Type EXPERIMENTAL

Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IU

Intervention Type DRUG

Interventions

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Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IU

Intervention Type DRUG

Other Intervention Names

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Antithrombin-III Human 500IU

Eligibility Criteria

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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

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No