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

Phase 2

• Conditions: Hepatic Veno-Occlusive Disease
• Interventions: Drug: Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IU

• Registration Number: NCT01886248
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-30
• Study Start: 2013-06
• Study First Submitted QC: 2013-06-21
• Study First Posted: 2013-06-25
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-28
• Last Update Posted: 2021-03-30
• Primary Completion: 2021-08
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Antithrombin-III Human 500IU	Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IU	Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IU Units required (IU)/kg = 50 + \[(desired-baseline AT-III level) x weight (kg) / 1.4\]

Primary Outcome Measures

Name	Time	Method
AT-III level before 5th dose of AT-III	up to 14 days

Secondary Outcome Measures

Name	Time	Method
AT-III level before 9th dose	up to 14 days

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Chongno-gu, Korea, Republic of