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

Hepatic Veno-Occlusive Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01886248
• Other study ID #: Antithrombin-III
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 2013
• Est. completion date: August 2021

Study information

• Verified date: March 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatic Veno-Occlusive Disease

Intervention

Drug:
• Freeze-dried Concentrated Human Antithrombin ? 500 IU

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Chongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AT-III level before 5th dose of AT-III		up to 14 days
Secondary	AT-III level before 9th dose		up to 14 days