This trial is active, not recruiting.

Condition hepatic veno-occlusive disease
Treatment freeze-dried concentrated human antithrombin Ⅲ 500 iu
Phase phase 2
Sponsor Seoul National University Hospital
Start date June 2013
End date May 2016
Trial size 32 participants
Trial identifier NCT01886248, Antithrombin-III


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IU Units required (IU)/kg = 50 + [(desired-baseline AT-III level) x weight (kg) / 1.4]
freeze-dried concentrated human antithrombin Ⅲ 500 iu Antithrombin-III Human 500IU

Primary Outcomes

AT-III level before 5th dose of AT-III
time frame: up to 14 days

Secondary Outcomes

AT-III level before 9th dose
time frame: up to 14 days

Eligibility Criteria

Male or female participants up to 65 years old.

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

Additional Information

Official title Antithrombin-III for Patients With Hepatic Veno-occlusive Diseases Following Hematopoietic Stem Cell Transplantation
Principal investigator Hyoung Jin Kang, MD, Ph.D
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.