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Antithrombin-III for Hepatic Veno-Occlusive Disease
NCT01886248Phase 2
Key facts
- Status
- Unknown
- Start
- Jun 2013
- Primary completion
- Aug 2021
- Countries
- 1
- Sponsor
- Seoul National University Hospital
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- antithrombin III
- Conditions
- hepatic veno-occlusive disease (HVOD)
01
Overview
Phase 2, open-label, single-arm trial of antithrombin III in hepatic veno-occlusive disease (HVOD), sponsored by Seoul National University Hospital. Primary endpoint: Antithrombin-III level up to 14 days. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Antithrombin-III Human 500IU
Freeze-dried Concentrated Human Antithrombin III 500 IU
03
Who it enrols
Patients with hepatic veno-occlusive disease after hematopoietic stem cell transplantation, defined by hyperbilirubinemia, hepatomegaly/pain, or weight gain, or pathologic diagnosis.
04
Endpoints
Primary
Antithrombin-III level
Secondary
Antithrombin-III level
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