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

NCT01886248 | Unknown Phase 2

• 1 other identifier: Antithrombin-III
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatic Veno-Occlusive Disease

Keywords

hepatic veno-occlusive disease after hematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• AT-III level before 5th dose of AT-III

  up to 14 days

Secondary Outcomes (1)

• AT-III level before 9th dose

  up to 14 days

Study Arms (1)

Antithrombin-III Human 500IU

EXPERIMENTAL

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

Drug: Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IU

Interventions

Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IU DRUG

Also known as: Antithrombin-III Human 500IU

Antithrombin-III Human 500IU

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with hepatic veno-occlusive disease after hematopoietic stem cell transplantation. The following criteria will be used.
• 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
• Patients with pathologic diagnosis.
• Patients with informed consent

You may not qualify if:

• Pregnant or nursing women.
• Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
• Psychiatric disorder that would preclude compliance.
• Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
• History of anaphylactic reaction to the study drug

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Chongno-gu, South Korea

Location

MeSH Terms

Conditions

Hepatic Veno-Occlusive Disease

Interventions

Antithrombin III

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Antithrombin Proteins; Serpins; Peptides; Amino Acids, Peptides, and Proteins; Alpha-Globulins; Serum Globulins; Blood Proteins; Proteins; Globulins; Blood Coagulation Factor Inhibitors; Biological Factors

Study Officials

• Hyoung Jin Kang, MD, Ph.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: June 25, 2013
• Study Start: June 1, 2013
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: March 30, 2021

Record last verified: 2021-03

Locations

KR (1)