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

March 28, 2021 updated by: Seoul National University Hospital
To evaluate efficacy and safety of AT-III treatment in patients with hepatic veno-occlusive diseases following hematopoietic stem cell transplantation.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Chongno-gu
      • Seoul, Chongno-gu, Korea, Republic of
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Antithrombin-III Human 500IU

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
Other Names:
  • Antithrombin-III Human 500IU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AT-III level before 5th dose of AT-III
Time Frame: up to 14 days
up to 14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
AT-III level before 9th dose
Time Frame: up to 14 days
up to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Hyoung Jin Kang, MD, Ph.D, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

May 30, 2013

First Submitted That Met QC Criteria

June 21, 2013

First Posted (Estimate)

June 25, 2013

Study Record Updates

Last Update Posted (Actual)

March 30, 2021

Last Update Submitted That Met QC Criteria

March 28, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Antithrombin-III

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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