Hepatic Veno-Occlusive DiseasePhase 2NCT01886248
Antithrombin-III for Patients With Hepatic Veno-occlusive Diseases Following Hematopoietic Stem Cell Transplantation
A Phase 2 study testing Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IU in people with Hepatic Veno-Occlusive Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To evaluate efficacy and safety of AT-III treatment in patients with hepatic veno-occlusive diseases following hematopoietic stem cell transplantation. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Hepatic Veno-Occlusive Disease
- What is being tested?
- Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to Aug 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IU
- Keywords
- hepatic veno-occlusive disease after hematopoietic stem cell transplantation
- Medical subject headings
- Hepatic Veno-Occlusive Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IUDrug
Also called Antithrombin-III Human 500IU
| Study group | Role | What they receive |
|---|---|---|
| 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] Receives: Drug: Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IU |
What is being measured
The primary outcome is the main question the study is designed to answer.
AT-III level before 5th dose of AT-III
Measured: up to 14 days
Secondary outcomes (1)
AT-III level before 9th dose
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Veno-Occlusive DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hyoung Jin Kang, MD, Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886248
- Sponsor's protocol ID
- Antithrombin-III
- Status last verified
- Mar 2021
- First submitted
- 30 May 2013
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antithrombin-III for Patients With Hepatic Veno-occlusive Diseases Following Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT01886248
- Acronym / sponsor ID
- Antithrombin-III
- Conditions
- Hepatic Veno-Occlusive Disease
- Keywords
- hepatic veno-occlusive disease after hematopoietic stem cell transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 25 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate efficacy and safety of AT-III treatment in patients with hepatic veno-occlusive diseases following hematopoietic stem cell transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antithrombin-III Human 500IU | Experimental | Drug: Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IUFreeze-dried Concentrated Human Antithrombin Ⅲ 500 IU Units required (IU)/kg = 50 + [(desired-baseline AT-III level) x weight (kg) / 1.4] |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with hepatic veno-occlusive disease after hematopoietic stem cell transplantation. The following criteria will be used.
- Patients with informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IUAlso: Antithrombin-III Human 500IU | Drug | Antithrombin-III Human 500IU |
Primary outcome
AT-III level before 5th dose of AT-III
Time frame: up to 14 days
1 secondary outcome
AT-III level before 9th dose
Time frame: up to 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyoung Jin Kang, MD, Ph.D principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IU in people with Hepatic Veno-Occlusive Disease, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AT-III level before 5th dose of AT-III (time frame: up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.