Antithrombin Deficiency, CongenitalPhase 3rhATNCT00056550
Assess Incidence of Deep Vein Thrombosis(DVT)Following Administration of Recombinant Human Antithrombin (rhAT) to Hereditary Antithrombin(AT) Deficient Patients in High Risk Situations.
A Phase 3 study testing Recombinant Human Antithrombin (rhAT) in people with Antithrombin Deficiency, Congenital, run by rEVO Biologics at 11 sites in 6 countries.
Trial summary
Patients with hereditary antithrombin (AT) deficiency are at increased risk of venous thrombosis and pulmonary embolism, particularly during certain high risk procedures. The trial is focusing on patients with confirmed hereditary antithrombin deficiency who are undergoing a surgical procedure or induced/spontaneous… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Antithrombin Deficiency, Congenital
- What is being tested?
- Recombinant Human Antithrombin (rhAT)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 11 sitesin 6 countries
- Study dates
- Dec 2002to Feb 2004
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have congenital AT deficiency with a personal or family history of venous thrombotic events.
- Have a history of congenital AT deficiency that includes 2 or more plasma AT activity levels of ≤ 60% normal.
- Are scheduled to have an elective procedure known to be associated with a high risk for occurrence of Deep Venous Thrombosis (DVT). This will include surgical patients or pregnant patients scheduled for cesarean section or delivery induction. In addition, hospitalized pregnant HD patients in active labor will be allowed into the study.
- Are at least 18 years of age, not exceeding 70 years of age.
- Have signed an informed consent form.
- Have a negative serum pregnancy test at screening and negative urine pregnancy test at baseline. This only applies to female surgical patients (not scheduled for cesarean section) of childbearing potential.
- Are able to comply with the requirements of the study protocol.
Who cannot join
- Patients who have a diagnosis of hereditary APC resistance, Factor V Leiden, Protein S or C deficiency, prothrombin gene mutation (G20210A), or acquired (lupus anticoagulant) thrombophilic disorder.
- Patients who are scheduled for a neurosurgical procedure or open-heart surgery.
- Patients who have an underlying medical condition, which in the opinion of the investigator, could complicate the assessment of the incidence of DVT.
- Patients who have a known allergy to goats or goat products.
- Patients who have participated in a study employing an investigational drug within 30 days of the start of their participation in the current trial.
- Patients using fondaparinux sodium, or are expected to be treated with fondaparinux sodium during the study period.
Trial locations and contacts
11 sites in 6 countries.
11 sites in 6 countries
United States2 sites
Study site
Charleston, South Carolina
Study site
Marietta, Georgia
About this study
Official title: A Study to Assess the Incidence of Deep Vein Thrombosis (DVT) Following Prophylactic Intravenous Administration of Recombinant Human Antithrombin(rhAT) to Hereditary Antithrombin (AT) Deficient Patients in High Risk Situations.
Patients with hereditary antithrombin (AT) deficiency are at increased risk of venous thrombosis and pulmonary embolism, particularly during certain high risk procedures. The trial is focusing on patients with confirmed hereditary antithrombin deficiency who are undergoing a surgical procedure or induced/spontaneous labor and delivery. The study will test the safety and efficacy of recombinant human antithrombin (rhAT) by infusing rhAT prior to, during and following the period of risk or surgical procedure.
Read the detailed description
Objectives :
- Assess the safety of recombinant antithrombin (rhAT) in hereditary antithrombin (AT) deficient patients.
- Assess the incidence of acute deep venous thrombosis(DVT) alone in patients with hereditary antithrombin (AT) deficiency in situations usually associated with a high risk for thromboembolic events after increasing and targeting functional AT activity at >80% and < 120% of normal by prophylactic IV administration of rhAT.
- Clinically assess and determine the relevance of thromboembolic events other than acute DVT to rhAT administration.
- Conditions
- Antithrombin Deficiency, Congenital
- Being tested
- Recombinant Human Antithrombin (rhAT)
- Keywords
- Antithrombin Deficiency, Congenital, Antithrombin III Deficiency
- Medical subject headings
- Antithrombin III Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Antithrombin (rhAT)Biological
Also called ATryn
Biological/Vaccine: Recombinant human antithrombin(rhAT) Phase III clinical trial.
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Human Antithrombin (rhAT) infusion | Experimental | Loading and continuous infusion dose of rhAT to target and maintain an AT activity level > 80% and < 120% of normal. Receives: Biological: Recombinant Human Antithrombin (rhAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Vein Thrombosis (DVT).
Observation for clinical signs and symptoms of thromboembolic events are evaluated for acute deep vein thrombosis (DVT) using duplex ultrasonography and/or other imaging tests to confirm clinical signs/symptoms. Duplex ultrasonography was performed at baseline, last day of dosing and day 7 (+ or -1 day).
Measured: Baseline, last day of dosing and day 7 (+ or - 1 day)
Secondary outcomes (1)
Local Assessment of Thromboembolism by Physical Examination.
The investigators evaluated patients for any clinical signs of thromboembolism by physical examination.
Measured: 30 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2003 (estimated)
- Study startDec 2002
- Primary completionFeb 2004
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antithrombin Deficiency, CongenitalStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- rEVO Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cambell Tait, MD, Principal investigator, Royal Infirmary Glaskow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00056550
- Sponsor's protocol ID
- GTC AT III 01002
- Acronym
- rhAT
- Status last verified
- Aug 2012
- First submitted
- 17 Mar 2003
- Last updated
- 16 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
DeJongh J, Frieling J, Lowry S, Drenth HJ. Pharmacokinetics of recombinant human antithrombin in delivery and surgery patients with hereditary antithrombin deficiency. Clin Appl Thromb Hemost. 2014 May;20(4):355-64. doi: 10.1177/1076029613516188. Epub 2013 Dec 11.
PubMed 24335249
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Incidence of Deep Vein Thrombosis (DVT) Following Prophylactic Intravenous Administration of Recombinant Human Antithrombin(rhAT) to Hereditary Antithrombin (AT) Deficient Patients in High Risk Situations.
- ClinicalTrials.gov ID
- NCT00056550
- Acronym / sponsor ID
- rhAT / GTC AT III 01002
- Conditions
- Antithrombin Deficiency, Congenital
- Keywords
- Antithrombin Deficiency, Congenital, Antithrombin III Deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- rEVO BiologicsIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Feb 2004 (actual)
- Study completion
- Feb 2004 (actual)
- First posted
- 18 Mar 2003 (estimated)
- Results
- Posted 16 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with hereditary antithrombin (AT) deficiency are at increased risk of venous thrombosis and pulmonary embolism, particularly during certain high risk procedures. The trial is focusing on patients with confirmed hereditary antithrombin deficiency who are undergoing a surgical procedure or induced/spontaneous labor and delivery. The study will test the safety and efficacy of recombinant human antithrombin (rhAT) by infusing rhAT prior to, during and following the period of risk or surgical procedure.
Detailed description
Objectives :
- Assess the safety of recombinant antithrombin (rhAT) in hereditary antithrombin (AT) deficient patients.
- Assess the incidence of acute deep venous thrombosis(DVT) alone in patients with hereditary antithrombin (AT) deficiency in situations usually associated with a high risk for thromboembolic events after increasing and targeting functional AT activity at >80% and < 120% of normal by prophylactic IV administration of rhAT.
- Clinically assess and determine the relevance of thromboembolic events other than acute DVT to rhAT administration.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recombinant Human Antithrombin (rhAT) infusion | Experimental | Biological: Recombinant Human Antithrombin (rhAT)Loading and continuous infusion dose of rhAT to target and maintain an AT activity level > 80% and < 120% of normal. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have congenital AT deficiency with a personal or family history of venous thrombotic events.
- Have a history of congenital AT deficiency that includes 2 or more plasma AT activity levels of ≤ 60% normal.
- Are scheduled to have an elective procedure known to be associated with a high risk for occurrence of Deep Venous Thrombosis (DVT). This will include surgical patients or pregnant patients scheduled for cesarean section or delivery induction. In addition, hospitalized pregnant HD patients in active labor will be allowed into the study.
- Are at least 18 years of age, not exceeding 70 years of age.
- Have signed an informed consent form.
Key exclusion criteria (6 listed)
- Patients who have a diagnosis of hereditary APC resistance, Factor V Leiden, Protein S or C deficiency, prothrombin gene mutation (G20210A), or acquired (lupus anticoagulant) thrombophilic disorder.
- Patients who are scheduled for a neurosurgical procedure or open-heart surgery.
- Patients who have an underlying medical condition, which in the opinion of the investigator, could complicate the assessment of the incidence of DVT.
- Patients who have a known allergy to goats or goat products.
- Patients who have participated in a study employing an investigational drug within 30 days of the start of their participation in the current trial.
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 |
|---|---|---|
| Recombinant Human Antithrombin (rhAT)Also: ATrynBiological/Vaccine: Recombinant human antithrombin(rhAT) Phase III clinical trial. | Biological | Recombinant Human Antithrombin (rhAT) infusion |
Primary outcome
Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Vein Thrombosis (DVT).
Time frame: Baseline, last day of dosing and day 7 (+ or - 1 day)
Observation for clinical signs and symptoms of thromboembolic events are evaluated for acute deep vein thrombosis (DVT) using duplex ultrasonography and/or other imaging tests to confirm clinical signs/symptoms. Duplex ultrasonography was performed at baseline, last day of dosing and day 7 (+ or -1 day).
1 secondary outcome
Local Assessment of Thromboembolism by Physical Examination.
Time frame: 30 days after last dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24335249DeJongh J, Frieling J, Lowry S, Drenth HJ. Pharmacokinetics of recombinant human antithrombin in delivery and surgery patients with hereditary antithrombin deficiency. Clin Appl Thromb Hemost. 2014 May;20(4):355-64. doi: 10.1177/1076029613516188. Epub 2013 Dec 11.
- Additional information on hereditary antithrombin diseaseLink provided by the sponsor.
Related trials for Antithrombin Deficiency, Congenital
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Acquired Antithrombin Deficiency
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Belgian Antithrombin Deficiency Registry
Antithrombin III Deficiency
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.
Cambell Tait, MD principal investigator
Royal Infirmary Glaskow
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant Human Antithrombin (rhAT) in people with Antithrombin Deficiency, Congenital, run by rEVO Biologics at 11 sites in 6 countries.
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 6 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: finished, as of the sponsor's last update on 16 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, United States, France, United Kingdom, Italy and 1 more country. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Vein Thrombosis (DVT). (time frame: Baseline, last day of dosing and day 7 (+ or - 1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00056550, which also lists 1 linked publication.
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 16 Oct 2012.