ThrombosisPhase 2NCT00043277
Study Of Angiomax In Infants Under Six Months With Thrombosis
A Phase 2 study testing Angiomax (bivalirudin) in people with Thrombosis, run by The Medicines Company at 1 site in United States.
Trial summary
The goals of this study are: 1. To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis; 2. To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (ACT) or activated partial thromboplastin time (aPTT) in… Read more about this study
- Who is it for?
- Ages 0 years to 6 months
- Conditions the study is for
- Thrombosis
- What is being tested?
- Angiomax (bivalirudin)
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Dec 2004
- 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 0 years to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parent/legal-guardian has provided written informed consent before initiation of any study related procedures.
- Objectively confirmed thrombotic event by either doppler ultrasound, echocardiogram, CT scan, MRI, MR angiogram, MR venogram, venogram or arteriogram.
- Age less than 6 months .
- Gestational age greater than 35 weeks
- Expected life expectancy at least 14 days.
- No contraindication to anticoagulation i.e. bleeding complications.
Who cannot join
- Active or recent (less than 7 days) bleeding.
- Known allergy to Angiomax or hirudin, or known sensitivity to any component of the product.
- Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment.
- Refusal to undergo blood transfusion should it become necessary.
- Any other disease or condition, which, in the judgment of the Investigator would place a patient at undue risk by being enrolled in the trial.
- Baseline prolonged PT (>18 secs) or aPTT (>55 secs)
Show all 10Show fewer
- Platelet count < 50,000 cells/mm3
- Birth Trauma
- Planned or indicated surgery within 30 days
- Major or minor bleeding event
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Orange County
Orange, California, 92868
About this study
Official title: Pilot Dose Finding And Efficacy Study Of Angiomax® (Bivalirudin) As Primary Anticoagulation In Infants Under Six Months With Thrombosis
The goals of this study are:
- To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis;
- To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (ACT) or activated partial thromboplastin time (aPTT) in Infants Under Six Months with arterial or venous thrombosis;
- To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (UH) or low molecular weight heparin (LMWH).
Read the detailed description
The goals of this study are:
- To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis;
- To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (ACT) or activated partial thromboplastin time (aPTT) in Infants Under Six Months with arterial or venous thrombosis;
- To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (UH) or low molecular weight heparin (LMWH).
- Conditions
- Thrombosis
- Being tested
- Angiomax (bivalirudin)
- Keywords
- neonates, thrombosis, bivalirudin, direct thrombin inhibitor
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiomax (bivalirudin)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Observation of improvement for thrombosis or by clinical exam such as: Decrease in size of thrombus, restoration of flow through an occluded vessel, decrease in diameter of extremity or head.
Secondary outcomes (1)
In addition, efficacy will also be judged by demonstrating a decrease in the molecular markers of thrombin generation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2002 (estimated)
- Study startAug 2002
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- The Medicines Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Guy Young, MD, Principal investigator, Children's Hospital Orange County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00043277
- Sponsor's protocol ID
- TMC-BIV-02-04
- Status last verified
- Jan 2006
- First submitted
- 7 Aug 2002
- Last updated
- 1 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Dose Finding And Efficacy Study Of Angiomax® (Bivalirudin) As Primary Anticoagulation In Infants Under Six Months With Thrombosis
- ClinicalTrials.gov ID
- NCT00043277
- Acronym / sponsor ID
- TMC-BIV-02-04
- Conditions
- Thrombosis
- Keywords
- neonates, thrombosis, bivalirudin, direct thrombin inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- The Medicines CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Study completion
- Dec 2004
- First posted
- 8 Aug 2002 (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.
The goals of this study are:
- To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis;
- To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (ACT) or activated partial thromboplastin time (aPTT) in Infants Under Six Months with arterial or venous thrombosis;
- To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (UH) or low molecular weight heparin (LMWH).
Detailed description
The goals of this study are:
- To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis;
- To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (ACT) or activated partial thromboplastin time (aPTT) in Infants Under Six Months with arterial or venous thrombosis;
- To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (UH) or low molecular weight heparin (LMWH).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Parent/legal-guardian has provided written informed consent before initiation of any study related procedures.
- Objectively confirmed thrombotic event by either doppler ultrasound, echocardiogram, CT scan, MRI, MR angiogram, MR venogram, venogram or arteriogram.
- Age less than 6 months .
- Gestational age greater than 35 weeks
- Expected life expectancy at least 14 days.
Key exclusion criteria (10 listed)
- Active or recent (less than 7 days) bleeding.
- Known allergy to Angiomax or hirudin, or known sensitivity to any component of the product.
- Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment.
- Refusal to undergo blood transfusion should it become necessary.
- Any other disease or condition, which, in the judgment of the Investigator would place a patient at undue risk by being enrolled in the 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 |
|---|---|---|
| Angiomax (bivalirudin) | Drug | – |
Primary outcome
Observation of improvement for thrombosis or by clinical exam such as: Decrease in size of thrombus, restoration of flow through an occluded vessel, decrease in diameter of extremity or head.
1 secondary outcome
In addition, efficacy will also be judged by demonstrating a decrease in the molecular markers of thrombin generation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2006.
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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.
Guy Young, MD principal investigator
Children's Hospital Orange County
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 Angiomax (bivalirudin) in people with Thrombosis, run by The Medicines Company at 1 site in United States.
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 6 inclusion and 10 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 1 Feb 2006. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Observation of improvement for thrombosis or by clinical exam such as: Decrease in size of thrombus, restoration of flow through an occluded vessel, decrease in diameter of extremity or head.. 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 1 Feb 2006.