CardiologyPhase 2NCT00503126
Bivalirudin as a Procedural Anticoagulant in Pediatrics
A Phase 2 study testing bivalirudin in people with Cardiology, run by The Medicines Company.
Trial summary
Pharmacokinetics and safety of weight based bivalirudin in children Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Cardiology
- What is being tested?
- bivalirudin
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Jul 2008
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and non-pregnant females, with an age range of birth to 16 years of age.
- Expected to undergo a percutaneous intravascular procedure for the management of congenital heart disease.
- Written informed consent from a legal guardian/parent.
- Life expectancy of at least 15 days at study entry.
- Assent of the patient if older than 8 years, whenever possible.
Who cannot join
- History of intracerebral bleed (neonates confirmed by an ultrasound head scan prior to procedure), or cerebral arteriovenous malformation or any prior bleed with neurological deficit.
- Gastrointestinal or genitourinary bleeding within the last 2 weeks excluding normal menstrual cycles.
- Cerebrovascular accident within 6 months, or any cerebrovascular accident with a residual neurological deficit.
- Known congenital or acquired bleeding or clotting disorder.
- Patients undergoing renal dialysis.*
- Weight < 2.5 kg.
Show all 14Show fewer
- Confirmed pregnancy at time of enrollment or breast feeding (females of child-bearing potential).
- Known allergy to bivalirudin or hirudin-derived drugs, or known sensitivity to any component of bivalirudin (Angiomax®).
- Any condition that in the investigator's opinion would constitute a contraindication to participation in the study, or cause inability to comply with the study requirements.
- Participation in another investigational therapeutic drug or therapeutic device trial within 30 days of starting study.
- Patients who have been receiving warfarin (Coumadin®) therapy and whose INR is > 1.5.
- Patients who cannot be discontinued from UFH at least 30 minutes prior to study drug bolus.
- Patients who have received a dose of LMWH within 8 hours prior to study drug bolus.
- Patients previously enrolled in the study.
About this study
Official title: Bivalirudin (Angiomax®) As A Procedural Anticoagulant In The Pediatric Population Undergoing Intravascular Procedures For Congenital Heart Disease
Pharmacokinetics and safety of weight based bivalirudin in children
- Conditions
- Cardiology
- Being tested
- bivalirudin
- Keywords
- pediatrics, bivalirudin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bivalirudinDrug
Also called Angiomax/Angiox
anticoagulation
What is being measured
The primary outcome is the main question the study is designed to answer.
PK/PD and safety
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study startAug 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CardiologyStudies 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Medicines Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503126
- Sponsor's protocol ID
- TMC-BIV-07-01
- Status last verified
- Nov 2011
- First submitted
- 16 Jul 2007
- Last updated
- 10 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Forbes TJ, Hijazi ZM, Young G, Ringewald JM, Aquino PM, Vincent RN, Qureshi AM, Rome JJ, Rhodes JF Jr, Jones TK, Moskowitz WB, Holzer RJ, Zamora R. Pediatric catheterization laboratory anticoagulation with bivalirudin. Catheter Cardiovasc Interv. 2011 Apr 1;77(5):671-9. doi: 10.1002/ccd.22817. Epub 2011 Jan 4.
PubMed 21433272
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bivalirudin (Angiomax®) As A Procedural Anticoagulant In The Pediatric Population Undergoing Intravascular Procedures For Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT00503126
- Acronym / sponsor ID
- TMC-BIV-07-01
- Conditions
- Cardiology
- Keywords
- pediatrics, bivalirudin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- The Medicines CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 18 Jul 2007 (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.
Pharmacokinetics and safety of weight based bivalirudin in children
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male and non-pregnant females, with an age range of birth to 16 years of age.
- Expected to undergo a percutaneous intravascular procedure for the management of congenital heart disease.
- Written informed consent from a legal guardian/parent.
- Life expectancy of at least 15 days at study entry.
- Assent of the patient if older than 8 years, whenever possible.
Key exclusion criteria (14 listed)
- History of intracerebral bleed (neonates confirmed by an ultrasound head scan prior to procedure), or cerebral arteriovenous malformation or any prior bleed with neurological deficit.
- Gastrointestinal or genitourinary bleeding within the last 2 weeks excluding normal menstrual cycles.
- Cerebrovascular accident within 6 months, or any cerebrovascular accident with a residual neurological deficit.
- Known congenital or acquired bleeding or clotting disorder.
- Patients undergoing renal dialysis.*
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 |
|---|---|---|
| bivalirudinAlso: Angiomax/Angioxanticoagulation | Drug | – |
Primary outcome
PK/PD and safety
Time frame: 30 days
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 10 Nov 2011.
- Derived from this study: PubMed 21433272Forbes TJ, Hijazi ZM, Young G, Ringewald JM, Aquino PM, Vincent RN, Qureshi AM, Rome JJ, Rhodes JF Jr, Jones TK, Moskowitz WB, Holzer RJ, Zamora R. Pediatric catheterization laboratory anticoagulation with bivalirudin. Catheter Cardiovasc Interv. 2011 Apr 1;77(5):671-9. doi: 10.1002/ccd.22817. Epub 2011 Jan 4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bivalirudin in people with Cardiology, run by The Medicines Company.
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 5 inclusion and 14 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 10 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
PK/PD and safety (time frame: 30 days). 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 NCT00503126, 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 10 Nov 2011.