Deep Venous ThrombosisPhase 1UNBLOCKNCT00812370
The UNBLOCK Study: Utilization of Bivalirudin On Clots in Kids
A Phase 1 study testing Bivalirudin in people with Deep Venous Thrombosis, run by Children's Hospital Los Angeles at 6 sites in United States.
Trial summary
Thrombosis is a significant medical complication in children with chronic diseases. The currently utilized treatments have many drawbacks which can lead to poor outcomes. More modern therapies are available but have not been systematically tested in children. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Deep Venous Thrombosis
- What is being tested?
- Bivalirudin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2008to Jul 2013
- Phase
- Phase 1
- 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children > 6 months to < 18 years of age.
- Deep vein thrombosis demonstrated by objective testing (Duplex ultrasonography, venography, CT venography, MR venography, echocardiography). This imaging must be performed within 72 hours prior to initiation of study drug if no other anticoagulation has been started. If receiving other anticoagulation prior to start of study drug, imaging must be performed within 24 hours of study drug initiation.
- Informed consent and assent from parent/guardian/patient
Who cannot join
- Treatment of present thrombus with thrombolytic agent.
- Treatment of present thrombus with another anticoagulant for more than 48 hours (low dose heparin for maintenance of venous or arterial catheter patency is allowed).
- Baseline prothrombin time (PT) which is more than 3 seconds above the upper limit of normal or baseline activated partial thromboplastin time (aPTT) which is more than 5 seconds above the upper limit of normal.
- Creatinine which is more than 20% above the upper limit of normal for age.
- Presence of a known bleeding disorder.
- Active bleeding.
- Planned invasive procedure within 3 days.
- Known pregnancy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
UCD Hemophilia & Thrombosis Center
Aurora, Colorado, 80045
Nationwide Children's Hospital
Columbus, Ohio, 432005
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, 77030
Childrens Hospital Los Angeles
Los Angeles, California, 90027
The Childrens Hospital of Philidelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: An Open-label, Dose-finding, Pharmacokinetic, Safety and Efficacy Study of Bivalirudin in Children Between 6 Months and 18 Years of Age
Thrombosis is a significant medical complication in children with chronic diseases. The currently utilized treatments have many drawbacks which can lead to poor outcomes. More modern therapies are available but have not been systematically tested in children. This study will determine whether one such medication, bivalirudin is a safer and more effective alterative.
This study will monitor what effects the drug has upon the child's body and how the body processes the study drug (absorption, metabolism and elimination). The study will also evaluate the drug's effectiveness by following how long it takes to dissolve the clot. The safety issues being monitored relate to any observations of major or minor bleeding episodes after taking the drug, and/or any other side effects.
Read the detailed description
This will be an open-label, single-arm, dose-finding, pharmacokinetic, safety and efficacy study of bivalirudin in children 6 months to 18 years of age with deep vein thrombosis. The specific aims are as follows:
- Pharmacodynamic analysis based on the activated partial thromboplastin time (aPTT) will be performed and the best bolus dose and initial infusion dose of bivalirudin will be determined for 3 age cohorts of children.
- Pharmacokinetic analysis of bivalirudin will be determined based on bivalirudin plasma levels in the same 3 age cohorts.
- Comparison of pharmacokinetics with pharmacodynamics will be performed to determine whether the aPTT is an adequate surrogate for plasma bivalirudin levels.
- The rate of clot resolution within 48-72 hours will be determined.
- The safety of bivalirudin will be determined by assessing for major and minor bleeding and other adverse events.
A total of 30 patients will be enrolled in this study. They will be divided into 3 groups according to their age range (6 months-age to > 5, 5 to > 12 years and 12 to >18 years). The patient must have a deep vein thrombosis (clot in an artery or vein) that has been seen on an imaging test. After receiving the study drug, the subjects will then have blood tests at specific timepoints to measure how the drug is effecting the body and how the drug is acting once it is in the body. Based upon the levels of the blood tests, the dose of the study drug may be adjusted or stopped. The subject will continue on the drug until the clot is dissolved, the subject is prescribed a different anticoagulant or the physician or parents decide to remove the child off of the study. The drug will also be discontinued if any excessive bleeding or severe side effects related to the drug are observed. A follow up imaging study will be performed on all patients 48-72 hours after the drug was started. If the clot is still present at this time, another imaging study will be done at 30 days after the drug was given. The subjects will continue to have lab tests twice weekly for about 3 weeks to monitor for the effects of the drug. After completion of the study, the patient will undergo a study exit physical exam between 20-40 days after the drug was stopped.
- Conditions
- Deep Venous Thrombosis
- Being tested
- Bivalirudin
- Keywords
- DVT, Deep Venous Thrombosis, UNBLOCK, Bivalirudin, Angiomax
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BivalirudinDrug
Also called Angiomax
The initial bolus dose will be 0.125 mg/kg followed immediately by a continuous infusion of 0.125 mg/kg/hour.
| Study group | Role | What they receive |
|---|---|---|
| open label | Experimental | Not described Receives: Drug: Bivalirudin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The study will assess efficacy by re-evaluating thrombus at 48-72 hours as well as continued efficacy by re-evaluating the thrombus at ~30 days after study drug initiation.
Measured: 30 days
Secondary outcomes (1)
Pharmacokinetics (PK) will also be assessed by measuring plasma bivalirudin levels and correlation of the PD to the PK parameter will be performed. The study will also assess safety by evaluating for bleeding, as well as other adverse events.
Measured: twice a week until drug discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startSep 2008
- Primary completionJan 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine, Children's Hospital Colorado, Children's Hospital of Philadelphia, Nationwide Children's Hospital, University of Texas Southwestern Medical Center
- Responsible party
- Principal investigator, Guy Young, Children's Hospital Los Angeles
- Investigators
- Guy A Young, MD, Principal investigator, CHLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812370
- Sponsor's protocol ID
- 3070850
- Acronym
- UNBLOCK
- Status last verified
- Jul 2016
- First submitted
- 18 Dec 2008
- Last updated
- 15 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Dose-finding, Pharmacokinetic, Safety and Efficacy Study of Bivalirudin in Children Between 6 Months and 18 Years of Age
- ClinicalTrials.gov ID
- NCT00812370
- Acronym / sponsor ID
- UNBLOCK / 3070850
- Conditions
- Deep Venous Thrombosis
- Keywords
- DVT, Deep Venous Thrombosis, UNBLOCK, Bivalirudin, Angiomax
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- Baylor College of Medicine, Children's Hospital Colorado, Children's Hospital of Philadelphia, Nationwide Children's Hospital, University of Texas Southwestern Medical Center
- Study start
- Sep 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 22 Dec 2008 (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.
Thrombosis is a significant medical complication in children with chronic diseases. The currently utilized treatments have many drawbacks which can lead to poor outcomes. More modern therapies are available but have not been systematically tested in children. This study will determine whether one such medication, bivalirudin is a safer and more effective alterative.
This study will monitor what effects the drug has upon the child's body and how the body processes the study drug (absorption, metabolism and elimination). The study will also evaluate the drug's effectiveness by following how long it takes to dissolve the clot. The safety issues being monitored relate to any observations of major or minor bleeding episodes after taking the drug, and/or any other side effects.
Detailed description
This will be an open-label, single-arm, dose-finding, pharmacokinetic, safety and efficacy study of bivalirudin in children 6 months to 18 years of age with deep vein thrombosis. The specific aims are as follows:
- Pharmacodynamic analysis based on the activated partial thromboplastin time (aPTT) will be performed and the best bolus dose and initial infusion dose of bivalirudin will be determined for 3 age cohorts of children.
- Pharmacokinetic analysis of bivalirudin will be determined based on bivalirudin plasma levels in the same 3 age cohorts.
- Comparison of pharmacokinetics with pharmacodynamics will be performed to determine whether the aPTT is an adequate surrogate for plasma bivalirudin levels.
- The rate of clot resolution within 48-72 hours will be determined.
- The safety of bivalirudin will be determined by assessing for major and minor bleeding and other adverse events.
A total of 30 patients will be enrolled in this study. They will be divided into 3 groups according to their age range (6 months-age to > 5, 5 to > 12 years and 12 to >18 years). The patient must have a deep vein thrombosis (clot in an artery or vein) that has been seen on an imaging test. After receiving the study drug, the subjects will then have blood tests at specific timepoints to measure how the drug is effecting the body and how the drug is acting once it is in the body. Based upon the levels of the blood tests, the dose of the study drug may be adjusted or stopped. The subject will continue on the drug until the clot is dissolved, the subject is prescribed a different anticoagulant or the physician or parents decide to remove the child off of the study. The drug will also be discontinued if any excessive bleeding or severe side effects related to the drug are observed. A follow up imaging study will be performed on all patients 48-72 hours after the drug was started. If the clot is still present at this time, another imaging study will be done at 30 days after the drug was given. The subjects will continue to have lab tests twice weekly for about 3 weeks to monitor for the effects of the drug. After completion of the study, the patient will undergo a study exit physical exam between 20-40 days after the drug was stopped.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open label | Experimental | Drug: Bivalirudin |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children > 6 months to < 18 years of age.
- Deep vein thrombosis demonstrated by objective testing (Duplex ultrasonography, venography, CT venography, MR venography, echocardiography). This imaging must be performed within 72 hours prior to initiation of study drug if no other anticoagulation has been started. If receiving other anticoagulation prior to start of study drug, imaging must be performed within 24 hours of study drug initiation.
- Informed consent and assent from parent/guardian/patient
Key exclusion criteria (8 listed)
- Treatment of present thrombus with thrombolytic agent.
- Treatment of present thrombus with another anticoagulant for more than 48 hours (low dose heparin for maintenance of venous or arterial catheter patency is allowed).
- Baseline prothrombin time (PT) which is more than 3 seconds above the upper limit of normal or baseline activated partial thromboplastin time (aPTT) which is more than 5 seconds above the upper limit of normal.
- Creatinine which is more than 20% above the upper limit of normal for age.
- Presence of a known bleeding disorder.
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: AngiomaxThe initial bolus dose will be 0.125 mg/kg followed immediately by a continuous infusion of 0.125 mg/kg/hour. | Drug | open label |
Primary outcome
The study will assess efficacy by re-evaluating thrombus at 48-72 hours as well as continued efficacy by re-evaluating the thrombus at ~30 days after study drug initiation.
Time frame: 30 days
1 secondary outcome
Pharmacokinetics (PK) will also be assessed by measuring plasma bivalirudin levels and correlation of the PD to the PK parameter will be performed. The study will also assess safety by evaluating for bleeding, as well as other adverse events.
Time frame: twice a week until drug discontinuation
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 15 Jul 2016.
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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 A Young, MD principal investigator
CHLA
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bivalirudin in people with Deep Venous Thrombosis, run by Children's Hospital Los Angeles at 6 sites 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 3 inclusion and 8 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 15 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study will assess efficacy by re-evaluating thrombus at 48-72 hours as well as continued efficacy by re-evaluating the thrombus at ~30 days after study drug initiation. (time frame: 30 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 15 Jul 2016.