The UNBLOCK Study: Utilization of Bivalirudin On Clots in Kids

NCT00812370 | Completed Phase 1 DMC

• 1 other identifier: 3070850
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 6

Brief 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. 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.

Conditions

Deep Venous Thrombosis

Keywords

DVT; Deep Venous Thrombosis; UNBLOCK; Bivalirudin; Angiomax

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  twice a week until drug discontinuation

Study Arms (1)

open label

EXPERIMENTAL

Drug: Bivalirudin

Interventions

Bivalirudin DRUG

The initial bolus dose will be 0.125 mg/kg followed immediately by a continuous infusion of 0.125 mg/kg/hour.

Also known as: Angiomax

open label

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead
• Baylor College of Medicine: collaborator
• Children's Hospital Colorado: collaborator
• Children's Hospital of Philadelphia: collaborator
• Nationwide Children's Hospital: collaborator
• University of Texas Southwestern Medical Center: collaborator

Study Sites (6)

Childrens Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

UCD Hemophilia & Thrombosis Center

Aurora, Colorado, 80045, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 432005, United States

Location

The Childrens Hospital of Philidelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine/Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Venous Thrombosis

Interventions

bivalirudin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Guy A Young, MD

  CHLA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Hemostasis and Thrombosis Center

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 22, 2008
• Study Start: September 1, 2008
• Primary Completion: January 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 15, 2016

Record last verified: 2016-07

Locations

US (6)