NCT00813904

Brief Summary

The objective of this study is to assess the immunogenicity and safety of recombinant Thrombin (rThrombin) in patients with prior rThrombin exposure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 23, 2008

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 8, 2011

Completed
Last Updated

December 8, 2011

Status Verified

November 1, 2011

Enrollment Period

1.5 years

First QC Date

December 19, 2008

Results QC Date

November 3, 2011

Last Update Submit

November 3, 2011

Conditions

Blood Loss, Surgical

Outcome Measures

Primary Outcomes (1)

  • Number or Participants With Antirecombinant Thrombin (rThrombin) Product Antibody at Baseline and Day 29

    Immunogenicity of rThrombin product was evaluated using an enzyme-linked immunosorbent assay for detection of antirThrombin product antibody and a neutralizing antibody assay to characterize the potential of antibodies to rThrombin product to neutralize the activity of human plasma-derived thrombin.

    At baseline and Day 29

Secondary Outcomes (2)

  • Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Adverse Events (AEs), Treatment-related Adverse Events, and AEs Leading to Discontinuation

    Baseline through Day 29, continuously

  • Number of Participants With AEs by Maximum Severity

    Baseline to Day 29, continuously

Study Arms (1)

rThrombin, 1000 IU/mL

EXPERIMENTAL
Biological: rThrombin, 1000 IU/mL

Interventions

rThrombin, 1000 IU/mLBIOLOGICAL

At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site, per product labeling.

Also known as: RECOTHROM
rThrombin, 1000 IU/mL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previous enrollment in a ZymoGenetics-sponsored Phase 3 study and the recipient of treatment with rThrombin in that study or the recipient of commercially-available rThrombin in a prior spine, arteriovenous graft formation, or peripheral artery bypass surgical procedure
  • Age of 18 years or older at time of consent
  • Bleeding indicating treatment with rThrombin during the course of the surgical procedure
  • Signed informed consent document approved by an institutional review board or independent ethics committee

You may not qualify if:

  • Currently undergoing a procedure requiring cardiopulmonary bypass or involving the aortic arch
  • Known hypersensitivity to rThrombin product or any of its components
  • Currently undergoing a surgical procedure where the use of other thrombin-containing hemostatic agents is planned
  • Medical, social, or psychosocial factors that, in the opinion of the investigator, could affect the participant's safety or compliance with study procedures
  • Treatment with any experimental agent within 30 days of study enrollment or treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tuscon Orthopaedic Institute

Tuscon, Arizona, 85712, United States

Location

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

recombinant human thrombinThrombin

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative Complications

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBiological Factors

Results Point of Contact

Title
John Pribble, Vice President, Medical Affairs; Scot Maxon, Scientific Information
Organization
ZymoGenetics, a Bristol-Myers Squibb company
John.Pribble@bms.com; Scot.Maxon@bms.com
(206) 428-2756; (206) 434-3365

Study Officials

  • Neil Singla, MD

    Lotus Clinical Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2008

First Posted

December 23, 2008

Study Start

January 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

December 8, 2011

Results First Posted

December 8, 2011

Record last verified: 2011-11

Locations

US(1)