Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis

NCT00491608 | Completed Phase 3 Results

• 1 other identifier: 499F04
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and immune system response to recombinant thrombin when used to control bleeding in spinal and vascular surgery.

Conditions

Spinal Surgery; Vascular Surgery

Keywords

Phase 3b; rThrombin; spine surgery; vascular surgery; hemostasis; immunogenicity; safety

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Anti-recombinant Thrombin (rThrombin) Product Antibodies at Day 29 in Participants With and Without Anti-bovine Thrombin Product Antibodies at Baseline

  Seropositive=with specific anti-bovine thrombin product antibodies; seronegative=without specific anti-bovine thrombin product antibodies.

  At Day 29

Secondary Outcomes (5)

• Number of Participants With Death as Outcome, Serious Adverse Events, Treatment-related Adverse Events (AEs), and Treatment-emergent AEs

  Day 1 (surgery) to Day 29 (end of study), continuously

• Number of Participants With Abnormal Hematology Laboratory Results of Common Terminology Criteria (CTC) Grade 2 or Higher at Baseline and Day 29

  Baseline and Day 29 (end of study)

• Number of Participants With Elevations in Coagulation Parameters of CTC Grade 3 or Higher at Baseline and Day 29

  Baseline and Day 29 (end of study)

• Number of Participants With Abnormal Laboratory Results in Median Levels of Immunoglobulin A, G, and M at Baseline or Day 29

  Baseline and Day 29 (end of study)

• Number of Participants With Clinically Significant Changes in Mean Values for Vital Signs (Temperature, Systolic Blood Pressure, Diastolic Blood Pressure, Respiration Rate, Heart Rate) at Baseline and Day 29

  Baseline and Day 29 (end of study)

Study Arms (1)

1

EXPERIMENTAL

rThrombin

Biological: rThrombin

Interventions

rThrombin BIOLOGICAL

1000 U/mL applied directly or in combination with absorbable gelatin sponge or powder

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently undergoing cervical, thoracic, or lumbar discectomy; corpectomy, laminectomy, lateral or interbody fusion, including both anterior and posterior approaches (not including minimally invasive procedures; arterial reconstruction; peripheral artery bypass (PAB) grafting; or arteriovenous (AV) vascular access procedures
• History of surgery with high likelihood of exposure to bovine thrombin within the past 3 years. Prior surgery must have been 1 of the following open procedures: open procedures involving the spine or cranium, PAB grafting, AV vascular access procedures, autologous skin grafting, or other surgical procedure accompanied by documented treatment with bovine thrombin
• Age of 18 years or younger at time of informed consent
• If female and of child-bearing potential: Negative pregnancy test result within 14 days prior to treatment
• Use of a medically accepted form of contraception from the time of informed consent to completion of all follow-up study visits, if sexually active male or a sexually active female of childbearing potential
• Signed IRB/independent ethics committee-approved informed consent document

You may not qualify if:

• Currently undergoing procedures requiring cardiopulmonary bypass or involving the aortic arch
• Known hypersensitivity to rThrombin or any of its components
• Presence of medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures
• Breastfeeding
• Receipt of treatment with any experimental agent within 30 days of study enrollment or treatment

Sponsors & Collaborators

• ZymoGenetics: lead

Study Sites (1)

Huntington Memorial Hospital

Pasadena, California, 91105, United States

Location

Related Publications (2)

• Randleman CD Jr, Singla NK, Renkens KL, Souza S, Pribble JP, Alexander WA. Persistence of antibodies to the topical hemostat bovine thrombin. J Am Coll Surg. 2010 Dec;211(6):798-803. doi: 10.1016/j.jamcollsurg.2010.07.023. Epub 2010 Oct 25.

  PMID: 20980172 DERIVED

• Singla NK, Ballard JL, Moneta G, Randleman CD Jr, Renkens KL, Alexander WA. A phase 3b, open-label, single-group immunogenicity and safety study of topical recombinant thrombin in surgical hemostasis. J Am Coll Surg. 2009 Jul;209(1):68-74. doi: 10.1016/j.jamcollsurg.2009.03.016. Epub 2009 May 28.

  PMID: 19651065 DERIVED

MeSH Terms

Interventions

recombinant human thrombin

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

• Allan Alexander, MD, CPI

  ZymoGenetics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2007
• First Posted: June 26, 2007
• Study Start: June 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: January 13, 2012
• Results First Posted: January 12, 2012

Record last verified: 2012-01

Locations

US (1)