Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

ZymoGenetics

ClinicalTrials.gov Identifier:

NCT00859547

First received: March 9, 2009

Last updated: January 25, 2012

Last verified: January 2012

History of Changes

Results First Received: November 3, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Blood Loss, Surgical
Intervention:	Biological: rThrombin, 1000 IU/mL

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Of the 32 participants who signed informed consent in this study, 30 were actually enrolled and received treatment with rThrombin.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
rThrombin, 1000 IU/mL	Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.

Participant Flow: Overall Study

	rThrombin, 1000 IU/mL
STARTED	30
COMPLETED	28
NOT COMPLETED	2
Lost to Follow-up	1
Parent withdrew consent	1

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
rThrombin, 1000 IU/mL	Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.

Baseline Measures

	rThrombin, 1000 IU/mL
Number of Participants [units: participants]	30
Age, Customized [units: participants]
0-2 years	11
3-6 years	8
7-11 years	3
12-17 years	8
Gender [units: participants]
Female	12
Male	18
Race/Ethnicity, Customized [units: participants]
American Indian/Alaskan native	1
Black or African American	6
Hispanic	9
White	14

Outcome Measures

Show All Outcome Measures

1. Primary:

Number of Participants With Death, Serious Adverse Events, Treatment-related Adverse Events (AE), AEs Leading to Discontinuation, and AEs of Hypersensitivity [ Time Frame: Days 1 through 29, continuously ]

Show Outcome Measure 1

2. Primary:

Number of Participants With AEs by Maximum Severity [ Time Frame: Days 1 through 29, continuously ]

Show Outcome Measure 2

3. Primary:

Number of Participants With Clinical Laboratory Findings of Grade O or Higher in Platelet, White Blood Cell (WBC), Lymphocyte, and Neutrophil Counts [ Time Frame: Baseline and Day 29 from Baseline ]

Show Outcome Measure 3

4. Primary:

Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Hemoglobin Levels [ Time Frame: Baseline and Day 29 from Baseline ]

Show Outcome Measure 4

5. Primary:

Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Creatinine Levels [ Time Frame: Baseline and Day 29 from Baseline ]

Show Outcome Measure 5

6. Primary:

Number of Participants With Elevations in the Coagulation Parameter of Activated Partial Thromboplastin Time (aPPT)of Grade 0 or Higher [ Time Frame: Baseline and Day 29 from Baseline ]

Show Outcome Measure 6

7. Primary:

Number of Participants With a High International Normalized Ratio (INR) of Prothrombin Time of Grade 0 or Higher [ Time Frame: Baseline and Day 29 from Baseline ]

Show Outcome Measure 7

8. Secondary:

Number of Participants WIth Positive Findings for Anti-rThrombin Product Antibody [ Time Frame: At Day 29 ]

Show Outcome Measure 8

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Hide Other Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
TOTAL	No text entered.

Other Adverse Events

	TOTAL
Total, other (not including serious) adverse events
# participants affected / at risk	28/30
Blood and lymphatic system disorders
ANAEMIA ^{† 1}
# participants affected / at risk	9/30 (30.00%)
Gastrointestinal disorders
CONSTIPATION ^{† 1}
# participants affected / at risk	2/30 (6.67%)
VOMITING ^{† 1}
# participants affected / at risk	2/30 (6.67%)
General disorders
OEDEMA PERIPHERAL ^{† 1}
# participants affected / at risk	2/30 (6.67%)
PYREXIA ^{† 1}
# participants affected / at risk	3/30 (10.00%)
Immune system disorders
TRANSPLANT REJECTION ^{† 1}
# participants affected / at risk	3/30 (10.00%)
Infections and infestations
BACTERAEMIA ^{† 1}
# participants affected / at risk	2/30 (6.67%)
SKIN GRAFT INFECTION ^{† 1}
# participants affected / at risk	2/30 (6.67%)
Injury, poisoning and procedural complications
PROCEDURAL PAIN ^{† 1}
# participants affected / at risk	15/30 (50.00%)
SEROMA ^{† 1}
# participants affected / at risk	2/30 (6.67%)
SKIN GRAFT FAILURE ^{† 1}
# participants affected / at risk	2/30 (6.67%)
WOUND SECRETION ^{† 1}
# participants affected / at risk	2/30 (6.67%)
Skin and subcutaneous tissue disorders
EXCESSIVE GRANULATION TISSUE ^{† 1}
# participants affected / at risk	2/30 (6.67%)
PRURITUS ^{† 1}
# participants affected / at risk	13/30 (43.33%)
Vascular disorders
HAEMATOMA ^{† 1}
# participants affected / at risk	2/30 (6.67%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 13.1

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: ZymoGenetics (ZG) agreements vary by trial, but each states that presentation/publication (p/p) cannot disclose Confidential Information (CI), excluding trial results; p/p may not begin until the earlier of 18 months after study end, ZG/lead investigator publishes, or ZG notification that multicenter publication is not planned; ZG has specified time for draft review before submission/presentation and may delay or modify content, require CI removal, and delay p/p for patent application filing.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: John Pribble, Vice President, Medical Affairs; Scot Maxon, Scientific Information
Organization: ZymoGenetics
phone: (206) 428-2756; (206) 434-3365
e-mail: John.Pribble@bms.com; Scot.Maxon@bms.com

No publications provided by ZymoGenetics

Publications automatically indexed to this study:

Foster KN, Mullins RF, Greenhalgh DG, Gamelli RL, Glat P, Lentz CW, Kahn SA, Brandigi C, Fredlund P, Alexander WA. Recombinant human thrombin: safety and immunogenicity in pediatric burn wound excision. J Pediatr Surg. 2011 Oct;46(10):1992-9.

Responsible Party:	ZymoGenetics
ClinicalTrials.gov Identifier:	NCT00859547 History of Changes
Other Study ID Numbers:	499H01
Study First Received:	March 9, 2009
Results First Received:	November 3, 2011
Last Updated:	January 25, 2012
Health Authority:	United States: Institutional Review Board

To Top