Trial Outcomes & Findings for Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis (NCT NCT00813904)
NCT ID: NCT00813904
Last Updated: 2011-12-08
Results Overview
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.
COMPLETED
PHASE4
31 participants
At baseline and Day 29
2011-12-08
Participant Flow
Of 31 participants enrolled, all received treatment with recombinant thrombin (rThrombin).
Participant milestones
| Measure |
rThrombin, 1000 IU/mL
At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
rThrombin, 1000 IU/mL
At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
|
|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis
Baseline characteristics by cohort
| Measure |
rThrombin, 1000 IU/mL
n=31 Participants
At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
|
|---|---|
|
Age, Customized
|
59.5 Years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Age, Customized
Median
|
61.0 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Type of surgery
Arterial reconstruction/peripheral arterial bypass
|
4 Participants
n=5 Participants
|
|
Type of surgery
Arteriovenous vascular access procedure
|
3 Participants
n=5 Participants
|
|
Type of surgery
Other
|
1 Participants
n=5 Participants
|
|
Type of surgery
Spinal
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At baseline and Day 29Population: Participants who received treatment with rThrombin and had data available from both baseline and Day 29 antibody assessments.
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.
Outcome measures
| Measure |
rThrombin, 1000 IU/mL
n=30 Participants
At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
|
|---|---|
|
Number or Participants With Antirecombinant Thrombin (rThrombin) Product Antibody at Baseline and Day 29
Baseline
|
0 Participants
|
|
Number or Participants With Antirecombinant Thrombin (rThrombin) Product Antibody at Baseline and Day 29
Day 29
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline through Day 29, continuouslyPopulation: All participants who received treatment with rThrombin.
An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.
Outcome measures
| Measure |
rThrombin, 1000 IU/mL
n=31 Participants
At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
|
|---|---|
|
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
AEs
|
29 Participants
|
|
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
Death
|
1 Participants
|
|
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
SAEs
|
6 Participants
|
|
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
Treatment-related SAEs
|
0 Participants
|
|
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
Treatment-related AEs
|
0 Participants
|
|
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
AEs leading to discontinuation
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 29, continuouslyPopulation: All participants who received treatment with rThrombin.
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. AE severity was assessed using Common Terminology Criteria for Adverse Events, Version 13.0: Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening; Grade 5=fatal.
Outcome measures
| Measure |
rThrombin, 1000 IU/mL
n=31 Participants
At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
|
|---|---|
|
Number of Participants With AEs by Maximum Severity
Mild
|
1 Participants
|
|
Number of Participants With AEs by Maximum Severity
Moderate
|
18 Participants
|
|
Number of Participants With AEs by Maximum Severity
Severe
|
9 Participants
|
|
Number of Participants With AEs by Maximum Severity
Life-threatening
|
0 Participants
|
|
Number of Participants With AEs by Maximum Severity
Fatal
|
1 Participants
|
Adverse Events
TOTAL
Serious adverse events
| Measure |
TOTAL
n=31 participants at risk
|
|---|---|
|
General disorders
CHEST PAIN
|
3.2%
1/31
|
|
Infections and infestations
OSTEOMYELITIS
|
3.2%
1/31
|
|
Infections and infestations
SEPSIS
|
3.2%
1/31
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
3.2%
1/31
|
|
Injury, poisoning and procedural complications
PROCEDURAL HYPOTENSION
|
3.2%
1/31
|
|
Nervous system disorders
SYNCOPE
|
3.2%
1/31
|
|
Renal and urinary disorders
RENAL FAILURE
|
3.2%
1/31
|
|
Renal and urinary disorders
RENAL FAILURE CHRONIC
|
3.2%
1/31
|
|
Vascular disorders
ARTERIAL THROMBOSIS LIMB
|
3.2%
1/31
|
|
Vascular disorders
HYPOTENSION
|
3.2%
1/31
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
3.2%
1/31
|
Other adverse events
| Measure |
TOTAL
n=31 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
6.5%
2/31
|
|
Cardiac disorders
TACHYCARDIA
|
19.4%
6/31
|
|
Gastrointestinal disorders
CONSTIPATION
|
25.8%
8/31
|
|
Gastrointestinal disorders
NAUSEA
|
25.8%
8/31
|
|
Gastrointestinal disorders
VOMITING
|
6.5%
2/31
|
|
General disorders
PYREXIA
|
9.7%
3/31
|
|
Injury, poisoning and procedural complications
ANAEMIA POSTOPERATIVE
|
19.4%
6/31
|
|
Injury, poisoning and procedural complications
INCISION SITE PAIN
|
16.1%
5/31
|
|
Injury, poisoning and procedural complications
PROCEDURAL HYPOTENSION
|
9.7%
3/31
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
74.2%
23/31
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
6.5%
2/31
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
19.4%
6/31
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
6.5%
2/31
|
|
Nervous system disorders
HYPOAESTHESIA
|
6.5%
2/31
|
|
Nervous system disorders
RADICULOPATHY
|
6.5%
2/31
|
|
Psychiatric disorders
INSOMNIA
|
12.9%
4/31
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
6.5%
2/31
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
6.5%
2/31
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
6.5%
2/31
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
12.9%
4/31
|
|
Vascular disorders
HYPERTENSION
|
6.5%
2/31
|
Additional Information
John Pribble, Vice President, Medical Affairs; Scot Maxon, Scientific Information
ZymoGenetics, a Bristol-Myers Squibb company
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER