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The objective of this study is to assess the immunogenicity and safety of recombinant Thrombin (rThrombin) in patients with prior rThrombin exposure.
The safety, immunogenicity, and efficacy of rThrombin have been evaluated in Phase 2 and Phase 3 studies in the following surgical indications: spinal surgery, major hepatic resection, peripheral arterial bypass (PAB) surgery, arteriovenous (AV) graft formation for hemodialysis access, and skin graft surgery following burn injury. Limited data on rThrombin reexposure currently exist. This study will assess the immunogenicity and safety of rThrombin in participants who are undergoing a surgical procedure during which topical rThrombin application is planned and who previously received rThrombin in Phase 3 clinical trials or during prior spine, AV graft formation, or PAB surgical procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rThrombin, 1000 IU/mL | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rThrombin, 1000 IU/mL | Biological | At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site, per product labeling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil Singla, MD | Lotus Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tuscon Orthopaedic Institute | Tuscon | Arizona | 85712 | United States |
Of 31 participants enrolled, all received treatment with recombinant thrombin (rThrombin).
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| ID | Title | Description |
|---|---|---|
| FG000 | rThrombin, 1000 IU/mL | At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | rThrombin, 1000 IU/mL | At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants who received treatment with rThrombin and had data available from both baseline and Day 29 antibody assessments. | Posted | Number | Participants | At baseline and Day 29 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TOTAL | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CHEST PAIN | General disorders | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Pribble, Vice President, Medical Affairs; Scot Maxon, Scientific Information | ZymoGenetics, a Bristol-Myers Squibb company | (206) 428-2756; (206) 434-3365 | John.Pribble@bms.com; Scot.Maxon@bms.com |
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| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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| ID | Term |
|---|---|
| C513462 | recombinant human thrombin |
| D013917 | Thrombin |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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|
| Baseline through Day 29, continuously |
| Number of Participants With AEs by Maximum Severity | 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. | Baseline to Day 29, continuously |
| Years |
|
| Age, Customized | Median | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Type of surgery | Number | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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 | 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. | All participants who received treatment with rThrombin. | Posted | Number | Participants | Baseline through Day 29, continuously |
|
|
|
| Secondary | Number of Participants With AEs by Maximum Severity | 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. | All participants who received treatment with rThrombin. | Posted | Number | Participants | Baseline to Day 29, continuously |
|
|
|
| 31 |
| 29 |
| 31 |
| OSTEOMYELITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| PROCEDURAL HYPOTENSION | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| RENAL FAILURE CHRONIC | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| ARTERIAL THROMBOSIS LIMB | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| PERIPHERAL ISCHAEMIA | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| TACHYCARDIA | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| ANAEMIA POSTOPERATIVE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| INCISION SITE PAIN | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| PROCEDURAL HYPOTENSION | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| HYPOAESTHESIA | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| RADICULOPATHY | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
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.
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
| Title | Measurements |
|---|---|
|
| AEs |
|
| Treatment-related AEs |
|
| AEs leading to discontinuation |
|
| Title | Measurements |
|---|
|
| Life-threatening |
|
| Fatal |
|