Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants
25 januari 2012 bijgewerkt door: ZymoGenetics
A Phase 4, Open-Label, Single-Group Safety and Immunogenicity Study of RECOTHROM® (rThrombin) in Pediatric Subjects Undergoing Synchronous Burn Wound Excision and Skin Grafting
The objective of this study is to assess the safety and immunogenicity of recombinant thrombin (rThrombin) administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric patients, newborn through 17 years of age.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The safety, immunogenicity, and efficacy of rThrombin have been evaluated in 5 Phase 2 studies, 1 pivotal Phase 3 study, and 1 Phase 3b study, in surgical indications such as: spinal surgery, major hepatic resection, peripheral arterial bypass surgery, arteriovenous graft formation for hemodialysis access, and burn wound excision.
Limited data currently exist on the effects of rThrombin exposure in pediatric patients.
This Phase 4 trial aims to provide additional information on the use of rThrombin in children by evaluating the drug's safety and immunogenicity when administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric burn patients.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
30
Fase
- Fase 4
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85008
- Arizona Burn Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Niet ouder dan 17 jaar (Kind)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Age of newborn through 17 years at time of enrollment
- At least 1 skin graft recipient site measuring at least 1% of total body surface area (TBSA)
- Total initial burn wounds estimated to measure less than 40% of TBSA
- Bleeding indicating treatment with rThrombin during the surgical procedure
- Females of child-bearing potential must have a negative urine or serum pregnancy test within 2 days prior to study-drug treatment
- informed consent document signed by legal representative (guardian) and approved by an institutional review board/independent ethics committee (IRB/IEC)
- Participant has signed an IRB/IEC-approved pediatric assent document, if applicable
Exclusion Criteria:
- Gestational age younger than 36 weeks at birth (for infants younger than 2 years)
- Documented active infection at the graft recipient site (participants with resolved infections at potential graft recipient sites are not excluded)
- Acute inhalation injury, as defined by bronchoscopic evidence of lower airway injury
- Currently undergoing autologous skin grafting for ischemic ulcer disease or cutaneous malignancies
- Presence of antibodies or hypersensitivity to the study drug or any of its components, other thrombin preparations, or coagulation factors
- Transfusion of whole blood, fresh frozen plasma, cryoprecipitate, or platelets within 24 hours prior to study-drug treatment (packed red blood cell transfusions are allowed)
- History of HIV infection or other immunodeficiency syndrome or is taking immunosuppressive or antirejection medications
- Medical, social, or psychosocial factors that, in the opinion of the investigator, could affect safety or compliance with study procedures
- Breastfeeding or being breastfed
- Treatment with any experimental agent within 30 days of study enrollment or treatment
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Recombinant thrombin (rThrombin), 1000 IU/mL
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rThrombin,1000 IU/mL, 1000 IU/mL, applied topically to the bleeding site during a single surgery procedure on Day 1.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Number of Participants With Death, Serious Adverse Events, Treatment-related Adverse Events (AE), AEs Leading to Discontinuation, and AEs of Hypersensitivity
Tijdsspanne: Days 1 through 29, continuously
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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.
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.
Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment
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Days 1 through 29, continuously
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Number of Participants With AEs by Maximum Severity
Tijdsspanne: Days 1 through 29, continuously
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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.
Mild=asymptomatic or minor symptoms; intervention not indicated.
Moderate=requiring only minimal, local, or noninvasive intervention.
Severe=significant symptoms but not life-threatening; hospitalization or invasive intervention indicated.
Life-threatening=indicating intensive care or urgent invasive intervention.
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Days 1 through 29, continuously
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Number of Participants With Clinical Laboratory Findings of Grade O or Higher in Platelet, White Blood Cell (WBC), Lymphocyte, and Neutrophil Counts
Tijdsspanne: Baseline and Day 29 from Baseline
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Abnormal laboratory findings were recorded as AEs when considered clinically significant (unusual for the surgical population or individual participant) by the investigator, when associated with symptoms, when requiring specific treatment, or when requiring a change in participant management.LLN=lower level of normal.
Platelets: Grade 0=normal.
WBC: Grade 0=normal.
Lymphocytes: Grade 0=normal; Grade 1=<LLN x 0.8-10^9/L.
Neutrophils: Grade 0=normal; Grade 1=<LLN-1.5x10^9/L;
Grade 2=<1.5-1.0x10^9/L
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Baseline and Day 29 from Baseline
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Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Hemoglobin Levels
Tijdsspanne: Baseline and Day 29 from Baseline
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LLN=lower level of normal.
Grade 1=100 g/L to <LLN; Grade 2=80 to <100 g/L; Grade 3=65 to <80 g/L; Grade 4=<65 g/L.
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Baseline and Day 29 from Baseline
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Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Creatinine Levels
Tijdsspanne: Baseline and Day 29 from Baseline
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ULN=upper level of normal.
Grade 0=normal; Grade 1=>ULN to 1.5 x ULN.
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Baseline and Day 29 from Baseline
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Number of Participants With Elevations in the Coagulation Parameter of Activated Partial Thromboplastin Time (aPPT)of Grade 0 or Higher
Tijdsspanne: Baseline and Day 29 from Baseline
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ULN=upper limit of normal.
Grade 0=normal; Grade 1=ULN to 1.5 x ULN.
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Baseline and Day 29 from Baseline
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Number of Participants With a High International Normalized Ratio (INR) of Prothrombin Time of Grade 0 or Higher
Tijdsspanne: Baseline and Day 29 from Baseline
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Grade 0=normal.
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Baseline and Day 29 from Baseline
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Number of Participants WIth Positive Findings for Anti-rThrombin Product Antibody
Tijdsspanne: At Day 29
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Antibody-positive was defined as seroconversion or ≥1.0 unit (≥10-fold) increase in titer compared with antibody titer at baseline.
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At Day 29
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Kevin Foster, MD, Arizona Burn Center
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 maart 2009
Primaire voltooiing (Werkelijk)
1 januari 2010
Studie voltooiing (Werkelijk)
1 januari 2010
Studieregistratiedata
Eerst ingediend
9 maart 2009
Eerst ingediend dat voldeed aan de QC-criteria
10 maart 2009
Eerst geplaatst (Schatting)
11 maart 2009
Updates van studierecords
Laatste update geplaatst (Schatting)
26 januari 2012
Laatste update ingediend die voldeed aan QC-criteria
25 januari 2012
Laatst geverifieerd
1 januari 2012
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 499H01
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