- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00859547
Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants
25. januar 2012 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
30
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Arizona
-
Phoenix, Arizona, Forenede Stater, 85008
- Arizona Burn Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
Ikke ældre end 17 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Recombinant thrombin (rThrombin), 1000 IU/mL
|
rThrombin,1000 IU/mL, 1000 IU/mL, applied topically to the bleeding site during a single surgery procedure on Day 1.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With Death, Serious Adverse Events, Treatment-related Adverse Events (AE), AEs Leading to Discontinuation, and AEs of Hypersensitivity
Tidsramme: Days 1 through 29, continuously
|
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
|
Days 1 through 29, continuously
|
Number of Participants With AEs by Maximum Severity
Tidsramme: Days 1 through 29, continuously
|
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.
|
Days 1 through 29, continuously
|
Number of Participants With Clinical Laboratory Findings of Grade O or Higher in Platelet, White Blood Cell (WBC), Lymphocyte, and Neutrophil Counts
Tidsramme: Baseline and Day 29 from Baseline
|
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
|
Baseline and Day 29 from Baseline
|
Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Hemoglobin Levels
Tidsramme: Baseline and Day 29 from Baseline
|
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.
|
Baseline and Day 29 from Baseline
|
Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Creatinine Levels
Tidsramme: Baseline and Day 29 from Baseline
|
ULN=upper level of normal.
Grade 0=normal; Grade 1=>ULN to 1.5 x ULN.
|
Baseline and Day 29 from Baseline
|
Number of Participants With Elevations in the Coagulation Parameter of Activated Partial Thromboplastin Time (aPPT)of Grade 0 or Higher
Tidsramme: Baseline and Day 29 from Baseline
|
ULN=upper limit of normal.
Grade 0=normal; Grade 1=ULN to 1.5 x ULN.
|
Baseline and Day 29 from Baseline
|
Number of Participants With a High International Normalized Ratio (INR) of Prothrombin Time of Grade 0 or Higher
Tidsramme: Baseline and Day 29 from Baseline
|
Grade 0=normal.
|
Baseline and Day 29 from Baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants WIth Positive Findings for Anti-rThrombin Product Antibody
Tidsramme: At Day 29
|
Antibody-positive was defined as seroconversion or ≥1.0 unit (≥10-fold) increase in titer compared with antibody titer at baseline.
|
At Day 29
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Kevin Foster, MD, Arizona Burn Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2009
Primær færdiggørelse (Faktiske)
1. januar 2010
Studieafslutning (Faktiske)
1. januar 2010
Datoer for studieregistrering
Først indsendt
9. marts 2009
Først indsendt, der opfyldte QC-kriterier
10. marts 2009
Først opslået (Skøn)
11. marts 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
26. januar 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. januar 2012
Sidst verificeret
1. januar 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 499H01
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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