Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants
25 janvier 2012 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
30
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Arizona
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Phoenix, Arizona, États-Unis, 85008
- Arizona Burn Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
Pas plus vieux que 17 ans (Enfant)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants With Death, Serious Adverse Events, Treatment-related Adverse Events (AE), AEs Leading to Discontinuation, and AEs of Hypersensitivity
Délai: 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
|
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Number of Participants With AEs by Maximum Severity
Délai: 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.
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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
Délai: 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
Délai: 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.
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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
Délai: Baseline and Day 29 from Baseline
|
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
Délai: Baseline and Day 29 from Baseline
|
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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of Participants WIth Positive Findings for Anti-rThrombin Product Antibody
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Kevin Foster, MD, Arizona Burn Center
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mars 2009
Achèvement primaire (Réel)
1 janvier 2010
Achèvement de l'étude (Réel)
1 janvier 2010
Dates d'inscription aux études
Première soumission
9 mars 2009
Première soumission répondant aux critères de contrôle qualité
10 mars 2009
Première publication (Estimation)
11 mars 2009
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
26 janvier 2012
Dernière mise à jour soumise répondant aux critères de contrôle qualité
25 janvier 2012
Dernière vérification
1 janvier 2012
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 499H01
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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