- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01239706
Safety Study of Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Traumatic Brain Injury: Dosing Tier 1
A Phase IIa, Single Centre, Open Label Study to Characterize the Safety of Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Traumatic Brain Injury: Dosing Tier 1
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
Alberta
-
Calgary, Alberta, Canada, T2N2T9
- Recrutement
- Foothills Medical Center
-
Contact:
- Stephanie Todd, BSc, MBT, CCRP
- Numéro de téléphone: 403-944-3414
- E-mail: stephanie.todd@albertahealthservices.ca
-
Chercheur principal:
- David A Zygun, MD, MSc,
-
Sous-enquêteur:
- Andreas Kramer, MD, MSc
-
Sous-enquêteur:
- Clare Gallagher, MD, PhD
-
Sous-enquêteur:
- James Scott, MD, MSc
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Male and female patients age 18-65
- Written and informed consent from a legally acceptable representative
- Moderate to severe traumatic brain injury (TBI) defined as Glasgow Coma motor (GCSm) score ≤5, post resuscitation.
- Patient is <48hours from time of injury when the first dose of NTx™-265 is administered.
- Reasonable expectation of availability to receive the full 9 day course of therapy and be available for follow up evaluations
Female patient is either:
- Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral oophorectomy or hysterectomy) or
If of childbearing potential, would agree to use two of the following reliable methods of birth control throughout the study, including the follow-up visits:
- Condoms, sponge, foams, jellies, diaphragm or intrauterine device
- A vasectomised partner
- Abstinence
- Note: Hormonal Based contraceptives are NOT permissible as one of the two forms of contraceptives for this study.
Exclusion Criteria:
- Women who have been tested positive for pregnancy, or are breast-feeding or are not using a highly effective method of birth control that can be maintained for the duration of the study.
- Bilaterally fixed pupils
- Serum hemoglobin >160g/L (males) or >140g/L (female); or platelet count > 400,000/mm3
- Advanced cardiac, pulmonary, hepatic or liver disease; the former will be operationally defined using NCI Toxicity Criteria (Grade 2 or higher).
- Suspected anoxic or ischemic brain injury
- Known endocrine or germ cell tumor
- Serum billirubin > 1.5 x upper limit of normal (ULN).
- Alkaline Phosphatase > 2.5 x ULN
- AST and/or ALT > 2.5 x ULN
- Creatinine > 2.0 x ULN
- Patients with known or documented transferrin saturation < 20% or ferritin < 100ng/mL.
- Male patients with known and documented elevated PSA levels, or a PSA level of ≥4ng/mL at screening.
- Patients with known history or hypercoagulability, including known cardiolipin/antiphospholipid antibody syndrome.
Allergy or other contraindication to hCG including:
- Prior hypersensitivity to hCG preparations or one of their excipients.
- Primary ovarian failure.
- Uncontrolled thyroid or adrenal dysfunction.
- An uncontrolled organic intracranial lesion such as a pituitary tumor.
- Abnormal uterine bleeding of undetermined origin.
- Ovarian cyst or ovarian enlargement of undetermined origin.
- Sex hormone dependent tumors of the reproductive organs, accessory sex glands, and breasts.
Allergy or other contraindication to epoetin alfa:
- Who developed pure red cell aplasia following treatment with any erythropoiesis regulating hormones.
- With uncontrolled hypertension
- With known hypersensitivity to mammalian cell-derived products, albumin (human) or any component of the product
- Who for any reason cannot receive adequate antithrombotic treatment
- A known diagnosis of cancer (except basal cell cancer).
- Uncontrolled hypertension, defined as blood pressure persistently above 220 mm Hg systolic or 120 mm Hg diastolic despite antihypertensive therapy.
- Use of either hCG or epoetin alfa within the previous 90 days.
- Any condition known to elevate hCG, active in the prior 24 months e.g., choriocarcinoma or germ cell tumor.
- Any patients living in a nursing home or supervised living center. Patients must be historically fully independent in all activities of daily living including banking, shopping, cooking, toileting, showering and dressing.
- Any other medical condition, in the investigator's opinion, the patient should not be included in the trial.
- Patients who cannot take anti-platelet or anti-coagulant therapy.
- Pre-existing and active major psychiatric or other chronic Neurological disease.
- Patients who have a history of substance abuse or dependency within 12 months prior to the study.
- Currently participating in another investigational study
- Polytrauma defined as an Abbreviated Injury Severity Score >3 in any area other than head.
- Patients with evidence of an active or previous thrombotic event.
- Patients with contraindications to MRI scans
- Patients who are currently taking hormonal based contraceptives or hormonal replacement therapy in the past three (3) months.
Plan d'étude
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: NTx 265
|
10,000IU of hCG, every other day for three doses followed by 4000IU once daily for three days of erythropoietin
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Safety
Délai: 6 months
|
The primary endpoint for this study is safety. The following safety endpoints will be assessed:
|
6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Efficacy
Délai: 6 months
|
The following secondary endpoints will also be assessed in order to measure various aspects of neurological status:
|
6 months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: David A Zygun, MD, MSc, University of Calgary
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 23036
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 .
Essais cliniques sur Lésion cérébrale traumatique
-
Kessler FoundationInstituto Vocacional Enrique Díaz de León A.C., Guadalajara, MexicoRecrutementTBI (Traumatic Brain Injury) ou MS (Sclérose en Plaques)États-Unis, Espagne
Essais cliniques sur NTx 265
-
Stem Cell Therapeutics Corp.Retiré
-
University of Alabama at BirminghamRecrutementLeucémie myéloïde aiguë | Syndromes myélodysplasiques | Leucémie myélomonocytaire chroniqueÉtats-Unis
-
Major Extremity Trauma Research ConsortiumUnited States Department of DefenseRecrutementBlessures des nerfs périphériquesÉtats-Unis
-
Pinotbio, Inc.ComplétéVolontaires en bonne santéCorée, République de
-
Alkermes, Inc.Complété
-
Neuraptive Therapeutics Inc.Temporairement indisponibleTransections nerveuses périphériques, aiguës ou planifiées dans les nerfs des membres supérieurs et du visageÉtats-Unis
-
Neuraptive Therapeutics Inc.Résilié
-
Neuraptive Therapeutics Inc.Actif, ne recrute pasBlessures des nerfs périphériquesÉtats-Unis
-
Memorial Sloan Kettering Cancer CenterComplété
-
Vanderbilt University Medical CenterComplétéHypertension | Bradycardie | Tachycardie | Hypotension | DésaturationÉtats-Unis