An Open Label Single and Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-17299425 in Patients with Traumatic Brain Injury.

Janssen-Cilag International N.V0 个研究点开始时间: 2007年4月23日最近更新: 2012年3月19日

研究概览

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•Subjects with traumatic head injury (GCS: greater than or equal to 8/15 before ventilation) and requiring ventilation and intra-cranial pressure monitoring.
•Male or female between 18 and 65 years of age, inclusive.
•Female subjects: post menopausal as defined by FSH and LH, or previously documented sterilization.
•Legally acceptable representatives (relatives/guardians) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are allowing the subject to participate in the study.
•Moderately increased ICP (ICP>20 mmHG and CPP greater than or equal to 60mmHg) after initial response to <20mmHg), to a maximum of 3 ventricular drainages.
•HB greater than or equal to 8 g/dL.
•Thrombocytes count greater than or equal to 100.000/microLiters.
•Potassium less than or equal to 5mmol/L.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years)
•F.1.3.1 Number of subjects for this age range

•Major injury (multitrauma) or disease outside the CNS causing significant vital organ- or blood counts dysfunction (eg Disseminated Intravascular Coagulation (DIC), serious hepatic or kidney failure, (Acute Respiratory Distress Syndrome (ARDS) etc.).
•Subjects who already received specific ICP lowering therapy, other than drainage, before being dosed with JNJ-17299425.
•Rapid increase of ICP expected to result in death of the subject.
•Relevant abnormal values for hematology, clinical chemistry or urinalysis at screening. In particular, a significant abnormal hematology profile, or unacceptable bleeding diathesis.
•Any known significant history or family history of anemia, hemolytic or otherwise, or autoimmune disease.
•Significant non-brain trauma.
•On CT scan, compressive hematoma and more than 2 cm midline shift resulting into cranial surgery, or other features that would make the need for surgery unlikely.
•Any unknown significant history or family history of thrombocytopenia (eg idiopathic thrombocytopenia).

发起方