Safety and Efficacy Study of Intravenous Uricase-PEG 20
Açar sözlər
Mücərrəd
Təsvir
Uricase is an enzyme (found in most mammals but not humans) that converts poorly soluble uric acid into highly soluble allantoin. Because humans lack uricase, they are prone to develop elevated levels of uric acid, which can form crystals in the joints and soft tissues. In those which chronically elevated uric acid, gout may develop. In the setting of acute rises in uric acid, seen for example in tumor lysis syndrome, uric acid crystals can damage the renal tubules. Uricase-PEG 20 is a recombinant uricase conjugated with multiple PEG molecules designed to prolong the half-life and decrease the immunogenicity of uricase. This study will characterize the safety, pharmacokinetics and pharmacodynamics of intravenous Uricase-PEG 20, the anticipated route of administration to be used in future clinical development in tumor lysis syndrome.
Tarixlər
| Son Doğrulandı: | 01/31/2010 |
| İlk təqdim: | 11/23/2009 |
| Təxmini qeydiyyat təqdim edildi: | 11/23/2009 |
| İlk Göndərmə: | 11/25/2009 |
| Son Yeniləmə Göndərildi: | 02/21/2010 |
| Son Yeniləmə Göndərildi: | 02/22/2010 |
| Həqiqi Təhsilin Başlama Tarixi: | 09/30/2009 |
| Təxmini İlkin Tamamlanma Tarixi: | 02/28/2010 |
| Təxmini İşin Tamamlanma Tarixi: | 02/28/2010 |
Vəziyyət və ya xəstəlik
Müdaxilə / müalicə
Biological: Uricase-PEG 20
Faza
Qol Qrupları
| Qol | Müdaxilə / müalicə |
|---|---|
| Experimental: Uricase-PEG 20 Cohorts will receive ascending doses of Uricase-PEG 20 in a sequential manner | Biological: Uricase-PEG 20 Intravenous infusion of Uricase-PEG 20 over one hour; no premedication |
Uyğunluq Kriteriyaları
| Təhsil üçün uyğun yaşlar | 40 Years Üçün 40 Years |
| Təhsilə Uyğun Cinslər | All |
| Sağlam Könüllüləri qəbul edir | Bəli |
| Kriteriyalar | Inclusion Criteria: - Serum uric acid > 6 mg/dL (men) or > 5 mg/dL (women) - Clinical laboratory values within normal limits or not clinically significant - Women should be menopausal or peri-menopausal Exclusion Criteria: - Prior exposure to uricase - History of severe allergic reactions, or any allergy to PEG or pegylated products - G6PD or catalase deficiency - Medical condition that may interfere with ability to complete the study (e.g., uncontrolled diabetes or hypertension, congestive heart failure NYHA Class III or IV, history of myocardial infarction, immunosuppression, pregnancy) |
Nəticə
İlkin nəticə tədbirləri
1. Safety (assessment of signs and symptoms and clinical laboratory measurements following administration of Uricase-PEG 20, graded according to the Common Toxicity Criteria for Rheumatology, version 2.0) [Through Day 35 after dosing]
2. Pharmacokinetics (Uricase-PEG 20 serum concentration) [Through Day 35 after dosing]
3. Pharmacodynamics (plasma uric acid concentration) [Through Day 35 after dosing]
