Overview
Safety and Pharmacokinetics of TT30 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Status:
Terminated
Terminated
Trial end date:
2014-03-01
2014-03-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this research study is to understand the safety, pharmacokinetics and pharmacodynamics of a single dose of TT30 (ALXN1102 and ALXN1103 formulations) when given IV (through a vein) or SC (under the skin) to patients with PNH.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Alexion Pharmaceuticals
Criteria
Inclusion Criteria:- Individuals at least 18 years of age with a diagnosis of PNH & vaccination against
meningococcus.
Exclusion Criteria:
- Abnormal renal or liver function
- History of meningococcal disease
- History of Guillain-Barre syndrome
- Known infection with HIV or Hepatitis B or C
- History of thrombotic events