Safety and Pharmacokinetics of TT30 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Stopped early · Phase 1

Conditions studied: Paroxysmal Nocturnal Hemoglobinuria (PNH)

In brief

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.

Key facts

Study ID

NCT01335165

Run by

Alexion Pharmaceuticals, Inc.

People needed

10

Starts

2011-04-01

Expected to finish

2014-03-01

Last updated by the study team

2014-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals at least 18 years of age with a diagnosis of PNH \& vaccination against meningococcus.

You may not qualify if…

• 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

Where it is running

• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Institute of Hematology and Blood Transfusion / Institut Hematologie a krevní transfuze — U Nemocnice 1, Prague 2, Czechia
• Federico II University of Naples — Via Pansini 5, Naples, Italy
• University Clinical Centre — Dębinki, Gdańsk, Poland
• King's College Hospital NHS Foundation Trust — Denmark Hill, London, United Kingdom

Full record on ClinicalTrials.gov

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