Long-Term Safety, Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria

Más betegség

• History of any severe hypersensitivity reactions to other monoclonal antibodies or excipients included in the OMS906 preparation.
• Patients with unresolved serious infections caused by encapsulated bacteria including H. influenzae, S. pneumoniae and N. meningitidis.
• History of any significant medical, neurologic, or psychiatric disorder that in the opinion of the investigator would make the patient unsuitable for participation in the long-term extension.

Laborértékek

• Platelet count <30,000/µL or absolute neutrophil count <500 cells/µL at the start of the Evaluation Period.
• Elevation of liver function tests, defined as total bilirubin > 2 x ULN, direct bilirubin > 1.5 x ULN, and elevated transaminases (alanine or aspartate aminotransferase), > 2 X ULN unless due to PNH-related hemolysis.

Egyéb

• Pregnant, planning to become pregnant, or nursing female patients.
• Unable or unwilling to comply with the requirements of the study.

• Have completed the last dosing visit of the prior OMS906 PNH study.
• Female patients of child bearing potential must have a negative result from a highly sensitive urine pregnancy test prior to each dose of OMS906.
• Females must use highly effective birth control to prevent pregnancy during the clinical trial and for 20 weeks following their last dose of study drug.
• Males must use highly effective birth control with a female partner to prevent pregnancy during the clinical trial and for 20 weeks after last dose of study drug.
• Have current vaccination status for Neisseria meningitidis, Streptococcus pneumonia and Hemophilus influenza and agree to maintain vaccination throughout the study.
• Have provided informed consent