Actively Recruiting
Long-Term Safety, Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria
Led by Omeros Corporation · Updated on 2024-03-07
25
Participants Needed
5
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the long-term safety and tolerability of repeat-dose OMS906 5 mg/kg IV administration at 8-week intervals in patients with PNH.
CONDITIONS
Official Title
Long-Term Safety, Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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.
- 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.
- Pregnant, planning to become pregnant, or nursing female patients.
- 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.
- Unable or unwilling to comply with the requirements of the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Omeros Investigational Site
Aachen, Germany
Not Yet Recruiting
2
Omeros Investigational Site
Ulm, Germany
Not Yet Recruiting
3
Omeros Investigational Site
Lausanne, Switzerland
Actively Recruiting
4
Omeros Investigational Site
Kyiv, Ukraine
Not Yet Recruiting
5
Omeros Investigational Site
Leeds, United Kingdom
Not Yet Recruiting
Research Team
O
Omeros Clinical Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here