NCT05095623

A Natural History Study to Assess the Clinical Outcomes of Patients With Complement Factor I Deficiency-Mediated Disease

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 3 (actual)
• Sponsor: Catalyst Biosciences · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

Summary

This study will follow participants with a disease which is associated with an absence or deficiency in Complement Factor I (CFI) as confirmed in the CFI-001 screening study.

Detailed description

This study will follow participants with a disease which is associated with an absence or deficiency in Complement Factor I (CFI) as confirmed in the CFI-001 screening study. The population will include male and female participants ≥6 months of age (pediatric participants enrolled as permitted by local Institutional Review Board/Independent Ethics Committee). This includes patients with recurrent bacterial infections (eg, meningitis, sepsis, pneumonia, endocarditis, otitis) and patients with autoimmune and immune complex-mediated diseases (eg, glomerulonephritis, systemic lupus erythematosus, leukocytoclastic vasculitis, Bickerstaff encephalitis, meningoencephalitis).

Conditions

• Recurrent Bacterial Infection, Autoimmune Disorder

Interventions

Type	Name	Description
OTHER	Natural History Observation	This is a natural history study.

Timeline

• Start date: 2021-08-31
• Primary completion: 2022-02-10
• Completion: 2022-02-10
• First posted: 2021-10-27
• Last updated: 2022-04-08

Locations

1 site across 1 country: United States