Screening Study to Identify Patients With Complement Factor I Deficiencies

Catalyst Biosciences

Status: Terminated

Conditions: Previous Diagnosis With a Complement-mediated Disease and/or With Clinical Manifestations Reasonably Associated With Complement Factor I Deficiency

Study type: Observational

Funder types: Industry

Identifiers

NCT05072912

CFI-001

Details and patient eligibility

About

This is screening study to identify patients with Complement Factor I deficiencies. The primary objective is to identify participants with CFI deficiencies and assess the prevalence in the screened population.

Enrollment: 113 patients

Sex: All

Ages: 6+ months old

Volunteers: No Healthy Volunteers

Inclusion criteria

An individual must meet all the following criteria to be eligible to participate in this study:

1. A male or female ≥6 months of age who has been diagnosed with a complement-mediated disease in which a reasonable etiological association with CFI deficiency has been reported
2. Affirmation of participant's informed consent or LAR's willingness to provide informed consent with signature confirmation before any study-related activities. (Study-related activities are any procedures that would not have been performed during normal clinical management of the participant.) The participant (if a minor) must be willing to give written informed assent if the minor is within the age groups 7 to 11 years old and 12 to 17 years old.

Exclusion criteria

1. Diagnosis of age-related macular degeneration that is complement-related with no concurrent systemic complement involvement