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

Stopped early

Conditions studied: Recurrent Bacterial Infection, Autoimmune Disorder

In brief

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.

Key facts

Study ID

NCT05095623

Run by

Catalyst Biosciences

People needed

3

Starts

2021-08-31

Expected to finish

2022-02-10

Last updated by the study team

2022-04-08

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, age 6 months or older
• Affirmation of participant's informed consent or legally authorized representative (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 also be willing to give written informed assent (if able) if the minor is within the age groups 7 to 11 years old and 12 to 17 years old.
• Confirmed CFI deficiency during the screening study, CFI-001, with a disease that is associated with an absence or deficiency in CFI
• Stated willingness of the participant to comply with all study procedures (including multiple blood draws) and availability for the duration of the study
• Stated willingness of the participant (or LAR) to allow access to his/her medical records with the purpose of assessing disease status and progression during his/her participation in the study

You may not qualify if…

• Participation in an interventional clinical study within the previous 30 days prior to screening or within ≤5 half-lives of the investigational drug, whichever is longer
• Having a major concurrent non-CFI-related disease that prevents the assessment of the natural course of the CFI deficiency disease
• Having a medical, psychosocial, or familial issues that might prevent full participation and cooperation with the procedures and requirements of the clinical study as determined by the potential participant/guardian and physician investigator

Where it is running

• Nephrology Consultants, LLC — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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