Screening Study to Identify Patients With Complement Factor I Deficiencies

March 31, 2022 updated by: Catalyst Biosciences
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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

113

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • Nephrology Consultants, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients previously diagnosed with a complement-mediated disease and/or with clinical manifestations in which a reasonable etiological association with Complement Factor I (CFI) deficiency has been reported.

Examples of these diseases and conditions are (but not limited to): atypical hemolytic uremic syndrome, Complement 3 Glomerulopathy, membranoproliferative glomerulonephritis, systemic lupus erythematosus, leukocytoclastic vasculitis, recurrent bacterial infections, unexplained inflammation or edema, and some autoimmune disorders.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complement Factor I Deficiency Identification
Time Frame: At Screening
Identification of participants with a CFI deficiency and percentage of those with a CFI deficiency versus total number of screened participants
At Screening

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographics, Disease Characteristics, Medication Use
Time Frame: At Screening
Demographics, disease characteristics (including disease history), and disease-related medication use. Complement levels and mutation data will also be collected from medical records, if previously assessed and available.
At Screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalyst Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 21, 2021

Primary Completion (ACTUAL)

November 23, 2021

Study Completion (ACTUAL)

November 23, 2021

Study Registration Dates

First Submitted

September 29, 2021

First Submitted That Met QC Criteria

September 29, 2021

First Posted (ACTUAL)

October 11, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2022

Last Update Submitted That Met QC Criteria

March 31, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFI-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe