TerminatedNot Applicable

Long-term Follow-up Study to Evaluate Safety and Efficacy of FBX-101 in Krabbe Patients

Stopped: The FBX-101 clinical program has been discontinued by Forge Biologics

United States2 participantsStarted 2024-08-06

Plain-language summary

This is an observational study that will enroll any patients with Krabbe disease that have participated in prior interventional clinical trials involving the administration of FBX-101.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants that have completed a prior clinical trial involving the administration of FBX-101. * Parent(s)/legal guardian(s) of participant willing and able to complete the informed consent process and comply with study procedures and visit schedule. Exclusion Criteria: •Planned or current participation in any other interventional clinical study that may confound the safety or efficacy evaluation of FBX-101 during this study.

What they're measuring

Long Term safety as assessed by incidence of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) that are attributed to FBX-101

Timeframe: 36 months

Trial details

NCT IDNCT06308718

SponsorForge Biologics, Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-04-10

View on ClinicalTrials.gov More Krabbe Disease trials