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

Recruiting in Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Forge Biologics, Inc

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

Inclusion Criteria

I have completed a clinical trial with FBX-101.

My guardian is ready and can follow the study's rules and visits.

Treatment Details

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Patients enrolled in the FBX-101-LTFU studyExperimental Treatment1 Intervention

The participants will be followed for 36 months after they have concluded their participation in the interventional trial. They will complete 5 scheduled visits with assessments as specified in the schedule of assessments, to collect data for safety and additional signs of efficacy for FBX-101. Those patients enrolled from any other early terminated trial, will first complete pending evaluations from that trial.