FLT201 for Gaucher Disease

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Freeline Therapeutics

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This is a multicenter, long-term, follow-up trial of participants with Gaucher disease type 1 who received FLT201 treatment in a preceding clinical trial. Participants will be followed for 5 years post-treatment.

Do I need to stop my current medications for the FLT201 trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Eligibility Criteria

This trial is for individuals with Type-1 Gaucher Disease who have previously received FLT201 treatment in an earlier study. They will be monitored over a period of 5 years to understand the long-term effects of the treatment.

Inclusion Criteria

Participants able to give full informed consent and able to comply with all requirements of the trial

I have previously been treated with FLT201, even if I had to start or restart enzyme replacement therapy.

Exclusion Criteria

N/A

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants received FLT201 treatment in a preceding clinical trial

Not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Regular visits over 5 years

Treatment Details

Interventions

FLT201 (Virus Therapy)

Trial OverviewThe trial is observing the long-term outcomes and safety of FLT201, a therapy for Type-1 Gaucher Disease, by following participants from a previous clinical study over five years after their last dose.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Dosed with FLT201Experimental Treatment1 Intervention