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Long-Term Follow-Up for HMI-102 in Phenylketonuria (PKU)

This study is a long-term follow-up for people who have previously received HMI-102. HMI-102 is a genetic intervention designed to help with Phenylketonuria (PKU) and PAH Deficiency. The main goal is to check for any special or serious side effects related to HMI-102 over five years. To join, you must be between 18 and 55 years old and have already received HMI-102. You also need to understand the study and be willing to follow its procedures. The study is currently unclear on its recruitment status, but it plans to enroll 21 participants.

Study design
This is an open-label, observational study, meaning both you and the study staff will know you are receiving HMI-102. It plans to include 21 participants.
What's involved
You will need to comply with all study procedures and long-term follow-up requirements. The study will evaluate your safety from the start up to five years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for five years to monitor for adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04348708

Long-Term Follow Up Study of Subjects Previously Administered HMI 102

Enrolling by Invitation
Not specifiedAges 18–55Observational
Homology Medicines, Inc
~21 participants
Updated 2022-06-30 on ClinicalTrials.gov
What's tested:HMI-102

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of adverse events of special interest (AESIs) and serious adverse events (SAEs) related to HMI 102
Measured over Baseline to year 5

Conditions

Phenylketonuria
PAH Deficiency

Explore related trials

Classical PhenylketonuriaPhenylketonuria

Where it's being run

2 sites across 2 states
Massachusetts1
New York1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Subject was previously administered HMI 102.
Subject is able to understand the purpose and risks of the study and is willing to provide informed consent.
Subject is able to comply with all study procedures and long-term follow-up.

Exclusion

Participation in the study is not in the subject's best interest, in the opinion of the Investigator.

What this trial measures

  • Incidence and severity of adverse events of special interest (AESIs) and serious adverse events (SAEs) related to HMI 102Baseline to year 5

    Subjects with at least one AESI or SAE