NCT05506254

Brief Summary

This is a non-interventional long-term follow-up study of patients who have participated in LogicBio studies for the treatment of MMA and received hLB-001

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
130mo left

Started Jul 2022

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Jul 2022Jan 2037

Study Start

First participant enrolled

July 15, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 16, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
14.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2037

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2037

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

14.5 years

First QC Date

August 16, 2022

Last Update Submit

February 3, 2026

Conditions

Methylmalonic Acidemia

Outcome Measures

Primary Outcomes (1)

  • Incidence of treatment emergent adverse events

    15 years

Study Arms (1)

Patients who have previously received hLB-001

Drug: hLB-001

Interventions

hLB-001DRUG

hLB-001 gene therapy

Patients who have previously received hLB-001

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a non-interventional long-term follow-up study of participants who have participated in LogicBio studies for the treatment of MMA and received hLB-001.

You may qualify if:

  • Participant has previously participated in a LogicBio clinical trial and received hLB-001.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Clinical Trial Site

Atlanta, Georgia, 30322, United States

Location

Clinical Trial Site

Pittsburgh, Pennsylvania, 15224, United States

Location

Clinical Trial Site

Nashville, Tennessee, 37232, United States

Location

Clinical Trial Site

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Methylmalonic acidemia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 18, 2022

Study Start

July 15, 2022

Primary Completion (Estimated)

January 1, 2037

Study Completion (Estimated)

January 1, 2037

Last Updated

February 5, 2026

Record last verified: 2026-02

Locations

US(4)