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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 6 January 2025
Main ID:  NCT05506254
Date of registration: 16/08/2022
Prospective Registration: No
Primary sponsor: LogicBio Therapeutics, Inc
Public title: Long-term Follow-up Study of Patients Who Received hLB-001 Gene Therapy
Scientific title: A Long-term Follow-up Study of Patients in LogicBio Clinical Trials for Methylmalonic Acidemia Characterized by MMUT Mutations Who Received hLB-001
Date of first enrolment: July 20, 2022
Target sample size: 4
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/ct2/show/NCT05506254
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
United States
Contacts
Key inclusion & exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

- None



Age minimum: N/A
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Methylmalonic Acidemia
Intervention(s)
Drug: hLB-001
Primary Outcome(s)
Incidence of treatment emergent adverse events [Time Frame: 15 years]
Secondary Outcome(s)
Secondary ID(s)
LB-001LT
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Alexion Pharmaceuticals, Inc.
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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