TerminatedNot Applicable

A Long-term Follow-up Study of Patients With MPS IIIB Treated With ABO-101

Stopped: Abeona has decided to discontinue development activities for Product AB0-101 due to a lack of drug supply and for business reasons unrelated to the product safety profile and/or signs of efficacy

United States, France, Germany1 participantsStarted 2020-10-28

Plain-language summary

This is a multicenter, non-interventional, long-term follow-up (LTFU) study in participants who have been treated with ABO-101 in a prior trial. Eligible participants will undergo clinical evaluations at prespecified intervals for 3 years from the last visit in the prior clinical trial (up to 5 years post-treatment).

Who can participate

SexALL

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Inclusion Criteria: * Participants that have completed a prior clinical trial involving the administration of ABO-101 * Parent(s)/legal guardian(s) of participant willing and able to complete the informed consent process and comply with study procedures and visit schedule Exclusion Criteria: * Planned or current participation in another clinical trial that may confound the safety and efficacy evaluation of ABO-101 during the duration of this study * Any other situation that precludes the participant from undergoing procedures required in this study

What they're measuring

Adverse Events

Timeframe: 60 months

Trial details

NCT IDNCT04655911

SponsorAbeona Therapeutics, Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-04-07

View on ClinicalTrials.gov More Mucopolysaccharidosis III-B trials