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Cerliponase Alfa Observational Study in the US

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. 4 versions Re-verified since Sep 10, 2024, no change to tracked fieldsv6-v9
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Aug 24, 2030 to Aug 31, 2030
    • Site details revised at 16 of 16 sites
    v5
  3. Study sites: 14 to 16v4
  4. Study sites: 7 to 14v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 7
    • Start date changed from estimate of Aug 24, 2020 to Aug 19, 2020
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a multicenter, observational study for patients with a confirmed diagnosis of neuronal ceroid lipofuscinosis type 2 (CLN2 disease), also known as TPP1 deficiency, who intend to be or are currently being treated with cerliponase alfa. Patients receiving or expected to receive cerliponase alfa within 60 days of signing the informed consent form (ICF) may be eligible to enroll in the study, assuming all regulatory requirements for sites that have agreed to participate and protocol inclusion criteria are met. Data may be collected for all or some of the assessments as outlined in the protocol, dependent upon the clinic's and/or individual patient's standard of care.
Trial Details
NCT Number NCT04476862
Lead Sponsor BioMarin Pharmaceutical
Conditions
(from sponsor)		 Late-Infantile Neuronal Ceroid Lipofuscinosis Type 2
Related terms Neuronal Ceroid-Lipofuscinoses
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov