Cerliponase Alfa Observational Study in the US

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Trial Status Active Not Recruiting

Trial Identifier

NCT04476862

Condition

CLN2, Late-Infantile Neuronal Ceroid Lipofuscinosis Type 2

The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. and has not been edited.

Trial Summary

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.

Eligibility Criteria

Birth Sex

All

Age

Any

Healthy Volunteers

No

Drug/Treatment:

Cerliponase Alfa, Administration Kit

Study Type:

Observational

Number of Participants:

35

Study Started:

2020-08-19

Study Updated:

2024-09-19

Trial Locations

  • Arkansas Children's Hospital

    Little Rock, Arkansas, United States

  • Children's Hospital of Orange County

    Orange, California, United States

  • Children's Hospital of Colorado

    Aurora, Colorado, United States

  • Children's National Hospital

    Washington, District of Columbia, United States

  • Advent Health

    OrLando, Florida, United States

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, United States

  • Rush University Medical Center

    Chicago, Illinois, United States

  • Boston Children's Hospital,

    Boston, Massachusetts, United States

  • Children's Hospital Minnesota

    Minneapolis, Minnesota, United States

  • NYU Langone Medical Center

    New York, New York, United States

  • Mt. Sinai School of Medicine

    New York, New York, United States

  • University of Rochester Medical Center

    Rochester, New York, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, United States

  • Texas Children's Hospital

    Houston, Texas, United States

  • Seattle Children's Hospital

    Seattle, Washington, United States

Inclusion Criteria

1. Diagnosed with CLN2 disease.
2. Currently receiving or plan to begin treatment with cerliponase alfa.
3. Written informed consent/assent obtained.

Exclusion Criteria

1. Currently receiving treatment in another investigational device or drug study

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