Natural History Study: ENPP1 Deficiency or the Early-Onset Form of ABCC6 Deficiency

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Trial Status Completed

Trial Identifier

NCT07745179

Condition

ATP-Binding Cassette Subfamily C Member 6 Deficiency, Ectonucleotide Pyrophosphatase/Phosphodiesterase1 Deficiency, Autosomal Recessive Hypophosphatemic Rickets, Generalized Arterial Calcification of Infancy, PXE (Pseudoxanthoma Elasticum)

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

The purpose of this study is to characterize the natural history of ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) Deficiency and the early-onset form of adenosine triphosphate binding cassette transporter subfamily C member 6 (ABCC6) Deficiency through retrospective review of medical records and other available data sources. Information collected on medical history, clinical manifestations, radiographic imaging, and other disease-related assessments may be used to support the development of future therapies for these diseases.

Eligibility Criteria

Birth Sex

All

Age

From 1 Day

Healthy Volunteers

No

Study Type:

Observational

Number of Participants:

23

Study Started:

2018-12-05

Study Updated:

2026-08-04

Trial Locations

  • Children's Hospital of Philadelpha

    Philadelphia, Pennsylvania, United States

  • Centre de References des Maladies Neuromusculaires (CRMN)

    La Tronche, France

  • Hospices Civils de Lyon

    Lyon, France

  • Hopital Necker-Enfants Malades

    Paris, France

  • University Hospital Munster

    Münster, Germany

  • Birmingham Children's Hospital

    Birmingham, United Kingdom

  • Evelina London Children's Hospital

    London, United Kingdom

  • Royal Manchester University Hospital

    Manchester, United Kingdom

Inclusion Criteria

Inclusion Criteria

Participants were eligible for inclusion if they met at least one of the following criteria:

1. Generalized arterial calcification of infancy (GACI) genotype, defined as two pathogenic mutations in ENPP1 and/or ABCC6, confirmed by mutational analysis, and a GACI phenotype confirmed by imaging or biopsy.
2. GACI phenotype confirmed by imaging or biopsy, with mutational analysis demonstrating that each parent carried at least one mutation in ENPP1 and/or ABCC6.
3. Biallelic mutations in ENPP1 and a clinical phenotype consistent with ENPP1 Deficiency.
4. Mutational analysis demonstrating that each parent carried at least one mutation in ENPP1, together with clinical signs and symptoms consistent with ENPP1 Deficiency in the participant.
5. Availability of medical records and source documentation sufficient for retrospective review.

Exclusion Criteria

Exclusion Criteria

1. Insufficient medical records, imaging studies, or source documentation to support retrospective data collection.
2. Diagnosis not consistent with ENPP1 Deficiency, GACI, or early-onset ABCC6 Deficiency.
3. Inability to obtain informed consent from the participant or legally authorized representative, as required by local regulations.

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