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Registry Study of Revcovi Treatment in Patients With ADA-SCID

NCT03878069 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2024-11-15

Study results available
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Summary

This registry study is being conducted in patients with adenosine deaminase severe combined immune deficiency (ADA-SCID) who require enzyme replacement therapy (ERT) treatment with Revcovi. Data on safety and on measures of efficacy are collected.

Conditions

  • Adenosine Deaminase Severe Combined Immunodeficiency

Interventions

BIOLOGICAL

elapegademase-lvlr

Revcovi is administered intramuscularly (i.m.). Weekly dosage is calculated in mg/kg of body weight, and can be adjusted over the course of the trial based on ADA activity and dAXP concentration as well as on clinical assessment by the treating physician.

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Eligibility

Min Age
0 Months
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2023-01-18
Completion
2023-01-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03878069 on ClinicalTrials.gov