CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 32 enrolled
Drug / intervention
elapegademase-lvlrbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03878069
NCT03878069N/ACompleted
CompareCT.gov

Single Arm, Open-Label, Multicenter, Registry Study of Revcovi (Elapegademase-lvlr) Treatment in ADA-SCID Patients Requiring Enzyme Replacement Therapy

Chiesi Farmaceutici S.p.A.·observational·Posted Mar 18, 2019·Updated Nov 15, 2024

In Brief

An observational study evaluating elapegademase-lvlr for Adenosine Deaminase Severe Combined Immunodeficiency. Completed, enrolled 32 participants across 14 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAdenosine Deaminase Severe Combined Immunodeficiency
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 18, 2019
Enrollment StartSep 30, 2019
Primary CompletionJan 18, 2023
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 7.3 years ago

Interventions

elapegademase-lvlrbiological

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.