CompletedPhase 2

A Second-generation AI Based Therapeutic Regimen in Patients With Gaucher Disease Treated With Enzyme Replacement Therapy.

Israel5 participantsStarted 2022-04-01

Plain-language summary

An open-labeled, prospective, single-center proof-of-concept study. Patients with Gaucher Disease aged 18-75 who received intravenous Enzyme Replacement Therapy once every two weeks were enrolled. The study utilized the Altus Care™ cellular phone-based application, which integrated an algorithm-based approach to provide random dosing regimens within a pre-defined range determined by the physician. The app allowed personalized therapeutic regimens with variations in dosages and administration times.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult \>18 years old * Non-pregnant * Diagnosed with Gaucher disease * Treated with ERT for a minimum of 3 years * An unchanged dose in the past 6/12 months Exclusion Criteria: * Pregnant * Patients with evidence of severe infectious, malignant, autoimmune, or other disabling systemic diseases * Patients unable to provide written informed consent * Patients that do not possess a smartphone * Patients who cant adhere to the visit schedule and protocol.

What they're measuring

Platelet

Timeframe: 6 month

Hemoglobin

Timeframe: 6 month

Lyso GB1

Timeframe: 6 month

SF-36

Timeframe: 6 month

Trial details

NCT IDNCT06050967

SponsorHadassah Medical Organization

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-01

View on ClinicalTrials.gov More Gaucher Disease Type 1 trials