MEASuRE: Metreleptin Effectiveness And Safety Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorChiesi Farmaceutici S.p.A.
About this trial
The study is a post-authorization, prospective, voluntary registry of patients treated with commercial metreleptin including, but not limited to, patients in the US and EEA.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients treated with metreleptin through commercial supply at the time or before enrolment into registry
Patients who provide a written consent
Patient coming off metreleptin clinical studies and continuing or restarting treatment with metreleptin through commercial supply
Disqualifiers
None
Trial population
Patients in the US with Generalised Lipodystrophy treated with commercial Metreleptin, and patients in the EEA with either Generalised Lipodystrophy or Partial Lipodystrophy, treated with commercial Metreleptin
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Metreleptin
Drug
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Metreleptin1 intervention
Trial outcomes
Primary outcomes
1
The severity and incidence of the following safety events in patients prescribed Metreleptin in routine clinical practice
Estimation of the incidence rates of the following events of special interest in patients treated with metreleptin as part of current clinical practice: acute pancreatitis associated with discontinuation of metreleptin including fatal or necrotizing pancreatitis, hepatic adverse events, severe hypoglycemia, serious hypersensitivity reactions, serious and severe infections resulting in hospitalization or death, loss of efficacy, new diagnoses of autoimmune disorders, autoimmune disease exacerbation, all cancers, exposed pregnancies and pregnancy outcomes, all-cause deaths, medication errors.
Time frame
Adverse events will be collected from first dose to last visit - min. 10 years. For Prevalent Users: Serious adverse events will be collected from 6 months prior to enrolment to last visit - min. 10 years.Secondary outcomes
1
Characteristics of the study population in terms of demographic profile, vital signs and clinical signs
Description of the overall demographic and clinical characteristics in all patients treated with metreleptin (pattern of use analysis)
Time frame
Demographics and Vital Signs information will be collected at all study visits - min. 10 years2
Characteristics of the study population in terms of clinical chemistry - Glycated Hemoglobin (HbA1c), Fasting Plasma Glucose (FPG) and Triglycerides (TG)
Description of routine laboratory measurements that could be inferred as efficacy endpoints (including HbA1c, FPG, and TG) over time
Time frame
Clinical chemistry will be collected at all study visits - min. 10 years3
Characteristics of the study population in terms of its use of metreleptin
Description of the metreleptin exposure information in all patients treated with metreleptin (pattern of use analysis)
Time frame
Treatment information will be collected at all study visits - min. 10 yearsSponsors and contacts
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Source ClinicalTrials.gov