Status and phase
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Treatments
About
MYALEPT™ (metreleptin) has been approved as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (MYALEPT Prescribing Information). This study is a multicenter, open-label, Phase 4 trial to provide an assessment of the immunogenicity associated with metreleptin and of any major potential risks due to development of antibodies to metreleptin. The study is being conducted to comply with a postmarketing requirement.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Involvement in the planning and/or conduct of the study (applies to both Aegerion staff and/or staff at the study site.)
Previous treatment with metreleptin.
Participation in another clinical study with an investigational product during the last 6 months.
Patients with prior severe hypersensitivity reactions to metreleptin or to any of the product components.
Known to have tested positive for human immunodeficiency virus, are immunocompromised, or are receiving immunomodulatory drugs.
Known history of drug or alcohol abuse within 1 year of screening.
Creatinine clearance <30 mL/min using institutional standards:
e.g., calculated using Cockcroft-Gault formula for patients ≥18 years of age; calculated using Schwartz equation for patients <18 years of age.
For women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
Any condition where, in the opinion of the Investigator, participation in this study may pose a significant risk to the patient or could render the patient unable to successfully complete the study.
Primary purpose
Allocation
Interventional model
Masking
10 participants in 1 patient group
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Central trial contact
Janet Boylan
Data sourced from clinicaltrials.gov
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