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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 March 2024 |
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Main ID: |
NCT04026178 |
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Date of registration:
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30/10/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Immunogenicity of Metreleptin in Patients With Generalized Lipodystrophy
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Scientific title:
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A 36-Month, Multicenter, Open Label Phase 4 Study to Evaluate the Immunogenicity of Daily SC Metreleptin Treatment in Patients With Generalized Lipodystrophy |
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Date of first enrolment:
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November 14, 2018 |
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Target sample size:
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10 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT04026178 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Janet Boylan |
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Address:
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Telephone:
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Email:
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Affiliation:
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Aegerion Pharmaceuticals, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Provision of informed consent prior to any study specific procedures. If <18 years of
age, has a parent or guardian able to read, understand, and sign the Informed Consent
Form (ICF) and a Child Assent form, communicate with the Investigator, and understand
and comply with protocol requirements. Adolescent patients must also read and
understand the Child Assent Form. If the child is too young or unable to read, then
the Child Assent form must be explained to the child.
2. Female and/or male patients =1 years of age.
3. Physician-confirmed diagnosis of congenital or acquired generalized lipodystrophy and
will begin treatment with MYALEPT for the first time.
4. Negative pregnancy test (urine or serum) for female patients of childbearing
potential.
5. Female patients of childbearing potential must be 1 year postmenopausal, surgically
sterile, or be willing to use an acceptable method of contraception (an acceptable
method of contraception is defined as a barrier method in conjunction with a
spermicide) for the duration of the study (from the time they sign consent). In
addition, oral contraceptives, approved contraceptive implant, long-term injectable
contraception, intrauterine device, or tubal ligation are allowed. Oral contraception
alone is not acceptable; additional barrier methods in conjunction with spermicide
must be used.
6. Male patients must be surgically sterile or be willing to use an acceptable method of
contraception (defined as barrier methods in conjunction with spermicides) for the
duration of the study (from the time they sign consent).
7. Patients who are blood donors should not donate blood during the study and for 3
months following their last dose of metreleptin.
Exclusion Criteria:
1. Involvement in the planning and/or conduct of the study (applies to both Aegerion
staff and/or staff at the study site.)
2. Previous treatment with metreleptin.
3. Participation in another clinical study with an investigational product during the
last 6 months.
4. Patients with prior severe hypersensitivity reactions to metreleptin or to any of the
product components.
5. Known to have tested positive for human immunodeficiency virus, are immunocompromised,
or are receiving immunomodulatory drugs.
6. Known history of drug or alcohol abuse within 1 year of screening.
7. 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.
8. For women only - currently pregnant (confirmed with positive pregnancy test) or
breast-feeding.
9. 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.
Age minimum:
1 Year
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Generalized Lipodystrophy
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Intervention(s)
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Drug: Metreleptin
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Primary Outcome(s)
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Percentage of participants who develop anti-metreleptin/leptin antibodies at any timepoint after treatment with metreleptin
[Time Frame: Month 36]
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Percentage of participants who develop anti-metreleptin/leptin antibodies with neutralizing activity at any timepoint after treatment with metreleptin
[Time Frame: Month 36]
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Secondary Outcome(s)
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Percentage of participants with neutralizing or non-neutralizing antibodies who also show one or several of: a. Significant change of HbA1c b. Significant change of triglycerides c. Concomitant SAEs, AESIs or AEs leading to discontinuation
[Time Frame: Baseline and Months 1, 2, 4, 6, 9, 12, 18, 24, 30, 36]
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Percentage of participants with SAEs, AESIs or adverse events leading to discontinuation
[Time Frame: Baseline and Months 1, 2, 4, 6, 9, 12, 18, 24, 30, 36]
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Secondary ID(s)
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AEGR-734-401
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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