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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.

Register:	ClinicalTrials.gov
Last refreshed on:	4 March 2024
Main ID:	NCT02262832
Date of registration:	10/10/2014
Prospective Registration:	No
Primary sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Public title:	Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy
Scientific title:	Compassionate Use of Metreleptin in Previously-Treated Patients With Generalized Lipodystrophy
Date of first enrolment:	October 9, 2014
Target sample size:	30
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/ct2/show/NCT02262832
Study type:	Interventional
Study design:	Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 3

Countries of recruitment
United States

Contacts

Name:	Megan S Startzell, R.N.
Address:
Telephone:	(301) 402-6371
Email:	megan.startzell@nih.gov
Affiliation:

Name:	Rebecca J Brown, M.D.
Address:
Telephone:
Email:
Affiliation:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Name:	For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
Address:
Telephone:	800-411-1222
Email:	ccopr@nih.gov
Affiliation:

Key inclusion & exclusion criteria

- INCLUSION CRITERIA:

1. Age greater than or equal to 6 months.

2. Generalized lipodystrophy (either congenital or acquired).

3. Those who cannot obtain metreleptin through approved or compassionate use
mechanisms in their home country.

EXCLUSION CRITERIA:

1. Availability of metreleptin to the patient either as an approved drug, or through
local compassionate use or expanded access programs.

2. Known HIV infection or HIV-associated lipodystrophy.

3. Any medical condition or medication that will increase risk to the subject.

4. Current alcohol or substance abuse.

5. Subjects who have a known hypersensitivity to E. coli derived proteins (as leptin is
derived from such proteins).

Age minimum: 6 Months
Age maximum: 98 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lipodystrophy

Hyperlipidemia

Diabetes

Intervention(s)

Drug: Metreleptin

Primary Outcome(s)

Serum hemoglobin A1C [Time Frame: every 6-12 months]

Serum triglycerides [Time Frame: every 6-12 months]

Secondary Outcome(s)

Pituitary & Reproductive Function [Time Frame: every 6-12 months]

Ectopic lipid & body composition [Time Frame: every 12 months]

Steatohepatosis [Time Frame: every 12 months]

Bone mineral density & metabolism [Time Frame: every 12 months]

Secondary ID(s)

15-DK-0003

150003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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