A Phase 4, Observational, Multicenter, 10-year Prospective Cohort Safety Study Comparing Subjects With HIV-associated Abdominal Lipohypertrophy Exposed to EGRIFTA® (Tesamorelin for Injection) to a Similar Group of Subjects Not Exposed to EGRIFTA®
Observational
Observational Model: Cohort, Time Perspective: Prospective
Time to development of malignancies in HIV-infected subjects with abdominal lipohypertrophy exposed to EGRIFTA® vs. concurrent, comparable control group not exposed to EGRIFTA®
10 years
Yes
Alexandra Mangili, MD, MPH
Study Director
EMD Serono, Inc.
United States: Food and Drug Administration
EMR200147-501
NCT01579695
February 2013
January 2025
Name | Location |
---|---|
Call EMD Serono Medical Information for information on recruiting sites | Rockland, Massachusetts 02370 |
Call EMD Serono Medical Information for Recruiting Sites | Rockland, Massachusetts 02370 |