Efficacy and Safety of Sirolimus in LAM

PHASE3CompletedINTERVENTIONAL
Enrollment

89

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

September 30, 2010

Study Completion Date

February 28, 2011

Conditions
Lymphangioleiomyomatosis
Interventions
DRUG

Sirolimus

A sirolimus dose of 2 tablets (1 mg/tablet) per day for 1 year.

DRUG

Placebo

A placebo dose of 2 tablets per day for 1 year.

Trial Locations (13)

20892

National Heart, Lung, and Blood Institute, Bethesda

29425

Medical University of South Carolina, Charleston

32611

University of Florida, Gainesville, Gainesville

44195

Cleveland Clinic Foundation, Cleveland

45267

University of Cincinnati Medical Center, Cincinnati

75708

University of Texas Health Center at Tyler, Tyler

80206

National Jewish Medical and Research Center, Denver

90024

University of California Los Angeles, Los Angeles

97239

Oregon Health & Science University, Portland

02115

Harvard's Brigham and Women's Hospital, Boston

M5G 2N2

Toronto General Hospital, Toronto

591-8555

National Kinki-Chou Hospital, Sakai

Unknown

Niigata University Medical and Dental Hospital, Niigata

All Listed Sponsors
collaborator

Office of Rare Diseases (ORD)

NIH

collaborator

FDA Office of Orphan Products Development

FED

collaborator

National Center for Research Resources (NCRR)

NIH

lead

University of Cincinnati

OTHER

NCT00414648 - Efficacy and Safety of Sirolimus in LAM | Biotech Hunter | Biotech Hunter