Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)

PHASE2CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

Conditions
Systemic Sclerosis
Interventions
DRUG

Pirfenidone

Pirfenidone will be administered orally at a dose of 267 mg one oral capsule TID (801 mg/day) for 1 or 2 weeks followed by two 267 mg oral capsules TID (1602 mg/day) for 1 or 2 weeks (titration period) and then three 267 mg oral capsules TID (2403 mg/day) for 12 weeks (maintenance period).

Trial Locations (22)

10021

Hospital for Special Surgery, New York

10032

Columbia University, New York

10043

Università di Torino, Orbassano

15261

University of Pittsburgh Medical Center, Pittsburgh

20007

Georgetown University Hospital, Washington D.C.

29425

Medical University South Carolina, Charleston

43614

University of Toledo, Toledo

44195

Cleveland Clinic Foundation, Cleveland

45267

University of Cincinnati, Cincinnati

48109

University of Michigan, Ann Arbor

50139

University of Florence, Florence

60611

Northwestern University, Chicago, Chicago

77030

University of Texas, Houston, Houston

80206

National Jewish Medical and Research Center, Denver

84132

University of Utah, Salt Lake City

85259

Mayo Clinic, Scottsdale, Scottsdale

90095

University of California, Los Angeles, Los Angeles

94063

Stanford University School of Medicine, Redwood City

94143

University of California, San Francisco, San Francisco

02118

Boston University Medical Center, Boston

L8N 142

St. Joseph's Healthcare, Hamilton

M5T 3L9

Toronto General Hospital, Toronto

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY

NCT01933334 - Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS) | Biotech Hunter | Biotech Hunter