Safety and Tolerability Study of Pirfenidone in Combination With Nintedanib in Participants With Idiopathic Pulmonary Fibrosis (IPF)

PHASE4CompletedINTERVENTIONAL
Enrollment

89

Participants

Timeline

Start Date

January 14, 2016

Primary Completion Date

May 16, 2017

Study Completion Date

May 16, 2017

Conditions
Idiopathic Pulmonary Fibrosis
Interventions
DRUG

Nintedanib

Participants with IPF will receive nintedanib at the 200-300 mg/day dose up to 24 weeks.

DRUG

Pirfenidone

Participants with IPF will receive pirfenidone at 1602-2403 mg/day dose up to 24 weeks.

Trial Locations (38)

2900

Gentofte Hospital, Lungemedicinsk Afdeling, Hellerup

10029

Mount Sinai School of Medicine, New York

10032

Columbia University Medical Center, New York

10043

A.O. Universitaria San Luigi Gonzaga di Orbassano; Malattie Apparato Respiratorio (MAR2), Orbassano

20900

ASST DI MONZA; U O Clinica Pneumologica, Monza

22042

Inova Health Care Services; Advanced Lung Disease Transplant Program, Falls Church

24071

Complejo Asistencial Universitario de Leon; Pneumology, León

27403

Pulmonix LLC, Greensboro

28006

Hospital Universitario La Princesa; Servicio de Neumologia, Madrid

28822

Hospital del Henares; Medicina Interna. Unidad de Neumología, Coslada (Madrid)

29425

Medical University of South Carolina (MUSC); MUSC Pulmonary, Charleston

34239

Sarasota Memorial Hospital, Sarasota

35033

Hopital de Pontchaillou; Service de Pneumologie, Rennes

36043

Klinikum Fulda gAG; Universitätsmedizin Marburg, Campus Fulda, Fulda

37232

Vanderbilt University Medical Center, Nashville

38320

Hospital Universitario de Canarias; Servicio de Neumologia, San Cristóbal de La Laguna

41013

Hospital Universitario Virgen del Rocio; Servicio de Neumologia, Seville

45239

Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie, Essen

45267

UC Health Clinical Trials Office, Cincinnati

46014

Hospital General Universitario De Valencia; Servicio de Neumologia, Valencia

53100

A.O. Univ. Senese Policlinico S. Maria alle Scotte; UOC Malattie Resepiratorie e Trapianto Polmonare, Siena

56124

Azienda Ospedaliero Universitaria Pisana; U.O. Pneumologia, Pisa

63017

Cardio-Pulmonary Associates of St. Luke's Hospital, Chesterfield

68131

Creighton University, Omaha

69677

Hopital Louis Pradel; Pneumologie, Bron

93000

Hopital Avicenne; Pneumologie, Bobigny

94305

Stanford University School of Medicine ; Pulmonary/Critical Care Medicine, Stanford

97225

John A. Butler, M.D. - Oregon Pulmonary Associates, Portland

90095-1690

David Geffen School of Medicine at UCLA;Division of Pulmonary & Critical Care/ Department of Medic, Los Angeles

02215

Beth Israel Deaconess Medical Center, Boston

48109-0666

University of Michigan Health System, Ann Arbor

07901

Atlantic Respiratory Institute, Summit

T3M 1M4

South Health Campus/Alberta Health Services/ University of Calgary, Calgary

M5G 2N2

University Health Network, Toronto

01640

Fachkrankenhaus Coswig GmbH Zentrum f.Pneumologie Beatmungsmedizin Thorax-u.Gefäßchirurgie, Coswig

3435 CM

Antonius Ziekenhuis; Dept of Lung Diseases, Nieuwegein

3000 CA

Erasmus MC; Afdeling Longziekten, Rotterdam

08097

Hospital Universitari de Bellvitge ; Servicio de Neumologia, L'Hospitalet de Llobregat

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02598193 - Safety and Tolerability Study of Pirfenidone in Combination With Nintedanib in Participants With Idiopathic Pulmonary Fibrosis (IPF) | Biotech Hunter | Biotech Hunter