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

Completed · Phase 4

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

This clinical study will evaluate the safety and tolerability of combination treatment of nintedanib and pirfenidone in participants with IPF. Eligible participants must have received pirfenidone for at least 16 weeks on a stable dose. Nintedanib will be added on Day 1 of the study as a combination treatment for IPF for 24 weeks.

Key facts

Study ID

NCT02598193

Run by

Hoffmann-La Roche

People needed

89

Starts

2016-01-14

Expected to finish

2017-05-16

Last updated by the study team

2018-06-13

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants who are on pirfenidone for at least 16 weeks and on a stable dose (defined as 1602-2403 mg/day) for at least 28 days at the start of Screening; the dose must be expected to remain in that range throughout the study
• Documented diagnosis of IPF, per the Investigator per using the criteria of the 2011 American Thoracic Society / European Respiratory Society / Japanese Respiratory Society / Latin American Thoracic Association guidelines
• Participants with percent predicted forced vital capacity (FVC) more than or equal to (>=) 50 percent (%) and percent predicted carbon monoxide diffusing capacity (DLco) >=30% at Screening
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one method with a failure rate of less than (<) 1% per year, during the treatment period and for at least 3 months after the final Follow-up Visit
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm during the treatment period and for at least 4 months after the final Follow-up Visit

You may not qualify if…

• Participants with clinical evidence of active infection
• Participant with any new or ongoing moderate or severe adverse reaction considered by the Investigator to be related to pirfenidone, or an pirfenidone treatment interruption in the 28 days before the start of Screening
• Any condition that is likely to result in death in the 12 months after the start of Screening
• Lung transplantation anticipated or any planned significant surgical intervention
• Known hypersensitivity to the active substance or any excipient of either pirfenidone or nintedanib
• Mild (Child Pugh A), moderate (Child Pugh B), or severe (Child Pugh C) hepatic and/or severe renal impairment
• History of gastrointestinal (GI) tract perforation, unstable or deteriorating cardiac or pulmonary disease (other than IPF), long QT syndrome, alcohol or substance abuse in the 2 years before the start of screening, use of any tobacco product in the 12 weeks before the start of screening
• Bleeding risk
• Use of Cytochrome P450 (CYP) 1A2 (CYP1A2) inhibitors (for example, fluvoxamine, enoxacin) and/or use of inhibitors of P-glycoprotein (for example, ketoconazole, erythromycin) or CYP3A4 (for example, ketoconazole, erythromycin) or their inducers (for example, rifampicin, carbamazepine, phenytoin, St John's wort) in the 28 days before the start of Screening
• Pregnancy or lactation
• Hypersensitivity to peanuts and/or soy
• Use of pirfenidone and/or nintedanib in a clinical study protocol in the 28 days before the start of screening

Where it is running

• David Geffen School of Medicine at UCLA;Division of Pulmonary & Critical Care/ Department of Medic — Los Angeles, California, United States
• Stanford University School of Medicine ; Pulmonary/Critical Care Medicine — Stanford, California, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Cardio-Pulmonary Associates of St. Luke's Hospital — Chesterfield, Missouri, United States
• Creighton University — Omaha, Nebraska, United States
• Atlantic Respiratory Institute — Summit, New Jersey, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Pulmonix LLC — Greensboro, North Carolina, United States
• UC Health Clinical Trials Office — Cincinnati, Ohio, United States
• John A. Butler, M.D. - Oregon Pulmonary Associates — Portland, Oregon, United States
• Medical University of South Carolina (MUSC); MUSC Pulmonary — Charleston, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Inova Health Care Services; Advanced Lung Disease Transplant Program — Falls Church, Virginia, United States
• South Health Campus/Alberta Health Services/ University of Calgary — Calgary, Alberta, Canada
• University Health Network — Toronto, Ontario, Canada
• Gentofte Hospital, Lungemedicinsk Afdeling — Hellerup, Denmark
• Hopital Avicenne; Pneumologie — Bobigny, France
• Hopital Louis Pradel; Pneumologie — Bron, France
• Hopital de Pontchaillou; Service de Pneumologie — Rennes, France
• Fachkrankenhaus Coswig GmbH Zentrum f.Pneumologie Beatmungsmedizin Thorax-u.Gefäßchirurgie — Coswig, Germany
• Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie — Essen, Germany
• Klinikum Fulda gAG; Universitätsmedizin Marburg, Campus Fulda — Fulda, Germany

Full record on ClinicalTrials.gov

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