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



Status:Completed
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - 80
Updated:6/15/2018
Start Date:January 14, 2016
End Date:May 16, 2017

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An Exploratory Multicenter, Open-Label, Single Arm Study of the Safety and Tolerability of Pirfenidone (Esbriet®) in Combination With Nintedanib (Ofev®) in Patients With Idiopathic Pulmonary Fibrosis

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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
17
sites
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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4448 Front Street Southeast
Calgary, Alberta t3m 1m4
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171 Ashley Avenue
Charleston, South Carolina 29425
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222 S Woods Mill Rd # 310N
Chesterfield, Missouri 63017
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Cincinnati, Ohio 45206
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8110 Gatehouse Road
Falls Church, Virginia 22042
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Greensboro, North Carolina 27403
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New York, New York 10029
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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2500 California Plaza
Omaha, Nebraska 68102
(402) 280-2700
Creighton University Creighton University, located in Omaha, Neb., offers a top-ranked education in the Jesuit...
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9155 Southwest Barnes Road
Portland, Oregon 97225
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Portland, OR
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1700 S Tamiami Trail
Sarasota, Florida 34239
(941) 917-9000
Sarasota Memorial Hospital Sarasota Memorial Health Care System, an 806-bed regional medical center, is among...
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99 Beauvoir Avenue
Summit, New Jersey 07901
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Summit, NJ
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