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

Phase 4
Completed
Conditions
Idiopathic Pulmonary Fibrosis
Interventions
Registration Number
NCT02598193
Lead Sponsor
Hoffmann-La Roche
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
89
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Pirfenidone+NintedanibNintedanibParticipants with IPF will receive pirfenidone at 1602-2403 milligrams per day (mg/day) dose and nintedanib at the 200-300 mg/day dose up to 24 weeks.
Pirfenidone+NintedanibPirfenidoneParticipants with IPF will receive pirfenidone at 1602-2403 milligrams per day (mg/day) dose and nintedanib at the 200-300 mg/day dose up to 24 weeks.
Primary Outcome Measures
NameTimeMethod
Percentage of Participants Who Complete 24 Weeks of Combination Treatment on Pirfenidone at a Dose of 1602-2403 mg/Day and Nintedanib at a Dose of 200-300 mg/DayWeek 24
Secondary Outcome Measures
NameTimeMethod
Percentage of Participants With Adverse Events and Serious Adverse EventsBaseline up to Week 28

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

Total Number of Participant Days of Combination Treatment With Pirfenidone and NintedanibBaseline up to Week 24
Percentage of Participants Who Discontinue Pirfenidone, Nintedanib, or Both Study Treatments Because of Adverse Events Before the Week 24 VisitBaseline up to Week 24
Total Number of Days From the Initiation of Combination Treatment to Discontinuation of Pirfenidone, Nintedanib, or Both Study TreatmentsBaseline up to Week 24

Trial Locations

Locations (38)

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

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David Geffen School of Medicine at UCLA;Division of Pulmonary & Critical Care/ Department of Medic
🇺🇸Los Angeles, California, United States

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