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Clinical Trials/NCT02598193
NCT02598193
Completed
Phase 4

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

Hoffmann-La Roche38 sites in 8 countries89 target enrollmentStarted: January 14, 2016Last updated:
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ConditionsIdiopathic Pulmonary Fibrosis
InterventionsNintedanibPirfenidone
DrugsNintedanibPirfenidone

Overview

Phase
Phase 4
Status
Completed
Enrollment
89
Locations
38
Primary Endpoint
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/Day
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Pirfenidone+Nintedanib

Experimental

Participants 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.

Intervention: Nintedanib (Drug)

Pirfenidone+Nintedanib

Experimental

Participants 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.

Intervention: Pirfenidone (Drug)

Outcomes

Primary Outcomes

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/Day

Time Frame: Week 24

Secondary Outcomes

  • Total Number of Days From the Initiation of Combination Treatment to Discontinuation of Pirfenidone, Nintedanib, or Both Study Treatments(Baseline up to Week 24)
  • Percentage of Participants With Adverse Events and Serious Adverse Events(Baseline up to Week 28)
  • Total Number of Participant Days of Combination Treatment With Pirfenidone and Nintedanib(Baseline up to Week 24)
  • Percentage of Participants Who Discontinue Pirfenidone, Nintedanib, or Both Study Treatments Because of Adverse Events Before the Week 24 Visit(Baseline up to Week 24)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (38)

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