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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02598193
First received: November 4, 2015
Last updated: April 11, 2017
Last verified: April 2017
  Purpose
This clinical study will evaluate the safety and tolerability of combination treatment of nintedanib and pirfenidone in participants with IPF. Eligible participant 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.

Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Drug: Nintedanib
Drug: Pirfenidone
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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: Up to Week 24 ]

Secondary Outcome Measures:
  • Percentage of Participants with Adverse Events and Serious Adverse Events [ Time Frame: Up to Week 24 ]
  • Percentage of Participants Who Discontinue Pirfenidone, Nintedanib, or Both Study Treatments Because of Adverse Events Before the Week 24 Visit [ Time Frame: Up to Week 24 ]
  • Total Number of Participants Days of Combination Treatment With Pirfenidone and Nintedanib [ Time Frame: Up to Week 24 ]
  • Total Number of Days From the Initiation of Combination Treatment to Discontinuation of Pirfenidone, Nintedanib, or Both Study Treatments [ Time Frame: Up to Week 24 ]

Enrollment: 89
Actual Study Start Date: January 14, 2016
Estimated Study Completion Date: May 31, 2017
Estimated Primary Completion Date: May 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pirfenidone+Nintedanib
Participants with IPF will receive pirfenidone at 1602-2403 mg/day dose and nintedanib at the 300 mg/day dose up to 24 weeks.
Drug: Nintedanib
Participants with IPF will receive nintedanib at the 300 mg/day dose up to 24 weeks.
Other Name: Ofev
Drug: Pirfenidone
Participants with IPF will receive pirfenidone at 1602-2403 mg/day dose up to 24 weeks.
Other Name: Esbriet

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants who are on pirfenidone for at least 16 weeks and on a stable dose (defined as 1602-2403 milligrams per day [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% 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.

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.
  • Severe hepatic and/or 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, use of any tobacco product etc.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02598193

  Show 38 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02598193     History of Changes
Other Study ID Numbers: MA29895
2015-003280-11 ( EudraCT Number )
Study First Received: November 4, 2015
Last Updated: April 11, 2017

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Pirfenidone
Nintedanib
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 28, 2017