Safety and Tolerability Study of Pirfenidone in Combination With Nintedanib in Participants With Idiopathic Pulmonary Fibrosis (IPF)
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ClinicalTrials.gov Identifier: NCT02598193 |
Recruitment Status :
Completed
First Posted : November 5, 2015
Results First Posted : June 13, 2018
Last Update Posted : June 13, 2018
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Condition or disease | Intervention/treatment | Phase |
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Idiopathic Pulmonary Fibrosis | Drug: Nintedanib Drug: Pirfenidone | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 89 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
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 |
Actual Study Start Date : | January 14, 2016 |
Actual Primary Completion Date : | May 16, 2017 |
Actual Study Completion Date : | May 16, 2017 |

Arm | Intervention/treatment |
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Experimental: Pirfenidone+Nintedanib
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.
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Drug: Nintedanib
Participants with IPF will receive nintedanib at the 200-300 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 |
- 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 ]
- Percentage of Participants With Adverse Events and Serious Adverse Events [ Time Frame: Baseline 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.
- Percentage of Participants Who Discontinue Pirfenidone, Nintedanib, or Both Study Treatments Because of Adverse Events Before the Week 24 Visit [ Time Frame: Baseline up to Week 24 ]
- Total Number of Participant Days of Combination Treatment With Pirfenidone and Nintedanib [ Time Frame: Baseline 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: Baseline up to Week 24 ]

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Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02598193

Study Director: | Clinical Trials | Hoffmann-La Roche |
Documents provided by Hoffmann-La Roche:
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT02598193 |
Other Study ID Numbers: |
MA29895 2015-003280-11 ( EudraCT Number ) |
First Posted: | November 5, 2015 Key Record Dates |
Results First Posted: | June 13, 2018 |
Last Update Posted: | June 13, 2018 |
Last Verified: | May 2018 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis Pathologic Processes Lung Diseases Respiratory Tract Diseases Pirfenidone Nintedanib Antineoplastic Agents Protein Kinase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action 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 |