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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02598193
• Date of registration: 04/11/2015
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: Safety and Tolerability Study of Pirfenidone in Combination With Nintedanib in Participants With Idiopathic Pulmonary Fibrosis (IPF)
• Scientific 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
• Date of first enrolment: January 14, 2016
• Target sample size: 89
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02598193
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Canada, Denmark, France, Germany, Italy, Netherlands, Spain, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

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



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: Nintedanib

Drug: Pirfenidone

Primary Outcome(s)

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 Outcome(s)

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]

Percentage of Participants With Adverse Events and Serious Adverse Events [Time Frame: Baseline up to Week 28]

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]

Secondary ID(s)

2015-003280-11

MA29895

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/06/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02598193