A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary Fibrosis
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)MedDRA version: 18.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2015-003280-11-ES
- Lead Sponsor
- Roche Farma S.A., que representa en España a F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
?Male or female, and age 40 through 80 years old
?At the start of screening, on pirfenidone for at least 16 weeks and on a stable dose for at least 28 days (in this study, a stable dose will be defined as 1602?2403 mg/d); 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
?Pulmonary function test results at screening, percent predicted forced vital capacity (FVC) >=50% and percent predicted carbon monoxide diffusing capacity (DLco) >= 30%
?For women of childbearing potential: agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of < 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 or use contraceptive measures and agreement to refrain from donating sperm during the treatment period and for at least for at least 3 months after the final Follow-up Visit
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44
- Clinical evidence of active infection
?In the 28 days before the start of screening, any new or ongoing moderate or severe adverse reaction considered by the Investigator to be related to pirfenidone, or an pirfenidone treatment interruption > 7 days for any reason
?Any condition that is likely to result in death in the 12 months after the start of screening
?Lung transplantation anticipated in the 12 months after the start of screening
?Known hypersensitivity to the active substance or any excipient of either pirfenidone or nintedanib
?Severe hepatic impairment, including end-stage liver disease
?Severe renal impairment, including end-stage renal disease requiring dialysis
?History or risk of gastrointestinal (GI) tract perforation
?History of unstable or deteriorating cardiac or pulmonary disease in the 6 months before the start of screening
?Electrocardiogram (ECG) with a heart-rate?corrected QT interval ? 500 milliseconds (ms) at screening, or a family or personal history of long QT syndrome
?Bleeding risk: genetic predisposition to bleeding, a hemorrhagic event in the 12 months before the start of screening, or abnormal laboratory coagulation parameters. Patients who require fibrinolysis, full-dose therapeutic anticoagulation, high-dose antiplatelet therapy, or other therapy that may substantially increase bleeding risk are excluded
?Use of strong CYP1A2 inhibitors, P-glycoprotein or CYP3A4 or their inducers in the 28 days before the start of screening
?History of 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, or an unwillingness to abstain from their use through the final Follow-up Visit
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method