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Efficacy, Safety, and Tolerability Study of Pirfenidone in Combination With Sildenafil in Participants With Advanced Idiopathic Pulmonary Fibrosis (IPF) and Risk of Group 3 Pulmonary Hypertension
Respiratory Disorder Idiopathic Pulmonary Fibrosis (IPF)
Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Study Identifier
NCT02951429, MA29957, 2015-005131-40
Condition
Idiopathic Pulmonary Fibrosis
Official Title
A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients With Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Group 3 Pulmonary Hypertension
Study Summary
This Phase IIb, randomized, placebo-controlled, multicenter, international study will evaluate the efficacy, safety, and tolerability of sildenafil or placebo added to pirfenidone (Esbriet) treatment in participants with advanced IPF and intermediate or high probability of Group 3 pulmonary hypertension (PH) who are on a stable dose of pirfenidone with demonstrated tolerability. Participants will be randomized to receive 1 year of treatment with either oral sildenafil or matching placebo while continuing to take pirfenidone.
Eligibility Criteria
All
≥ 40 Years & ≤ 80 Years
No
Inclusion Criteria
- Diagnosis of IPF for at least 3 months prior to Screening
- Confirmation of IPF diagnosis by the investigator in accordance with the 2011 international consensus guidelines at screening
- Advanced IPF (defined as a measurable carbon monoxide diffusing capacity [DLCO] less than or equal to (<=)40% of predicted value at Screening) and intermediate or high probability of group 3 pulmonary hypertension (PH)
- Participants receiving pirfenidone for at least 12 weeks, at a dose in the range of 1602 to 2403 mg/day for at least 4 weeks prior to Screening and must not have experienced either a new or ongoing adverse event of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (version 4.03) Grade 2 or higher and considered by the investigator to be related to pirfenidone, or an interruption of pirfenidone treatment of greater than (>)7 days for any reason
- WHO Functional Class II or III at Screening
- 6MWD of 100 to 450 meters at screening
- Women of childbearing potential and for men who are not surgically sterile agreement to remain abstinent or use of contraceptive measures
Exclusion Criteria
- History of any of the following types of PH: Group 1 (PAH); Group 1 (pulmonary veno-occlusive disease and/or pulmonary capillary hemangiomatosis); Group 2 (left-heart disease); Group 3 (due to conditions other than interstitial lung disease, including chronic obstructive pulmonary disease [COPD], sleep-disordered breathing, alveolar hypoventilation, high altitude, or developmental abnormalities); Group 4 (chronic thromboembolic pulmonary hypertension); Group 5 (other disorders)
- History of clinically significant cardiac disease
- History of coexistent and clinically significant COPD, bronchiectasis, asthma, inadequately treated sleep-disordered breathing, or any clinically significant pulmonary diseases or disorders other than IPF or PH secondary to IPF
- History of use of drugs and toxins known to cause PAH, including aminorex, fenfluramine, dexenfluramine, and amphetamines
- FEV1/FVC ratio less than (<) 0.70 post bronchodilator; SpO2 saturation at rest <92% with >= 6 liters (L) of supplemental oxygen at Screening
- Extent of emphysema greater than the extent of fibrotic changes (honeycombing and reticular changes) on any previous high-resolution computed tomography (HRCT) scan, in the opinion of the Investigator
- Smoked tobacco within 3 months prior to screening or is unwilling to avoid tobacco products (cigarettes, pipe, cigars) throughout the study
- Illicit drug or significant alcohol abuse
- Electrocardiogram (ECG) with a heart-rate corrected QT interval (corrected using Fridericia's formula [QTcF]) >=500 milliseconds (ms) at screening, or a family or personal history of long QT syndrome
- Exclusion criteria based on pirfenidone reference safety information: 1. participants with a history of angioedema due to pirfenidone; 2. concomitant use of fluvoxamine
- Exclusion criteria based on sildenafil reference safety information: 1. co-administration with nitric oxide donors or organic nitrates, phosphodiesterase-5 (PDE5) inhibitors, guanylate cyclase stimulators, and most potent of the Cytochrome P450 3A4 (CYP3A4) inhibitors; 2. loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION); 3. use of an alpha-blocker; 4. participants with bleeding disorders or active peptic ulceration; 5. known hereditary degenerative retinal disorders such as retinitis pigmentosa; 6. galactose intolerance
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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Study results
LPS NCT02951429 Aug2020 French Belgium
(PDF, 0.5 MB)
LPS NCT02951429 Aug2020 Dutch Belgium
(PDF, 0.6 MB)
LPS NCT02951429 Aug2020 English
(PDF, 1.9 MB)
LPS NCT02951429 Aug2020 Arabic Egypt
(PDF, 0.7 MB)
LPS NCT02951429 Aug2020 Greek
(PDF, 0.4 MB)
LPS NCT02951429 Nov2020 Arabic Israel
(PDF, 0.8 MB)
LPS NCT02951429 Nov2020 Hebrew Israel
(PDF, 3.1 MB)
LPS NCT02951429 Nov2020 Russian Israel
(PDF, 0.4 MB)
LPS NCT02951429 Oct2020 Dutch Netherlands
(PDF, 1.0 MB)
LPS NCT02951429 Aug2020 French Canada
(PDF, 1.7 MB)
LPS NCT02951429 Nov2020 Czech
(PDF, 2.0 MB)
LPS NCT02951429 Oct2020 German
(PDF, 0.8 MB)
LPS NCT02951429 Sept2020 Hungarian
(PDF, 0.9 MB)
LPS NCT02951429 Aug2020 Italian
(PDF, 1.2 MB)
LPS NCT02951429 Aug2020 Spanish
(PDF, 0.5 MB)
LPS NCT02951429 Nov2020 Turkey
(PDF, 1.5 MB)
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For the latest version of this information please go to www.forpatients.roche.com