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Efficacy, Safety, and Tolerability Study of Pirfenidone in Combination With Sildenafil in Participants With Advanced Idiopathic Pulmonary Fibrosis (IPF) and Intermediate or High Probability of Group 3 Pulmonary Hypertension
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
40 Years - 80 Years
Gender
All
More Inclusion & Exclusion Criteria
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
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Phase 2
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Hoffmann-La Roche
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
Clinical Trials
Principal Investigator Affiliation
Hoffmann-La Roche
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Idiopathic Pulmonary Fibrosis
Arms & Interventions
Arms
Placebo Comparator: Pirfenidone + Placebo
Participants will receive pirfenidone along with placebo matched to sildenafil, orally, three times a day (TID) for 52 weeks.
Experimental: Pirfenidone + Sildenafil
Participants will receive pirfenidone along with sildenafil, orally, TID for 52 weeks.
Interventions
Drug: - Pirfenidone
Pirfenidone will be given in the range of 1602 to 2403 milligram per day (mg/day), as 3 divided doses.
Drug: - Placebo
Placebo matched with sildenafil.
Drug: - Sildenafil
Sildenafil will be given as 20 mg, TID.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
