A Phase 4 interventional study of Pirfenidone and Placebos in Sarcoidosis, Pulmonary, sponsored by University of Cincinnati. Status unknown at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-09-28.
Sponsored by University of Cincinnati · Phase 4, Interventional, and Treatment
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Among 33 studies in Sarcoidosis, Pulmonary with a site in United States — 7 open to participants now, 8 under way, none of them phase 3. Sarcoidosis, Pulmonary · United States.
Among the 33 studies in Sarcoidosis, Pulmonary with a site in United States, this one is the 9th largest by planned enrollment of the 27 interventional ones that give a count, is one of 2 that started in 2017, is one of 3 in phase 4, and was the 17th registered.
67 studies on the registry are indexed under Sarcoidosis, Pulmonary; 16 are open to participants now.
Browse Sarcoidosis, Pulmonary studies →7 of the 33 studies in Sarcoidosis, Pulmonary with a site in United States are open now. Recruiting first, the newest first:
Merck Sharp & Dohme LLC · Sites in United States
Ages 18–75
Molecure S.A. · Sites in United States, Denmark, France and 5 more countries
Ages 18+
University of Pennsylvania · Sites in United States
Ages 18–80
University of California, San Francisco · Sites in United States
Ages 19+
National Jewish Health · Sites in United States
Ages 18–85
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 12 Sarcoidosis, Pulmonary studies recruiting now, 7 (58%) set no upper age limit and 1 (8%) stops at 75 or younger; 2 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
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33 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 15 · Phase 3 2 · Phase 4 3
First in 1996; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is close to the median of 55 across 50 interventional studies indexed under Sarcoidosis, Pulmonary.
Median enrollment 37 across the 27 interventional studies, 105 across the 6 observational. Of the 23 that completed or were terminated, 11 (48%) have results posted.
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16 of 33 have an industry lead sponsor. The 10 most frequent:
University of Cincinnati is the lead sponsor of 324 studies on the registry; 42 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 15 (63%) have results posted.
University of Cincinnati has 3 studies filed under Sarcoidosis, Pulmonary — fewer than ten, so there is no comparison to draw.
2 of the studies in Sarcoidosis, Pulmonary with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07613216Cosmos Rx, IncA Comparison of a Medication Adherence Platform (FORTISKAP™) vs. Usual Care in Subjects on Oral Medications for the Treatment of Interstitial Lung Disease, Sarcoid and Pulmonary Hypertension | 2027-07 |
| NCT06205121Molecure S.A.Efficacy and Safety Study of OATD-01 in Patients With Active Pulmonary Sarcoidosis | 2027-08 |
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Among the 33 studies in Sarcoidosis, Pulmonary with a site in United States, from their registry updates:
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Study comparing pirfenidone versus placebo for patients with advanced fibrotic sarcoidosis
Patients who meet the inclusion and exclusion criteria will be randomized to be treated with either placebo or pirfenidone at the current approved dosage for idiopathic pulmonary fibrosis at a 2:1 pirfenidone to placebo ratio. Patients treated with pirfenidone will be titrated using the following schedule:
One 267 mg capsules three times a day for two weeks. Two 267 mg capsules three times a day for two weeks Three 267 mg capsules three times a day thereafter Patients will be instructed to take all doses of medication with food. Dosage will be titrated on an individual basis depending on patient tolerance of medication.
Those randomized to placebo will receive the same schedule using placebo tablets.
Block randomization will be done at each site. Liver function tests will be evaluated as listed above. If the patient has an abnormal liver function test, then the dose will be adjusted per the company's protocol for commercial drug.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pirfenidone titrated to three 267 mg tablets three times a day
Drug: Pirfenidone
Placebo titrated to three tablets three times a day
Drug: Placebos
Increasing doses
Also known as: esbriet
Increasing doses
Also known as: placebo
Time until clinical worsening (TCW)
TCW
Time frame: two years
Change in forced vital capacity (FVC)
Change in forced vital capacity
Time frame: two years
Change in CPI
Change in composite physiologic index
Time frame: two years
Plan to share: Undecided — no plans yet
No publications or documents are linked to this record.
Started Sep 2017 (actual). Primary completion is estimated for Dec 2019, 27 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pirfenidone