Sarcoidosis, PulmonaryPhase 4PirFSNCT03260556
Pirfenidone for Progressive Fibrotic Sarcoidosis
A Phase 4 study testing Pirfenidone in people with Sarcoidosis, Pulmonary, run by University of Cincinnati at 1 site in United States.
Trial summary
Study comparing pirfenidone versus placebo for patients with advanced fibrotic sarcoidosis Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sarcoidosis, Pulmonary
- What is being tested?
- Pirfenidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2017to 30 Mar 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of sarcoidosis
- Pulmonary function testing with a Composite Physiologic Index (CPI) score of greater than 40
- Patient must have evidence of >20% fibrosis on high resolution cat scan
- Patients must be on a stable prednisone therapy for sarcoidosis for at least two months and no change in other immunosuppressives in the two months prior to entry into study
- Age greater than 18 and less than 90.
- Able to provide written informed consent for participation in the study
Who cannot join
- Patients receiving therapy for precapillary pulmonary hypertension.
- Patients with liver disease Childs class 3 or 4
- Patients with a left ventricular ejection fraction of less than 40%
- Patients receiving more than 20 mg prednisone daily or its equivalent
- Patients with massive hemoptysis within prior three months. Patients with mycetomas are eligible as long as no massive hemoptysis in prior three months.
- Patients with clinically important co-existing disease which in the opinion of the investigator is likely to affect patient's chance for survival during the course of the study
- Patient who is pregnant, lactating, intending to become pregnant during the study, or child bearing capacity who is not willing to use appropriate birth control methods approved by investigator
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45267
Robert P Baughman, MD, 513-584-5225, bob.baughman@uc.edu
Elyse E Lower, 513-584-3829, ELower@ucmail.uc.edu
About this study
Study comparing pirfenidone versus placebo for patients with advanced fibrotic sarcoidosis
Read the detailed description
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.
- Conditions
- Sarcoidosis, Pulmonary
- Being tested
- Pirfenidone, Placebos
- Keywords
- pulmonary fibrosis
- Medical subject headings
- Sarcoidosis, Pulmonary, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirfenidoneDrug
Also called esbriet
Increasing doses
PlacebosDrug
Also called placebo
Increasing doses
| Study group | Role | What they receive |
|---|---|---|
| Pirfenidone | Active comparator | Pirfenidone titrated to three 267 mg tablets three times a day Receives: Drug: Pirfenidone |
| Placebos | Placebo comparator | Placebo titrated to three tablets three times a day Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until clinical worsening (TCW)
TCW
Measured: two years
Secondary outcomes (2)
Change in forced vital capacity (FVC)
Change in forced vital capacity
Measured: two years
Change in CPI
Change in composite physiologic index
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start27 Sep 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion30 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcoidosis, PulmonaryStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind placebo controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust
- Responsible party
- Principal investigator, Robert P Baughman, University of Cincinnati
- Investigators
- Robert P Baughman, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260556
- Sponsor's protocol ID
- 2016-5706
- Acronym
- PirFS
- Status last verified
- Sep 2017
- First submitted
- 22 Aug 2017
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: no plans yet
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pirfenidone for Progressive Fibrotic Sarcoidosis
- ClinicalTrials.gov ID
- NCT03260556
- Acronym / sponsor ID
- PirFS / 2016-5706
- Conditions
- Sarcoidosis, Pulmonary
- Keywords
- pulmonary fibrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust
- Study start
- 27 Sep 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 Mar 2020 (estimated)
- First posted
- 24 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study comparing pirfenidone versus placebo for patients with advanced fibrotic sarcoidosis
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double blind placebo controlled trial
| Arm | Type | Receives |
|---|---|---|
| Pirfenidone | Active comparator | Drug: PirfenidonePirfenidone titrated to three 267 mg tablets three times a day |
| Placebos | Placebo comparator | Drug: PlacebosPlacebo titrated to three tablets three times a day |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of sarcoidosis
- Pulmonary function testing with a Composite Physiologic Index (CPI) score of greater than 40
- Patient must have evidence of >20% fibrosis on high resolution cat scan
- Patients must be on a stable prednisone therapy for sarcoidosis for at least two months and no change in other immunosuppressives in the two months prior to entry into study
- Age greater than 18 and less than 90.
Key exclusion criteria (7 listed)
- Patients receiving therapy for precapillary pulmonary hypertension.
- Patients with liver disease Childs class 3 or 4
- Patients with a left ventricular ejection fraction of less than 40%
- Patients receiving more than 20 mg prednisone daily or its equivalent
- Patients with massive hemoptysis within prior three months. Patients with mycetomas are eligible as long as no massive hemoptysis in prior three months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PirfenidoneAlso: esbrietIncreasing doses | Drug | Pirfenidone |
| PlacebosAlso: placeboIncreasing doses | Drug | Placebos |
Primary outcome
Time until clinical worsening (TCW)
Time frame: two years
TCW
2 secondary outcomes
Change in forced vital capacity (FVC)
Time frame: two years
Change in CPI
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
- Individual participant dataSharing planned: Undecided. no plans yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert P Baughman, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pirfenidone in people with Sarcoidosis, Pulmonary, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert P Baughman, MD (513-584-5225, baughmrp@ucmail.uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time until clinical worsening (TCW) (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2017.