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Anti-fibrotic agent

Pirfenidone for Interstitial Lung Disease (PEARL Trial)

Phase 2
Waitlist Available
Led By Jesse Roman, MD
Research Sponsored by Jesse Roman
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Change in pre-bronchodilator FVC (measured in liters) between Screening (Visit 1)
100%*[absolute value (Screening FVC - Baseline FVC)/Screening FVC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights

PEARL Trial Summary

This trial will study the effects of pirfenidone on patients with Hermansky-Pudlak Syndrome who also have interstitial lung disease.

Eligible Conditions
  • Interstitial Lung Disease
  • Hermansky-Pudlak Syndrome

PEARL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

PEARL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in Diffusion Capacity (DLCO)
Change in Forced Vital Capacity (FVC)
Incidence of Treatment Emergent Adverse Events
+1 more

Side effects data

From 2017 Phase 4 trial • 105 Patients • NCT02579603
31%
Diarrhoea
16%
Dyspnoea
12%
Nausea
12%
Vomiting
12%
Fatigue
10%
Decreased appetite
8%
Abdominal pain upper
6%
Asthenia
6%
Weight decreased
6%
Abdominal pain
6%
Contusion
6%
Dizziness
6%
Cough
4%
Bronchitis
4%
Nasopharyngitis
2%
Atrial flutter
2%
Transient ischaemic attack
2%
Gastrooesophageal reflux disease
2%
Phlebitis
2%
Constipation
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Pyrexia
2%
Acute respiratory failure
2%
Pancreatitis acute
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nintedanib
Nintedanib + Pirfenidone

PEARL Trial Design

1Treatment groups
Experimental Treatment
Group I: Oral Pirfenidone 2403 mg per dayExperimental Treatment1 Intervention
Enrolled subjects will receive oral pirfenidone 801 mg taken three times a day. Pirfenidone will be supplied in 267 mg capsules.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pirfenidone
FDA approved

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,691 Total Patients Enrolled
Jesse RomanLead Sponsor
Jesse Roman, MDPrincipal InvestigatorThomas Jefferson University
3 Previous Clinical Trials
589 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still room for participation in this research endeavor?

"According to clinicaltrials.gov, this trial is not presently open for recruitment; having first been posted on December 1st 2019 and its last update being made on the 6th of that same month. Notwithstanding, there are currently 1677 other trials searching for participants."

Answered by AI

Can individuals aged 55 and over participate in this research?

"Patients 18 to 75 years old can participate in this trial. For those outside of that age range, there are 398 studies for minors and 1,264 trials available for seniors."

Answered by AI

Has this experiment been conducted before, or is it a novel endeavor?

"Currently, 11 cities and 5 countries are hosting 12 active trials involving Pirfenidone. Shanghai Genomics, Inc. initiated the first study in 2015 with 48 participants that eventually completed its Phase 2 clinical approval stage. Since then, an additional 44 experiments have been conducted to investigate the drug's efficacy further."

Answered by AI

Can you provide an overview of precedent research concerning Pirfenidone?

"Currently, 12 clinical trials are looking into the effectiveness of Pirfenidone. One is in its final testing stage, Phase 3. Primarily based in Mayaguez and Pennsylvania, 14 centers are conducting these studies."

Answered by AI

What is the enrollment count for this clinical research project?

"The recruitment period for this trial has ended. It was first publicized on December 1st 2019 and last revised on the 6th of that month. Currently, 1665 clinical trials related to diseases of the lungs are actively recruiting participants while 12 separate studies with Pirfenidone as an intervention remain open."

Answered by AI

What potential risks accompany the use of Pirfenidone?

"Pirfenidone attained a score of 2, as there is evidence that it can be safe but no proof yet of its efficacy."

Answered by AI

What criteria must an individual meet to be enrolled in this research?

"This clinical trial is seeking a cohort of 50 individuals, aged between 18 and 75 years old, with lung conditions. Furthermore, they must not have taken any cytotoxic or immunosuppressive drugs such as azathioprine, cyclophosphamide, cyclosporine etc., nor display any features suggestive of an alternative diagnosis like infection."

Answered by AI
~10 spots leftby Mar 2025