Phase 3
N=555
Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT01366209 ↗Enrolled (actual)
555
Serious AEs
22.3%
Results posted
Mar 2015
Primary outcome: Primary: Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52 — 16.5; 31.8; 22.7; 9.7 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pirfenidone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Genentech, Inc.
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52 |
16.5; 31.8; 22.7; 9.7 | — |
Summary
PIPF-016 (ASCEND) is a Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. The study objectives are to confirm the treatment effect of pirfenidone compared with placebo on change in percent predicted forced vital capacity (%FVC) in patients with idiopathic pulmonary fibrosis (IPF), and to confirm the safety of treatment with pirfenidone compared with placebo in patients with IPF.
Eligibility Criteria
Select Inclusion Criteria:
- Diagnosis of idiopathic pulmonary fibrosis (IPF), consistent with the ATS 2011 Guidelines, of 6-48 months' duration
- Age 40 to 80 at randomization
- Percent Forced Vital Capacity (%FVC) ≥50% and ≤90% at screening
- Percent Carbon Monoxide Diffusing Capacity (%DLCO) ≥30% and ≤90% at screening
Select Exclusion Criteria:
- Forced expiratory volume in one second (FEV1)/FVC ratio <0.8 after administration of bronchodilator at Screening
- Expected to receive a lung transplant within 1 year from randomization or, for patients at sites in the United States, on a lung transplant waiting list at randomization
- Known explanation for interstitial lung disease
- History of asthma or chronic obstructive pulmonary disease
- Active infection
- Ongoing IPF treatments including investigational therapy, immunosuppressants, and cytokine modulating agents
- History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months
Data sourced from ClinicalTrials.gov (NCT01366209). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.