Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

InterMune Inc.

Brisbane, California, 94005, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pirfenidone

Drug

Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.

Placebo

Drug

Placebo equivalent given as 3 divided doses 3 times per day.

Primary outcomes

Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52

Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (ASCEND Trial)

Acronym: ASCEND

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Jun 3, 2011
Registry last updated: Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed