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

Idiopathic Pulmonary Fibrosis Clinical Trial

— ASCEND  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366209
• Other study ID #: PIPF-016
• Status: Completed
• Phase: Phase 3
• First received: June 2, 2011
• Last updated: May 7, 2015
• Start date: June 2011
• Est. completion date: February 2014

Study information

• Verified date: May 2015
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 555
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Select Inclusion Criteria:

1. Diagnosis of idiopathic pulmonary fibrosis (IPF), consistent with the ATS 2011 Guidelines, of 6-48 months' duration

2. Age 40 to 80 at randomization

3. Percent Forced Vital Capacity (%FVC) =50% and =90% at screening

4. Percent Carbon Monoxide Diffusing Capacity (%DLCO) =30% and =90% at screening

Select Exclusion Criteria:

1. Forced expiratory volume in one second (FEV1)/FVC ratio <0.8 after administration of bronchodilator at Screening

2. 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

3. Known explanation for interstitial lung disease

4. History of asthma or chronic obstructive pulmonary disease

5. Active infection

6. Ongoing IPF treatments including investigational therapy, immunosuppressants, and cytokine modulating agents

7. History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• Pirfenidone
Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
• Placebo
Placebo equivalent given as 3 divided doses 3 times per day.

Locations

Country	Name	City	State
United States	InterMune Inc.	Brisbane	California

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52		52 weeks	No