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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01366209
• Date of registration: 02/06/2011
• Prospective Registration: No
• Primary sponsor: Genentech, Inc.
• Public title: Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF) ASCEND
• Scientific 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)
• Date of first enrolment: June 2011
• Target sample size: 555
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01366209
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: For additional information, call InterMune Medical Information Telephone: [phone]
• Affiliation: InterMune

Key inclusion & exclusion criteria

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



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: Pirfenidone

Drug: Placebo

Primary Outcome(s)

Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52 [Time Frame: 52 weeks]

Secondary ID(s)

PIPF-016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/03/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01366209