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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01366209
Recruitment Status : Completed
First Posted : June 3, 2011
Results First Posted : March 12, 2015
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: Pirfenidone Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 555 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : June 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Pirfenidone

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Active Arm Drug: Pirfenidone
Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
Placebo Comparator: Placebo Arm Drug: Placebo
Placebo equivalent given as 3 divided doses 3 times per day.


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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366209


Locations
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United States, California
InterMune Inc.
Brisbane, California, United States, 94005
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Chair: For additional information, call InterMune Medical Information Telephone: 1-888-486-6411 InterMune
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01366209    
Other Study ID Numbers: PIPF-016
First Posted: June 3, 2011    Key Record Dates
Results First Posted: March 12, 2015
Last Update Posted: April 5, 2017
Last Verified: March 2017
Keywords provided by Genentech, Inc.:
Pirfenidone
ASCEND
IPF
FVC
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Pirfenidone
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents