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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.

Tracking Information
First Submitted Date  ICMJE June 2, 2011
First Posted Date  ICMJE June 3, 2011
Results First Submitted Date  ICMJE February 27, 2015
Results First Posted Date  ICMJE March 12, 2015
Last Update Posted Date April 5, 2017
Study Start Date  ICMJE June 2011
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2015)		 Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52 [ Time Frame: 52 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 2, 2011)		 Change in percent predicted forced vital capacity (%FVC) [ Time Frame: 52 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Official Title  ICMJE A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (ASCEND Trial)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Pulmonary Fibrosis
Intervention  ICMJE
  • Drug: Pirfenidone
    Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
  • Drug: Placebo
    Placebo equivalent given as 3 divided doses 3 times per day.
Study Arms  ICMJE
  • Active Comparator: Active Arm
    Intervention: Drug: Pirfenidone
  • Placebo Comparator: Placebo Arm
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 21, 2014)		 555
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2011)		 500
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01366209
Other Study ID Numbers  ICMJE PIPF-016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Genentech, Inc.
Original Responsible Party InterMune Inc., Sponsor, InterMune Inc.
Current Study Sponsor  ICMJE Genentech, Inc.
Original Study Sponsor  ICMJE InterMune
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: For additional information, call InterMune Medical Information Telephone: 1-888-486-6411 InterMune
PRS Account Genentech, Inc.
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP