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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01366209
First received: June 2, 2011
Last updated: February 27, 2015
Last verified: February 2015
Results First Received: February 27, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Idiopathic Pulmonary Fibrosis
Interventions: Drug: Pirfenidone
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Active Arm Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
Placebo Arm Placebo: Placebo equivalent given as 3 divided doses 3 times per day.

Participant Flow:   Overall Study
    Active Arm     Placebo Arm  
STARTED     278     277  
COMPLETED     243 [1]   241  
NOT COMPLETED     35     36  
Adverse Event                 6                 7  
Withdrawal by Subject                 4                 4  
Death                 12                 19  
Lung transplantation                 6                 1  
Lost to Follow-up                 2                 1  
Physician Decision                 1                 0  
Sponsors decision                 0                 1  
Withdrew consent                 4                 3  
[1] Participants completing study assessment at Week 52 were completers, even if treatment was withdrawn



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Active Arm Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
Placebo Arm Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
Total Total of all reporting groups

Baseline Measures
    Active Arm     Placebo Arm     Total  
Number of Participants  
[units: participants]
  278     277     555  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     73     88     161  
>=65 years     205     189     394  
Gender  
[units: participants]
     
Female     56     64     120  
Male     222     213     435  
Region of Enrollment  
[units: participants]
     
United States     187     184     371  
Australia     33     31     64  
Brazil     15     16     31  
Croatia     1     1     2  
Israel     11     9     20  
Mexico     12     5     17  
New Zealand     1     3     4  
Peru     18     26     44  
Singapore     0     2     2  



  Outcome Measures

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Elizabeth Fagan MD
Organization: InterMune
e-mail: Efagan@intermune.com


No publications provided by Genentech, Inc.

Publications automatically indexed to this study:

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01366209     History of Changes
Other Study ID Numbers: PIPF-016
Study First Received: June 2, 2011
Results First Received: February 27, 2015
Last Updated: February 27, 2015
Health Authority: United States: Food and Drug Administration