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Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF) (PIPF-012)

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00662038
First received: April 17, 2008
Last updated: February 9, 2017
Last verified: February 2017
Results First Received: February 9, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Idiopathic Pulmonary Fibrosis
Intervention: Drug: pirfenidone

  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
No text entered.

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
Pirfenidone Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.

Participant Flow:   Overall Study
    Pirfenidone
STARTED   1058 
COMPLETED   427 
NOT COMPLETED   631 
Reason not specified                3 
Withdrawn consent                22 
Withdrawal by Subject                83 
Sponsor decision                1 
Physician Decision                19 
Lung transplantation                44 
Lost to Follow-up                1 
Death                95 
Adverse Event                358 
Continued treatment                5 



  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.
All treated participants

Reporting Groups
  Description
Pirfenidone Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.

Baseline Measures
   Pirfenidone 
Overall Participants Analyzed 
[Units: Participants]
 1058 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.5  (7.47) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      268  25.3% 
Male      790  74.7% 


  Outcome Measures

1.  Primary:   Percentage of Participants With Adverse Events   [ Time Frame: 7.5 years ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800 821-8590
e-mail: genentech@druginfo.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00662038     History of Changes
Other Study ID Numbers: PIPF-012
GA29960 ( Other Identifier: Genentech )
Study First Received: April 17, 2008
Results First Received: February 9, 2017
Last Updated: February 9, 2017