Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF) (ASCEND)
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| ClinicalTrials.gov Identifier: NCT01366209 |
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Recruitment Status :
Completed
First Posted : June 3, 2011
Results First Posted : March 12, 2015
Last Update Posted : April 5, 2017
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Sponsor:
Genentech, Inc.
Information provided by (Responsible Party):
Genentech, Inc.
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Idiopathic Pulmonary Fibrosis |
| Interventions |
Drug: Pirfenidone Drug: Placebo |
| Enrollment | 555 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Active Arm | Placebo Arm |
|---|---|---|
 Arm/Group Description |
Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day. | Placebo: Placebo equivalent given as 3 divided doses 3 times per day. |
| Period Title: Overall Study | ||
| Started | 278 | 277 |
| Completed | 243 [1] | 241 |
| Not Completed | 35 | 36 |
| Reason Not Completed | ||
| 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 |
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[1]
Participants completing study assessment at Week 52 were completers, even if treatment was withdrawn
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Baseline Characteristics
| Arm/Group Title | Active Arm | Placebo Arm | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day. | Placebo: Placebo equivalent given as 3 divided doses 3 times per day. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 278 | 277 | 555 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 278 participants | 277 participants | 555 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
73 26.3%
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88 31.8%
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161 29.0%
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| >=65 years |
205 73.7%
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189 68.2%
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394 71.0%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 278 participants | 277 participants | 555 participants | |
| Female |
56 20.1%
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64 23.1%
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120 21.6%
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| Male |
222 79.9%
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213 76.9%
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435 78.4%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 278 participants | 277 participants | 555 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
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Medical Communications |
| Organization: | Hoffmann-LaRoche |
| Phone: | 800-821-8590 |
| EMail: | genentech@druginfo.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT01366209 |
| Other Study ID Numbers: |
PIPF-016 |
| First Submitted: | June 2, 2011 |
| First Posted: | June 3, 2011 |
| Results First Submitted: | February 27, 2015 |
| Results First Posted: | March 12, 2015 |
| Last Update Posted: | April 5, 2017 |