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

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
pirfenidone
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring idiopathic, pulmonary, fibrosis

Eligibility Criteria

40 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Completes the qualifying clinical study final visit
  • In the opinion of the principal investigator (PI), has been generally compliant with study requirements during the qualifying study, or must be considered eligible to enroll in PIPF-012 by the InterMune medical monitor
  • Is able to provide informed consent and comply with the requirements of the study

Exclusion Criteria:

  • Is pregnant or lactating
  • Has known hypersensitivity to any of the components of the study drug
  • Starts participation in another interventional clinical trial between the end of participation in the qualifying InterMune clinical trial and entry into PIPF-012
  • Receives concomitant and/or excluded medications as defined in the protocol
  • Permanently discontinues study drug during the qualifying study for any reason before study completion

Sites / Locations

  • Genentech, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

pirfenidone

Outcomes

Primary Outcome Measures

Percentage of Participants With Adverse Events
An adverse event defined as any unfavorable, harmful, or pathologic change in a research participant administered a pharmaceutical study treatment as indicated by physical signs, symptoms, and/or clinically significant laboratory abnormalities that occurred during the treatment and the post-treatment period, regardless of suspected cause.

Secondary Outcome Measures

Full Information

First Posted
April 17, 2008
Last Updated
February 9, 2017
Sponsor
Genentech, Inc.
Collaborators
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00662038
Brief Title
Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Acronym
PIPF-012
Official Title
An Open-Label Extension Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
Collaborators
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open-label, multi-center, extension study for patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone. The purpose of this study is to obtain additional safety data for pirfenidone 2403 mg/day in patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone.
Detailed Description
This is an open-label, multi-center, extension study for patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone. Eligible patients must complete the final visit for their qualifying study, have not permanently discontinued study drug in their qualifying study, and meet all of the eligibility criteria noted in this protocol. Since data from the qualifying study may remain blinded during patient enrollment in PIPF-012, all patients will be treated as if they were taking placebo in their qualifying study. At the start of PIPF-012 participation, each patient will escalate the dose of pirfenidone. The duration of treatment for each patient will vary and will continue until pirfenidone is commercially or otherwise available in his/her geographic region or the study is terminated by the sponsor for reasons outlined in the protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
idiopathic, pulmonary, fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1058 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
pirfenidone
Intervention Type
Drug
Intervention Name(s)
pirfenidone
Intervention Description
Pirfenidone, 2403 mg/d, administered as 801-mg doses, three times daily.
Primary Outcome Measure Information:
Title
Percentage of Participants With Adverse Events
Description
An adverse event defined as any unfavorable, harmful, or pathologic change in a research participant administered a pharmaceutical study treatment as indicated by physical signs, symptoms, and/or clinically significant laboratory abnormalities that occurred during the treatment and the post-treatment period, regardless of suspected cause.
Time Frame
7.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completes the qualifying clinical study final visit In the opinion of the principal investigator (PI), has been generally compliant with study requirements during the qualifying study, or must be considered eligible to enroll in PIPF-012 by the InterMune medical monitor Is able to provide informed consent and comply with the requirements of the study Exclusion Criteria: Is pregnant or lactating Has known hypersensitivity to any of the components of the study drug Starts participation in another interventional clinical trial between the end of participation in the qualifying InterMune clinical trial and entry into PIPF-012 Receives concomitant and/or excluded medications as defined in the protocol Permanently discontinues study drug during the qualifying study for any reason before study completion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Genentech, Inc.
City
South San Francisco
State/Province
California
ZIP/Postal Code
94080-4990
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30950636
Citation
Maher TM, Lancaster LH, Jouneau S, Morrison L, Lederer DJ, Molina-Molina M, Bendstrup E, Kirchgaessler KU, Gilberg F, Axmann J, Petzinger U, Noble PW. Pirfenidone Treatment in Individuals with Idiopathic Pulmonary Fibrosis: Impact of Timing of Treatment Initiation. Ann Am Thorac Soc. 2019 Jul;16(7):927-930. doi: 10.1513/AnnalsATS.201810-720RL. No abstract available.
Results Reference
derived
PubMed Identifier
28898890
Citation
Costabel U, Albera C, Lancaster LH, Lin CY, Hormel P, Hulter HN, Noble PW. An Open-Label Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (RECAP). Respiration. 2017;94(5):408-415. doi: 10.1159/000479976. Epub 2017 Sep 13.
Results Reference
derived
PubMed Identifier
26835133
Citation
Lancaster L, Albera C, Bradford WZ, Costabel U, du Bois RM, Fagan EA, Fishman RS, Glaspole I, Glassberg MK, King TE Jr, Lederer DJ, Lin Z, Nathan SD, Pereira CA, Swigris JJ, Valeyre D, Noble PW. Safety of pirfenidone in patients with idiopathic pulmonary fibrosis: integrated analysis of cumulative data from 5 clinical trials. BMJ Open Respir Res. 2016 Jan 12;3(1):e000105. doi: 10.1136/bmjresp-2015-000105. eCollection 2016.
Results Reference
derived

Learn more about this trial

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

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