Idiopathic Pulmonary FibrosisPhase 3PIPF-012NCT00662038
Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 3 study testing pirfenidone in people with Idiopathic Pulmonary Fibrosis, run by Genentech, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 84 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- pirfenidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,058 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Feb 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Genentech, Inc.
South San Francisco, California, 94080-4990
About this study
Official title: An Open-Label Extension Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
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.
Read the 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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- pirfenidone
- Keywords
- idiopathic, pulmonary, fibrosis
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pirfenidoneDrug
Pirfenidone, 2403 mg/d, administered as 801-mg doses, three times daily.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | pirfenidone Receives: Drug: pirfenidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startAug 2008
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,058 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662038
- Sponsor's protocol ID
- PIPF-012
- Other IDs
- GA29960
- Acronym
- PIPF-012
- Status last verified
- Feb 2017
- First submitted
- 17 Apr 2008
- Last updated
- 29 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Behr J, Nathan SD, Costabel U, Albera C, Wuyts WA, Glassberg MK, Haller H Jr, Alvaro G, Gilberg F, Samara K, Lancaster L. Efficacy and Safety of Pirfenidone in Advanced Versus Non-Advanced Idiopathic Pulmonary Fibrosis: Post-Hoc Analysis of Six Clinical Studies. Adv Ther. 2023 Sep;40(9):3937-3955. doi: 10.1007/s12325-023-02565-3. Epub 2023 Jun 30.
PubMed 37391667Maher 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.
PubMed 30950636Costabel 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.
PubMed 28898890Lancaster 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.
PubMed 26835133
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
- ClinicalTrials.gov ID
- NCT00662038
- Acronym / sponsor ID
- PIPF-012 / PIPF-012
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- idiopathic, pulmonary, fibrosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,058 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche
- Study start
- Aug 2008
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 21 Apr 2008 (estimated)
- Results
- Posted 29 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: pirfenidonepirfenidone |
Who may qualify
- Ages
- 40 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pirfenidonePirfenidone, 2403 mg/d, administered as 801-mg doses, three times daily. | Drug | Treatment |
Primary outcome
Percentage of Participants With Adverse Events
Time frame: 7.5 years
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37391667Behr J, Nathan SD, Costabel U, Albera C, Wuyts WA, Glassberg MK, Haller H Jr, Alvaro G, Gilberg F, Samara K, Lancaster L. Efficacy and Safety of Pirfenidone in Advanced Versus Non-Advanced Idiopathic Pulmonary Fibrosis: Post-Hoc Analysis of Six Clinical Studies. Adv Ther. 2023 Sep;40(9):3937-3955. doi: 10.1007/s12325-023-02565-3. Epub 2023 Jun 30.
- Derived from this study: PubMed 30950636Maher 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.
- Derived from this study: PubMed 28898890Costabel 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.
- Derived from this study: PubMed 26835133Lancaster 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pirfenidone in people with Idiopathic Pulmonary Fibrosis, run by Genentech, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Adverse Events (time frame: 7.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00662038, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.