Idiopathic Pulmonary Fibrosis
Conditions
Keywords
idiopathic, pulmonary, fibrosis
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.
Interventions
DRUGpirfenidone
Pirfenidone, 2403 mg/d, administered as 801-mg doses, three times daily.
Sponsors
Hoffmann-La Roche
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 84 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pirfenidone Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily. | 1,058 |
| Total | 1,058 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 358 |
| Overall Study | Continued treatment | 5 |
| Overall Study | Death | 95 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Lung transplantation | 44 |
| Overall Study | Physician Decision | 19 |
| Overall Study | Reason not specified | 3 |
| Overall Study | Sponsor decision | 1 |
| Overall Study | Withdrawal by Subject | 83 |
| Overall Study | Withdrawn consent | 22 |
Baseline characteristics
| Characteristic | Pirfenidone |
|---|---|
| Age, Continuous | 68.5 years STANDARD_DEVIATION 7.47 |
| Sex: Female, Male Female | 268 Participants |
| Sex: Female, Male Male | 790 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1,027 / 1,058 |
| serious Total, serious adverse events | 571 / 1,058 |
Outcome results
Primary
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.
Time frame: 7.5 years
Population: All participants who received any pirfenidone.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pirfenidone | Percentage of Participants With Adverse Events | 98.0 percentage of participants |