Studio di estensione in aperto sulla sicurezza a lungo termine del pirfenidone nei pazienti con fibrosi polmonare idiopatica (FPI) che hanno completato gli studi CAPACITY - ND
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)MedDRA version: 9.1Level: LLTClassification code 10021240Term: Idiopathic pulmonary fibrosis
- Registration Number
- EUCTR2007-007800-13-IT
- Lead Sponsor
- INTERMUNE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 750
Each patient must fulfill all of the following criteria to be
eligible for enrollment into the study:
1. Completes the CAPACITY studies Final Follow-Up
Visit.
2. In the opinion of the principal investigator (PI), has
been at least 80% compliant with taking the study
drug at the time of the CAPACITY Treatment
Completion Visit, or must obtain permission from
the InterMune medical monitor
3. Is able to provide informed consent and comply
with the requirements of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
A patient with any of the following will be excluded from the
study:
1. Is pregnant or lactating. Women of childbearing
capacity are required to have a negative serum
pregnancy test before treatment and must agree to
maintain highly effective methods of contraception
by practicing abstinence or by using at least two
methods of birth control from the date of consent
through the end of the study. If abstinence is not
practiced, then one of the two methods of birth
control should be an oral contraceptive (e.g., oral
contraception and a spermicide)
2. Has known hypersensitivity to any of the
components of the study drug
3. In the opinion of the PI, is not a suitable candidate
for study participation. The PI should carefully
consider the risks and benefits of treatment if the
patient?s medical status has declined significantly
during participation in CAPACITY. The exclusion
criteria from the CAPACITY studies are provided in
Appendix C for reference
4. Participates in another interventional clinical trial
between the end of participation in either PIPF-004
or PIPF-006 and planned entry into PIPF-012.
5. Receives the following therapies within 28 days of
the first dose of pirfenidone in this study (Day 1):
a. Investigational therapy, defined as any drug that
has not been approved for marketing for any
indication in the country of the participating site
b. Angiotensin-converting enzyme (ACE)-
inhibitors, colchicine, warfarin, heparin,
sildenafil, and hydroxymethylglutarylcoenzyme
A (HMG-CoA) reductase inhibitors.
These drugs may be used if given for a non-IPF
indication if there is no clinically acceptable
alternative therapy for the same indication.
c. Any cytotoxic, immunosuppressive, cytokinemodulating,
or receptor antagonist agent,
including but not limited to the following:
bosentan, cyclosporine, etanercept, iloprost,
infliximab, leukotrienes, methotrexate,
mycophenolate mofetil, sildenafil (daily),
tetrathiomolybdate, tumor necrosis factor alpha
(TNF-α) inhibitors, N-acetylcysteine (NAC)
alone, imatinib mesylate, Interferon gamma-1b
(IFN-γ 1b), and tyrosine kinase inhibitors. These
drugs may be used if given for a non-IPF indication if there is no clinically acceptable
alternative therapy for the same indication.
Note: the exceptions are (a) corticosteroids,
azathioprine, and/or cyclosphosphamide at
doses specified in the American Thoracic
Society/European Respiratory Society
(ATS/ERS) 2005 Guidelines and (b) NAC in
combination with prednisone and azathioprine.
6. Permanently discontinues study drug during the
CAPACITY studies for any reason
7. Meets any of the following liver function test
criteria above specified limits at the CAPACITY Treatment Completion Visit: total bilirubin >2.5 × upper limit of normal (ULN); aspartate or alanine aminotransferases (AST/SGOT or
ALT/SGPT) >2.5 × ULN; alkaline phosphatase >2.5 × ULN
8. Has an ECG from the CAPACITY Study Treatment Completion Visit or from the PIPF-012 Day 1 Visit with a heart-rate?corrected (using Bazett?s formula)
QT interval (QTcB) of >500 ms or must obtain permission from the InterMune medical monitor.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Obtain additional safety data for pirfenidone 2403 mg/d in<br>patients with IPF who complete either Study PIPF-004 or<br>PIPF-006.;Secondary Objective: Obtain additional efficacy data for pirfenidone 2403 mg/d and<br>provide access to pirfenidone for qualifying patients who<br>complete the PIPF-004 or PIPF-006 studies.;Primary end point(s):
- Secondary Outcome Measures
Name Time Method