An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies - Open-Label Extension of Pirfenidone CAPACITY Studies

• Register: EUCTR
• Last refreshed on: 23 January 2017
• Main ID: EUCTR2007-007800-13-IE
• Date of registration: 07/02/2008
• Prospective Registration: Yes
• Primary sponsor: InterMune, Inc.
• Public title: An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies - Open-Label Extension of Pirfenidone CAPACITY Studies
• Scientific title: An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies - Open-Label Extension of Pirfenidone CAPACITY Studies
• Date of first enrolment: 04/06/2008
• Target sample size: 750
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-007800-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, France, Germany, Ireland, Italy, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Each patient who meets all of the following criteria is eligible to participate in the study:

1. Completes the CAPACITY studies Final Follow-Up Visit

2. In the opinion of the 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

Exclusion criteria:
Any patient who meets any of the following criteria is not eligible to participate in 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.

4. Participates in another interventional clinical trial between the end of participation in the CAPACITY studies 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 hydroxymethylglutaryl-coenzyme 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, cytokine modulating, or receptor antagonist agent including but not limited to:

bosentan, cyclosporine, etanercept, iloprost, infliximab, leukotrienes, methotrexate, mycophenolate mofetil, sildenafil (daily), tetrathiomolybdate, TNF-a inhibitors, N-acetylcysteine (NAC) alone, imatinib mesylate, Interferon gamma-1b (IFN g 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 ATS/ERS 2005 Guidelines and (b) NAC in combination with prednisone and azathioprine.

6. Permanently discontinues study drug in 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 x upper limit of normal (ULN); aspartate or alanine aminotransferases (AST/SGOT or ALT/SGPT) >2.5 x ULN; alkaline phosphatase >2.5 x ULN

8. Has an ECG from a CAPACITY Trials Treatment Completion Visit or from the PIPF-012 Day 1 Visits showing heart-rate–correct (using Bazett’s formula) QT (QTcB) interval >500 ms or must obtain permission from the InterMune medical monitor



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 9.1 Level: LLT Classification code 10021240 Term: Idiopathic pulmonary fibrosis

Intervention(s)

Product Name: Pirfenidone
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pirfenidone
Current Sponsor code: 53179-13-8
Other descriptive name: PIR, S-7701
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 267-

Primary Outcome(s)

Main Objective: The primary objective of this study is to obtain additional safety data for Pirfenidone 2403 mg/d in patients with Idiopathic Pulmonary Fibrosis (IPF) who complete either study PIPF-004 or PIPF-006.

Primary end point(s): Not applicable to an extension trial of this kind

Secondary Objective: The secondary objectives are to obtain additional efficacy data for Pirfenidone 2403 mg/d and to provide access to Pirfenidone for qualifying patients who complete the PIPF-004 or PIPF-006 studies.

Secondary ID(s)

PIPF-012