E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Idiopathic Pulmonary Fibrosis (IPF) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021240 |
E.1.2 | Term | Idiopathic pulmonary fibrosis |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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 study drug 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, leukotriene-antagonists, methotrexate, mycophenolate mofetil, sildenafil (daily), tetrathiomolybdate, TNF-α 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
For UK sites only: 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Not applicable to an extension trial of this kind |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 33 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |