E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Idipathic Pulmonary Fibrosis |
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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 | 10001892 |
E.1.2 | Term | Alveolitis fibrosing |
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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 |
To assess long-term safety and tolerability of bosentan in patients with idiopathic pulmonary fibrosis (IPF) , who completed protocol AC-052-321 / BUILD 3. |
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E.2.2 | Secondary objectives of the trial |
- AEs leading to premature discontinuation of study drug.- Treatment-emergent SAEs and SAEs up to 28 days after the end of study drug treatment.- Occurrence of LFT (ALT and AST) abnormality (up to 24 hours after the end of study treatment): > 3 and ≤ 5 × ULN> 5 and ≤ 8 × ULN> 8 × ULN |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Before the release of the BUILD 3 results: Patients who have experienceda BUILD 3 protocol-defined event of IPF worsening and have had at least1 year of double-blind treatment in BUILD 3. If BUILD 3 shows positive results: all patients who have completedBUILD 3 have the option of entering this OL study within 2 months afterthe last visit in BUILD 3. Signed informed consent prior to initiation of any study-relatedprocedures. Women of childbearing potential must have a negative serum pregnancytest and use reliable methods of contraception during study treatment andfor 3 months after study treatment termination. Patients should have completed all the assessments from the BUILD 3EOS visit. |
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E.4 | Principal exclusion criteria |
Any major violation of protocol AC-052-321 / BUILD 3. Pregnancy or breast-feeding. AST and/or ALT > 3 times the upper limit of the normal range. Any known factor or disease that might interfere with treatmentcompliance, study conduct or interpretation of the results, such as drug oralcohol dependence or psychiatric disease. Known hypersensitivity to bosentan or any of the excipients. |
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E.5 End points |
E.5.1 | Primary end point(s) |
No primary endpoint is considered for this OL extension study. |
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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 | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
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 |
|
E.8.7 | Trial has a data monitoring committee | No |
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
|
L`evento che si manifesta prima tra: (i) approvazione del bosentan in questa indicazione ottenuta nel paese del paziente o (ii) decisione da parte dello Sponsor di interrompere lo studio AC-052-322 / BUILD 3-OL. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |