E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049416 |
E.1.2 | Term | <Manually entered code. Term in E.1.1> |
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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 clinical study is to further study long term safety and efficacy in subjects who have completed 24-weeks of dosing in Study CL0600-020: A 24-Week Study of the Efficacy and Safety of Teduglutide in Subjects with Parenteral Nutrition (PN/IV) Dependent Short Bowel Syndrome (SBS).
Long-term safety data and data on PN/IV volume (L/week) will be collected at each study visit. Numbers of subjects who achieve 20, 50, 75 and 100% reduction in PN/IV volume from baseline will be calculated for each visit during this study. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects who meet all of the following criteria can be enrolled in this study: 1. Completion of 24-weeks of dosing in Study CL0600-020 or based on investigator and sponsor decision if the subject was required to stop dosing prematurely due to a non-drug related adverse experience or successful completion of stage I (optimization/stabilization) in Study CL0600-020 (ie., qualification for randomization) after approximately 86 subjects have been randomized.
2. Signed and dated informed consent form (ICF) to participate before any study-related procedures of Study CL0600-021 are performed. |
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E.4 | Principal exclusion criteria |
Exclusion criteria do not apply as only those subjects who have participated in Study CL0600-020 and do not meet the events necessitating withdrawal from the study as listed in Section 4.4.2 of this protocol are eligible. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Data on the PN/IV volume (actual volume, L/week) will be collected at study visits to explore the long-term effects of teduglutide treatement.
Subjects' quality of life (QoL) will be evaluated by using a subject-reported outcome SBS specific QoL scale.
Adverse events, 12-lead ECG, vital signs laboratory safety data, antibodies to teduglutide and/or E.coli protein (ECP), and changes in urine output and body weight will be evaluated. Colonoscopy will be performed at the end of the 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 | No |
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 | Yes |
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 | 20 |
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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Study end is defined as the hard-lock of the database. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |