Danke Carvin! Das ist Balsam für meine AEterna geschundene Seele. :-)
Auch wenn meine Ausführungen teilweise in die falsche Richtung führen, bin ich doch gewillt zu informieren.
Macrilen.
A. Protocol Information
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| A.1 | Member State Concerned | Germany - BfArM | | A.2 | EudraCT number | 2015-002337-22 | | A.3 | Full title of the trial | Confirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT)
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| | A.3.1 | Title of the trial for lay people, in easily understood, i.e. non-technical, language | | Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adults |
| | A.3.2 | Name or abbreviated title of the trial where available | Validation of macimorelin as a test for Adult Growth Hormone Deficiency
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Sponsor Information
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| B.Sponsor: 1 | | B.1.1 | Name of Sponsor | Aeterna Zentaris GmbH
| | B.1.3.4 | Country | Germany
| | B.3.1 and B.3.2 | Status of the sponsor | Commercial | | B.4 Source(s) of Monetary or Material Support for the clinical trial: | | B.4.1 | Name of organisation providing support | Aeterna Zentaris GmbH | | B.4.2 | Country | Germany | | B.5 Contact point designated by the sponsor for further information on the trial | | B.5.1 | Name of organisation | Aeterna Zentaris GmbH | | B.5.2 | Functional name of contact point | Clinical trial information desk | | B.5.3 | Address: | | B.5.3.1 | Street Address | Weismuellerstraße 50 | | B.5.3.2 | Town/ city | Frankfurt am Main | | B.5.3.3 | Post code | 60314 | | B.5.3.4 | Country | Germany | | B.5.4 | Telephone number | +4969426023472 | | B.5.5 | Fax number | +4969426023404 | | B.5.6 | E-mail | clinical.trials@aezsinc.com
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E.2 Objective of the trial
| | E.2.1 | Main objective of the trial | To validate the use of single dose oral macimorelin for the dagnosis of AGHD ('macimorelin GHST'), using the Insulin Tolerance Test (ITT) as comparator (non-reference standard) GHST.
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| | E.2.2 | Secondary objectives of the trial | To characterize the safety profile of single dose oral macimorelin in suspected AGHD subjects
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E.5 End points
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| Primary end point(s) | Co-Primary efficacy variables will be 'Percent Negative Agreement' and 'Percent Positive Agreement' when using predefined cut-points of both GHSTs.
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| | E.5.1.1 | Timepoint(s) of evaluation of this end point | | Evaluation of the Primary endpoints will be performed at two timepoints (i.e. during two separate visits per Growth Hormone Stimulation Test): For Test 1 on Day 1, for Test 2 on D8-28 (i.e. on one day within a time period from Day8 to Day28) |
| | E.5.2 | Secondary end point(s) | Secondary efficacy criteria will be 'Percent Overall Agreement' and estimated sensitivity and specificity of both GHSTs when using predefined cut-points of both GHSTs.
Safety:
Adverse events, clinical laboratory and 12-lead ECG.
Other:
Test acceptance/Preference by Trial subjects and investigators.
Preliminary PK: Tmax and Cmax of macimorelin Plasma concentrations in the sampling period.
Preliminary PK/PD: Tmax for macimorelin vs Tmax for GH; Cmax for macimorelin vs Cmax for GH. |
| | E.5.2.1 | Timepoint(s) of evaluation of this end point | Evaluation of the secondary endpoints will be:
- efficacy related at two timepoints (i.e. during two separate visits per Growth Hormone Stimulation Test), as mentioned in Section E.5.1.1: For Test 1 on Day 1, for Test 2 on D8-28 (i.e. on one day within a time period from Day8 to Day28)
- safety related at four timepoints, i.e. at all four visits of this Trial (Screening visit, Test 1, Test 2, End-of-Trial visit)
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https://www.clinicaltrialsregister.eu/ctr-search/...2015-002337-22/DE
Sieht so aus, als AEterna Deutschland für Macrilen zuständig ist.
Sehe ich das richtig, das es nicht darum geht besser zu sein als der ITT Test?
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