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Clinical trials for AEterna

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    10 result(s) found for: AEterna. Displaying page 1 of 1.
    EudraCT Number: 2012-005546-38 Sponsor Protocol Number: AEZS-108-050 Start Date*: 2013-10-14
    Sponsor Name:Aeterna Zentaris GmbH
    Full Title: Randomised controlled study comparing AEZS-108 with doxorubicin as second line therapy for locally advanced, recurrent or metastatic endometrial cancer
    Medical condition: Endometrial cancer, advanced, recurrent or metastatic
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10014741 Endometrial cancer stage IV PT
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10014740 Endometrial cancer stage III PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: CZ (Completed) BE (Completed) GB (Completed) AT (Completed) DE (Completed) ES (Completed) IE (Completed) IT (Completed) BG (Completed) NL (Completed) PL (Completed) DK (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2015-002337-22 Sponsor Protocol Number: AEZS-130-052 Start Date*: 2015-12-08
    Sponsor Name:Aeterna Zentaris GmbH
    Full Title: 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 ...
    Medical condition: Diagnosis of Adult Growth Hormone Deficiency (AGHD)
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) AT (Completed) DE (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-001988-23 Sponsor Protocol Number: AEZS-130-P01 Start Date*: 2018-11-07
    Sponsor Name:Aeterna Zentaris GmbH
    Full Title: Open label, group comparison, dose escalation trial to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of macimorelin acetate after single oral dosing of 0.25 mg/kg, 0.5 mg/...
    Medical condition: Diagnosis of Growth Hormone Deficiency
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004848 10073227 Growth hormone stimulation test LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2007-002598-30 Sponsor Protocol Number: AEZS-102-036 Start Date*: 2008-02-08
    Sponsor Name:Aeterna Zentaris GmbH
    Full Title: Cetrorelix pamoate in patients with symptomatic BPH: a double-blind placebo-controlled efficacy study
    Medical condition: Benign Prostatic Hyperplasia (PBH)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10004446 Benign prostatic hyperplasia LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: NL (Prematurely Ended) GB (Prematurely Ended) DE (Prematurely Ended) CZ (Prematurely Ended) FR (Completed) BG (Prematurely Ended) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-001989-42 Sponsor Protocol Number: AEZS-130-P02 Start Date*: 2022-05-05
    Sponsor Name:Aeterna Zentaris GmbH
    Full Title: Multicenter, open label trial to investigate the efficacy and safety of a single oral dose of 1.0 mg/kg macimorelin acetate as growth hormone stimulation test (GHST) in pediatric patients with susp...
    Medical condition: Diagnosis of growth hormone deficiency in pediatric subjects
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SI (Completed) DE (Ongoing) PL (Ongoing) IT (Ongoing) SK (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-000134-19 Sponsor Protocol Number: AEZS-108-049 Start Date*: 2012-09-07
    Sponsor Name:Aeterna Zentaris GmbH
    Full Title: A randomised, phase 2 trial of AEZS-108 in chemotherapy refractory triple negative (ER/PR/HER2-negative) LHRH-R positive metastatic breast cancer
    Medical condition: Histologically confirmed malignancy of breast tissue; estrogen- and progesterone receptor negative, non overexpressing HER2-receptors, LHRH receptor positive tumor status; receptor status determine...
    Disease: Version SOC Term Classification Code Term Level
    15.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10057654 Breast cancer female PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-004865-17 Sponsor Protocol Number: AEZS-102-041 Start Date*: 2008-08-15
    Sponsor Name:Aeterna Zentaris GmbH
    Full Title: Cetrorelix pamoate (AEZS-102) in patients with symptomatic BPH: an open-labeled safety and efficacy assessment study
    Medical condition: Benign Prostatic Hyperplasia (BPH)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10004446 Benign prostatic hyperplasia LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: BG (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-003414-34 Sponsor Protocol Number: D-20762-Z033 Start Date*: 2007-11-12
    Sponsor Name:Aeterna Zentaris GmbH
    Full Title: Cetrorelix pamoate intermittent IM dosage regimens in patients with symptomatic BPH: a 1year placebo-controlled efficacy study and long-term safety assessment
    Medical condition: Benign Prostatic Hyperplasia (PBH)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10004446 Benign prostatic hyperplasia LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Prematurely Ended) BG (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2010-018893-19 Sponsor Protocol Number: 339 Start Date*: 2011-03-25
    Sponsor Name:Aeterna Zentaris GmbH
    Full Title: A Phase III Randomized Study to Assess the Efficacy and Safety of Perifosine Added to the Combination of Bortezomib and Dexamethasone in Multiple Myeloma Patients Previously Treated with Bortezomib
    Medical condition: Multiple Myeloma
    Disease: Version SOC Term Classification Code Term Level
    15.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028228 Multiple myeloma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) SK (Prematurely Ended) ES (Prematurely Ended) IE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-002663-26 Sponsor Protocol Number: AEZS-108-040 Start Date*: 2007-12-05
    Sponsor Name:AEterna Zentaris GmbH
    Full Title: Antitumoral activity and safety of AEZS-108 (AN-152), a LHRH agonist linked doxorubicin, in women with LHRH receptor positive gynecological tumors
    Medical condition: Histologically confirmed malignancy of ovary or endometrium that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective and LHR...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10007069 Cancer of endometrium stage III LLT
    9.1 10007065 Cancer of endometrium recurrent LLT
    9.1 10007070 Cancer of endometrium stage IV LLT
    9.1 10057529 Ovarian cancer metastatic LLT
    9.1 10066697 Ovarian cancer recurrent PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Completed) BG (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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