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Clinical trials for Isozymes

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   44336   clinical trials with a EudraCT protocol, of which   7366   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 ).  
     
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    6 result(s) found for: Isozymes. Displaying page 1 of 1.
    EudraCT Number: 2016-004664-18 Sponsor Protocol Number: NEOD001-OLE251 Start Date*: 2017-08-08
    Sponsor Name:Prothena Therapeutics Limited
    Full Title: A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO)
    Medical condition: The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021428 - Immune system disorders 10036673 Primary amyloidosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended) ES (Prematurely Ended) GR (Completed) AT (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-003865-11 Sponsor Protocol Number: NEOD001-CL002 Start Date*: 2015-11-27
    Sponsor Name:Prothena Therapeutics Limited
    Full Title: A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care vs. Placebo Plus Standard of Care in Subjects with Light Chai...
    Medical condition: Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in bo...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021428 - Immune system disorders 10036673 Primary amyloidosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) AT (Prematurely Ended) ES (Completed) BE (Prematurely Ended) NL (Prematurely Ended) FR (Prematurely Ended) GB (Prematurely Ended) GR (Completed) PL (Prematurely Ended) DK (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-004318-14 Sponsor Protocol Number: NEOD001-201 Start Date*: 2016-06-13
    Sponsor Name:Prothena Therapeutics Limited
    Full Title: A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction
    Medical condition: Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in bo...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021428 - Immune system disorders 10036673 Primary amyloidosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) GB (Completed) GR (Completed) ES (Prematurely Ended) AT (Completed)
    Trial results: View results
    EudraCT Number: 2021-000037-14 Sponsor Protocol Number: NEOD001-301 Start Date*: 2021-09-01
    Sponsor Name:Prothena Biosciences Limited
    Full Title: A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with ...
    Medical condition: AL amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, a...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021428 - Immune system disorders 10036673 Primary amyloidosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned) HU (Trial now transitioned) DE (Trial now transitioned) PT (Trial now transitioned) FR (Trial now transitioned) PL (Trial now transitioned) ES (Ongoing) CZ (Trial now transitioned) GR (Trial now transitioned) NL (Trial now transitioned) IT (Trial now transitioned) IE (Trial now transitioned) BE (Trial now transitioned) AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2006-004507-18 Sponsor Protocol Number: CRAD001C2325 Start Date*: 2007-01-22
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized, double-blind, placebo-controlled, multicenter phase III study in patients with advanced carcinoid tumor receiving Sandostatin LAR® Depot and RAD001 10 mg/d or Sandostatin LAR® Depot a...
    Medical condition: Low grade neuroendocrine carcinoma consists of carcinoid and pancreatic endocrine tumors. These tumors originate from the neuroendocrine cells throughout the body and are capable of producing vario...
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10007276 Carcinoid tumour NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) SE (Completed) FR (Completed) BE (Completed) SK (Completed) DE (Completed) ES (Completed) NL (Completed) GB (Completed) GR (Completed) IT (Completed) FI (Completed) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-000713-32 Sponsor Protocol Number: CAEL101-302 Start Date*: 2021-02-09
    Sponsor Name:Caelum Biosciences, Inc.
    Full Title: A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dysc...
    Medical condition: stage IIIa cardiac AL amyloidosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10007509 Cardiac amyloidosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Trial now transitioned) GB (GB - no longer in EU/EEA) GR (Trial now transitioned) PL (Trial now transitioned) BE (Completed) IT (Trial now transitioned) AT (Trial now transitioned) CZ (Trial now transitioned) NL (Completed)
    Trial results: (No results available)
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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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