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Clinical trials for Animal Efficacy Rule

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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    10 result(s) found for: Animal Efficacy Rule. Displaying page 1 of 1.
    EudraCT Number: 2017-003190-34 Sponsor Protocol Number: ACE-536-MDS-002 Start Date*: 2019-01-02
    Sponsor Name:Celgene Corporation
    Full Title: A Phase 3, Open -label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Ris...
    Medical condition: Myelodysplastic syndrome (MDS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10068361 MDS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Trial now transitioned) LT (Trial now transitioned) FR (Trial now transitioned) PT (Trial now transitioned) ES (Ongoing) NL (Trial now transitioned) BE (Trial now transitioned) PL (Trial now transitioned) AT (Trial now transitioned) IT (Trial now transitioned) GR (Trial now transitioned) HU (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2004-004743-22 Sponsor Protocol Number: FFR30006 Start Date*: Information not available in EudraCT
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mc...
    Medical condition: Vasomotor/Idiopathic Rhinitis
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed) CZ (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2004-004744-43 Sponsor Protocol Number: FFR30007 Start Date*: Information not available in EudraCT
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mc...
    Medical condition: Vasomotor/Idiopathic Rhinitis
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed) CZ (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-004888-37 Sponsor Protocol Number: FFR111158 Start Date*: 2016-08-03
    Sponsor Name:GlaxoSmithKline Research and Development Ltd
    Full Title: A Pilot, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multicentre Study to Evaluate the Efficacy and Safety of Once-daily Intranasal Administration of Fluticasone Furoate Nasal Spr...
    Medical condition: Irritant (non-allergic) rhinitis
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-003020-32 Sponsor Protocol Number: A011-16 Start Date*: 2022-02-03
    Sponsor Name:Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ, USA
    Full Title: Phase 2, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of Sotatercept versus Placebo-Controlled for the Treatment of Combined Postcapillary and Precapillary Pulmonary ...
    Medical condition: Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) due to Heart Failure with Preserved Ejection Fraction (HFpEF)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10037400 Pulmonary hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) FR (Trial now transitioned) DE (Trial now transitioned) ES (Ongoing) IT (Trial now transitioned) SE (Trial now transitioned)
    Trial results: View results
    EudraCT Number: 2017-004738-27 Sponsor Protocol Number: A011-09 Start Date*: 2018-08-15
    Sponsor Name:Acceleron Pharma Inc.
    Full Title: A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonar...
    Medical condition: Pulmonary Arterial Hypertension (PAH)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10077739 Pulmonary arterial hypertension WHO functional class I LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2021-000596-37 Sponsor Protocol Number: COMBOLA Start Date*: 2021-10-29
    Sponsor Name:Groupe Francophone des Myélodysplasies
    Full Title: A randomized phase I/ II multicenter study evaluating combination of luspatercept in LR-MDS without RS having failed or being ineligible to ESA
    Medical condition: Low risk myelodysplastic syndrom without RS having failed or being ineligible to Erythroid Stimulating Agent
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10028536 Myelodysplastic syndromes HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-001538-20 Sponsor Protocol Number: QOL-ONEPhoenix Start Date*: 2022-10-19
    Sponsor Name:ASSOCIAZIONE QOL-ONE
    Full Title: Efficacy and Safety of Luspatercept for the Treatment of Anemia Due to Myelodysplastic Syndromes with del5q refractory/resistant/intolerant to Prior Treatments, Who Require Red Blood Cell Transfusion.
    Medical condition: Anemia due to MDS with del5q with IPSS-R very low, low, or intermediate risk MDS and a bone marrow blast count of < 5% , Refractory or intolerant to, or ineligible for, prior ESA treatment and for ...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10028532 Myelodysplasia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-004899-18 Sponsor Protocol Number: LUSPLUS Start Date*: 2021-09-17
    Sponsor Name:GWT-TUD GmbH
    Full Title: A phase IIIb, open-label, single arm study to evaluate the efficacy and safety of luspatercept in patients with lower-risk MDS and ring-sideroblastic phenotype (MDS-RS)
    Medical condition: Lower-risk myelodysplastic syndrome with ring-sideroblastic phenotype (MDS-RS)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028534 Myelodysplastic syndrome NOS LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10068361 MDS LLT
    20.0 10005329 - Blood and lymphatic system disorders 10050910 Bone marrow disorder NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) AT (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003454-41 Sponsor Protocol Number: ACE-536-MDS-001 Start Date*: 2016-05-10
    Sponsor Name:Celgene Corporation
    Full Title: A Phase 3, Double-Blind, Randomized Study To Compare The Efficacy And Safety Of Luspatercept (ACE-536) Versus Placebo For The Treatment Of Anemia Due To IPSS-R Very Low, Low, Or Intermediate Risk M...
    Medical condition: Subjects with ring sideroblasts who require regular Red Blood Cell (RBC) Transfusions due to anemia due to Myelodysplastic Syndromes (MDS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10002272 Anemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) NL (Completed) BE (Completed) SE (Completed) IT (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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