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210507s2023 xx |||||o 00| ||eng c |
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|a (DE-627)CTG005788269
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|a (UBBS_Klinische_Studien_WHO)EUCTR2019-003051-11-DK
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|a (UBBS_Klinische_Studien_WHO)AA1817
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|a This trial will evaluate the safety and efficacy of HepaStem compared to placebo in patients with a cirrhotic liver condition called Acute on Chronic Liver Failure (ACLF). The study will be performed in multiple centers and in a double-blinded manner, meaning neither the patients nor the treating physicians know who is on placebo or the study drug.
|b Randomized, placebo-controlled, double blind, multi-centre Phase IIb study to evaluate the efficacy and safety of HepaStem in patients with Acute on Chronic Liver Failure (ACLF) - DHELIVER - HEP102 - DHELIVER
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|c 2023
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|a WHO International Clinical Trials Registry Platform (https://www.who.int/ictrp/en/), First posted: 19-12-2019, Last updated: 2023-06-29
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|a Medical Condition: in phase 1b part: advanced and/or treatment refractory solid malignancies in phase 2 part : advanced or metastatic HER2-negative breast cancer MedDRA version: 20.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1Level: PTClassification code 10070308Term: Refractory cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0Level: LLTClassification code 10048683Term: Advanced cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps);Therapeutic area: Diseases [C] - Cancer [C04]
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|a Study Type: Interventional
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|a Phase: Phase 1
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|a Recruitment Status: Authorised-recruitment may be ongoing or finished
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|a 610
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|g (2023) vom: 21. Juni
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|g year:2023
|g day:21
|g month:06
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