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Clinical trials for Promethera

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
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    • 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   44407   clinical trials with a EudraCT protocol, of which   7416   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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    8 result(s) found for: Promethera. Displaying page 1 of 1.
    EudraCT Number: 2019-003051-11 Sponsor Protocol Number: HEP102-DHELIVER Start Date*: 2019-12-04
    Sponsor Name:Promethera Therapeutics
    Full Title: 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
    Medical condition: Cirrhotic patients who are hospitalized for Acute on chronic liver failure (ACLF), ACLF combines an acute deterioration of liver function in an individual with pre-existing chronic liver disease a...
    Disease: Version SOC Term Classification Code Term Level
    24.0 10019805 - Hepatobiliary disorders 10077305 Acute on chronic liver failure PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Trial now transitioned) BE (Trial now transitioned) DE (Trial now transitioned) LV (Trial now transitioned) LT (Trial now transitioned) SK (Trial now transitioned) GB (GB - no longer in EU/EEA) DK (Trial now transitioned) PL (Trial now transitioned) PT (Completed) EE (Trial now transitioned) AT (Trial now transitioned) ES (Ongoing) NL (Trial now transitioned) SI (Completed) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-003989-27 Sponsor Protocol Number: PROLONGSTEM Start Date*: Information not available in EudraCT
    Sponsor Name:Promethera Therapeutics
    Full Title: PROLONGSTEM: HepaStem Long-Term Safety Registry Registry for patients who have been administered HepaStem
    Medical condition: This study will include all patients having received at least one infusion of the Investigational Medicinal Product (IMP) HepaStem HALPC during a previous interventional clinical study conducted by...
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10021601 Inborn error of metabolism NOS LLT
    20.0 100000004871 10008954 Chronic liver disease and cirrhosis LLT
    20.1 100000004871 10049844 Acute liver failure LLT
    21.1 200000003094 10013373 Disorders of urea cycle metabolism LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) FR (Trial now transitioned) ES (Ongoing) GB (GB - no longer in EU/EEA) BG (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-004074-28 Sponsor Protocol Number: UKHEP001 Start Date*: 2012-07-20
    Sponsor Name:Promethera Biosciences
    Full Title: A prospective, open label, multicenter, randomized, safety and preliminary efficacy study of one cycle of Promethera HepaStem® in Urea Cycle Disorders and Crigler-Najjar Syndrome patients
    Medical condition: Crigler-Najjar syndrome is associated with a complete or partial hepatic deficit of bilirubin glucuronosyltransferase activity and is apparent during the neonatal period by intense jaundice. The ur...
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004850 10021601 Inborn error of metabolism NOS LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-000988-14 Sponsor Protocol Number: CCD05 Start Date*: 2016-10-12
    Sponsor Name:PROMETHERA Biosciences S.A./N.V.
    Full Title: Title: Open, Prospective, Historic-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Infusion of Liver Cell Suspension (HHLivC) in Children with Urea Cycle Disorders
    Medical condition: Neonatal-onset type of the following urea cycle disorders (UCD): ornithine transcarbamylase deficiency (OTCD), carbamoylphosphate synthetase I deficiency (CPS1D), or argininosuccinate synthetas...
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-001177-32 Sponsor Protocol Number: HEP101 Start Date*: 2016-08-09
    Sponsor Name:Promethera Biosciences
    Full Title: Multicenter Phase II Safety and Preliminary Efficacy Study of 2 dose regimens of HepaStem in Patients with Acute on Chronic Liver Failure
    Medical condition: The study will recruit cirrhotic patients who are hospitalized for Acute-on-chronic liver failure (ACLF) or Acute Decompensation at risk of developing ACLF. ACLF combines an acute deterioration of...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004871 10008954 Chronic liver disease and cirrhosis LLT
    20.1 100000004871 10049844 Acute liver failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed) ES (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2013-001045-14 Sponsor Protocol Number: SAF001 Start Date*: 2013-04-22
    Sponsor Name:Promethera Biosciences
    Full Title: SAF 001: A long-term safety follow-up study of patients suffering from Urea Cycle disorders (UCD) or Crigler-Najjar Syndrome (CN) having received infusions of HepaStem.
    Medical condition: Crigler-Najjar syndrome is associated with a complete or partial hepatic deficit of bilirubin glucuronosyltransferase activity and is apparent during the neonatal period by intense jaundice. The ur...
    Disease: Version SOC Term Classification Code Term Level
    15.1 100000004850 10021601 Inborn error of metabolism NOS LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed) PT (Completed) IT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-000650-11 Sponsor Protocol Number: HEP002 Start Date*: 2014-09-15
    Sponsor Name:Promethera Biosciences
    Full Title: A prospective, open label, multicountry, efficacy and safety study of several infusions of HepaStem in Urea Cycle Disorders pediatric patients.
    Medical condition: The urea cycle disorders are inborn errors of metabolism that affect the transfer of nitrogen into urea. There are seven disorders to be investigated: carbamoylphosphate synthetase I deficiency [CP...
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004861 10013373 Disorders of urea cycle metabolism LLT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) ES (Completed) FR (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2018-004449-18 Sponsor Protocol Number: HEP201 Start Date*: 2019-04-10
    Sponsor Name:Promethera Biosciences
    Full Title: Multicenter, open-label, safety and tolerability study of ascending doses of HepaStem in patients with cirrhotic and pre-cirrhotic non-alcoholic steatohepatitis (NASH).
    Medical condition: NASH is characterized by steatosis, inflammation and cytological ballooning with varying amounts of fibrosis. Patients with NASH are at risk of cardiovascular morbidity and mortality. In chronic li...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10019805 - Hepatobiliary disorders 10031743 Other chronic nonalcoholic liver disease LLT
    20.0 10019805 - Hepatobiliary disorders 10019708 Hepatic steatosis PT
    20.0 10019805 - Hepatobiliary disorders 10041970 Steatosis hepatic LLT
    20.0 10019805 - Hepatobiliary disorders 10019669 Hepatic fibrosis and cirrhosis HLT
    20.0 10019805 - Hepatobiliary disorders 10009211 Cirrhosis liver LLT
    20.0 10019805 - Hepatobiliary disorders 10024667 Liver cirrhosis LLT
    20.0 10019805 - Hepatobiliary disorders 10009213 Cirrhosis of liver LLT
    20.1 10019805 - Hepatobiliary disorders 10064704 Decompensated cirrhosis LLT
    20.1 10019805 - Hepatobiliary disorders 10064844 Compensated cirrhosis LLT
    20.1 10019805 - Hepatobiliary disorders 10053219 Non-alcoholic steatohepatitis PT
    20.0 10019805 - Hepatobiliary disorders 10076331 Steatohepatitis PT
    20.0 10019805 - Hepatobiliary disorders 10019641 Hepatic cirrhosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) BE (Completed) BG (Completed) PL (Completed) ES (Ongoing) RO (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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