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Clinical trials for LSm

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   44334   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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    17 result(s) found for: LSm. Displaying page 1 of 1.
    EudraCT Number: 2020-001046-19 Sponsor Protocol Number: ORA-D-N01B Start Date*: 2020-08-13
    Sponsor Name:Oramed Ltd.
    Full Title: An Open-Label Multi-Center Study to Assess the Safety and Potential of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients with Nonalcoholic Steatohepatitis (NASH)
    Medical condition: Type 2 Diabetes Patients with Nonalcoholic Steatohepatitis (NASH)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-001249-37 Sponsor Protocol Number: 73763989HPB2004 Start Date*: 2020-12-17
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo‑controlled Study with Deferred Active Treatment to Investigate the Efficacy, Safety, and Pharmacokinetics of JNJ-73763989 + Nucleos(t)ide A...
    Medical condition: Hepatitis B and Hepatitis D Viral Co-infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10057212 Hepatitis viral infections HLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) GB (GB - no longer in EU/EEA) DE (Completed) SE (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-001325-96 Sponsor Protocol Number: PSO-HEP-2007-01 Start Date*: 2007-09-04
    Sponsor Name:Pilar Samper Ots
    Full Title: Estudio de dos pautas de hierro intravenoso para la optimización del tratamiento con epoetina recombinante humana en pacientes con anemia inducida por la radio quimioterapia
    Medical condition: Anemia en pacientes adultos con tumores sólidos tratados con radio-quimioterapia.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-001634-10 Sponsor Protocol Number: SARO.21.001 Start Date*: 2023-01-23
    Sponsor Name:Zydus Therapeutics Inc.
    Full Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium in Subjects with Primary Biliary Cholangitis.
    Medical condition: Primary biliary Cholangitis
    Disease: Version SOC Term Classification Code Term Level
    21.0 10019805 - Hepatobiliary disorders 10080429 Primary biliary cholangitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) IS (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-019884-12 Sponsor Protocol Number: INFIRE-001 Start Date*: 2010-12-17
    Sponsor Name:Universitätsklinikum Aachen
    Full Title: Induction of Fibrosis Regression regarding Chronic Hepatitis B Infection
    Medical condition: Patients with chronic hepatitis B infection and a relevant grade of fibrosis (histological >= F2)
    Disease: Version SOC Term Classification Code Term Level
    15.0 10021881 - Infections and infestations 10008910 Chronic hepatitis B LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2022-000875-37 Sponsor Protocol Number: VanC-IT Start Date*: 2022-11-03
    Sponsor Name:UNIVERSITÀ DEGLI STUDI MILANO BICOCCA
    Full Title: A Prospective, Randomized, Placebo-controlled Clinical Trial of oral vancomycin in adults and young adults (15-17 years old) affected by Primary Sclerosing Cholangitis with or without Inflammatory ...
    Medical condition: Primary Sclerosing Cholangitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004871 10036732 Primary sclerosing cholangitis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-001156-55 Sponsor Protocol Number: C1171002 Start Date*: 2017-11-24
    Sponsor Name:Pfizer Inc. 235 East 42nd Street, New York, NY 10017
    Full Title: A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Study To Evaluate Safety, Tolerability, And Pharmacodynamics Of PF-05221304 Administered Daily For 16-Weeks To...
    Medical condition: Nonalcoholic Fatty Liver Disease (NAFLD)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10019805 - Hepatobiliary disorders 10053219 Non-alcoholic steatohepatitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: View results
    EudraCT Number: 2021-006069-39 Sponsor Protocol Number: LPS16141 Start Date*: 2022-06-26
    Sponsor Name:Sanofi-Aventis Recherche & Développement
    Full Title: A Randomized, Double-Blind, Parallel-Group Clinical Trial to Assess the Efficacy of Essentiale on Hepatic Steatosis Added to Standard of Care Versus Placebo Added to Standard of Care, in Non-Alcoho...
    Medical condition: Non-alcoholic fatty liver disease associated with type 2 diabetes mellitus and/or hyperlipidemia and/or obesity
    Disease: Version SOC Term Classification Code Term Level
    25.0 100000004871 10082249 Nonalcoholic fatty liver disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-004794-10 Sponsor Protocol Number: A3841047 Start Date*: 2006-12-14
    Sponsor Name:Pfizer Limited
    Full Title: A CLUSTER RANDOMIZED TRIAL ON CARDIOVASCULAR RISK FACTOR MANAGEMENT: CADUET® VERSUS USUAL CARE IN SUBJECTS WITH HYPERTENSION AND ADDITIONAL CARDIOVASCULAR RISK FACTORS IN CLINICAL PRACTICE
    Medical condition: HYPERTENSION AND ADDITIONAL CARDIOVASCULAR RISK FACTORS.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10020772 Hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2022-002538-14 Sponsor Protocol Number: 218672 Start Date*: 2023-06-12
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: 17-beta-Hydroxysteroid Dehydrogenase type 13 Minimization for the treatment of NASH (HORIZON): A Double-Blind, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of GSK4532990 in...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    24.1 10019805 - Hepatobiliary disorders 10053219 Non-alcoholic steatohepatitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Trial now transitioned) BE (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-001428-33 Sponsor Protocol Number: PLN-74809-PSC-203 Start Date*: 2020-11-05
    Sponsor Name:Pliant Therapeutics, Inc
    Full Title: A randomized, double-blind, dose-ranging, placebo-controlled, Phase 2a evaluation of the safety, tolerability, and pharmacokinetics of PLN-74809 in participants with primary sclerosing cholangitis ...
    Medical condition: Primary sclerosing cholangitis (PSC)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004871 10036732 Primary sclerosing cholangitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) AT (Completed) DE (Completed) BE (Completed) FR (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2018-004431-79 Sponsor Protocol Number: CC-90001-NASH-001 Start Date*: 2019-11-15
    Sponsor Name:Celgene Corporation
    Full Title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, DOSEFINDING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-90001 IN SUBJECTS WITH NONALCOHOLIC STEATOHEPATITIS (NASH) AND LIVE...
    Medical condition: Confirmed diagnosis of NASH and Stage 3 or Stage 4 fibrosis based upon the NASH Clinical Research Network (CRN) Histologic Scoring System and a nonalcoholic fatty liver disease (NAFLD) Activity Sco...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Prematurely Ended) ES (Ongoing) PL (Completed)
    Trial results: View results
    EudraCT Number: 2011-001326-26 Sponsor Protocol Number: NI-0801-03 Start Date*: 2011-05-27
    Sponsor Name:NovImmune S.A.
    Full Title: PIANO. Primary Biliary Cirrhosis: Investigating A New Treatment Option using NI-0801, a fully human anti-CXCL10 monoclonal antibody. An open label single arm study to investigate the safety and eff...
    Medical condition: Primary biliary cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10019805 - Hepatobiliary disorders 10036680 Primary biliary cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2022-002695-37 Sponsor Protocol Number: CLIN-60190-453 Start Date*: 2023-04-27
    Sponsor Name:Ipsen Bioscience, Inc.
    Full Title: A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open-Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants with Primary ...
    Medical condition: Adults patients with Primary Sclerosing Cholangitis (PSC)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10019805 - Hepatobiliary disorders 10036732 Primary sclerosing cholangitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) ES (Ongoing) PT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-005057-87 Sponsor Protocol Number: 337HNAS21016 Start Date*: 2022-06-15
    Sponsor Name:Inventiva S.A.
    Full Title: A placebo-controlled, proof-of-concept study to evaluate the safety and efficacy of Lanifibranor alone and in combination with the sodium-glucose transport protein 2 (SGLT2) inhibitor EmpaGliflozin...
    Medical condition: Type 2 Diabetes (T2DM) with Non-Alcoholic Steatohepatitis (NASH)
    Disease: Version SOC Term Classification Code Term Level
    24.1 10019805 - Hepatobiliary disorders 10053219 Non-alcoholic steatohepatitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) BE (Completed) NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-002341-38 Sponsor Protocol Number: 282-CC-207 Start Date*: 2020-07-02
    Sponsor Name:NGM Biopharmaceuticals, Inc.
    Full Title: Evaluation of Efficacy, Safety and Tolerability of NGM282 (Aldafermin) in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Subjects with Compensated Cirrhosis Due to ...
    Medical condition: Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
    Disease: Version SOC Term Classification Code Term Level
    22.0 10019805 - Hepatobiliary disorders 10053219 Non-alcoholic steatohepatitis PT
    20.1 10019805 - Hepatobiliary disorders 10064844 Compensated cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) FR (Completed) BE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2018-001795-38 Sponsor Protocol Number: ALLTogether1 Start Date*: 2020-05-15
    Sponsor Name:Karolinska University Hospital
    Full Title: ALLTogether1– A Treatment study protocol of the ALLTogether Consortium for children and young adults (0-45 years of age) with newly diagnosed acute lymphoblastic leukaemia (ALL)
    Medical condition: Acute lymphoblastic leukaemia (ALL)
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000844 Acute lymphoblastic leukaemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) FI (Trial now transitioned) SE (Trial now transitioned) DK (Trial now transitioned) IE (Trial now transitioned) GB (GB - no longer in EU/EEA) BE (Trial now transitioned) PT (Trial now transitioned) LT (Trial now transitioned) NO (Trial now transitioned) NL (Trial now transitioned) FR (Trial now transitioned) IS (Trial now transitioned)
    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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