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Clinical trials for Hydroxy acids

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 ).  
     
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    2 result(s) found for: Hydroxy acids. Displaying page 1 of 1.
    EudraCT Number: 2018-002575-17 Sponsor Protocol Number: 747-213 Start Date*: 2019-07-25
    Sponsor Name:Intercept Pharmaceuticals, Inc.
    Full Title: A Phase 2, Double-Blind, Randomized, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid, Administered Alone or in Combination with Bezafibrate, in Subjects w...
    Medical condition: Primary Biliary Cholangitis (PBC) in patients with Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004871 10036680 Primary biliary cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Trial now transitioned) FR (Trial now transitioned) SE (Completed) ES (Restarted) BE (Trial now transitioned) GB (GB - no longer in EU/EEA) SK (Prematurely Ended) DE (Trial now transitioned) CZ (Trial now transitioned) LT (Trial now transitioned) GR (Trial now transitioned) NL (Trial now transitioned) PL (Completed) AT (Completed) HR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-003392-30 Sponsor Protocol Number: 15-0106 Start Date*: 2016-04-18
    Sponsor Name:NGM Biopharmaceuticals, Inc.
    Full Title: A PHASE 2, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, MULTIPLE CENTER STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF NGM282 ADMINISTERED FOR 12 WEEKS IN PATIENTS WIT...
    Medical condition: PRIMARY SCLEROSING CHOLANGITIS (PSC)
    Disease: Version SOC Term Classification Code Term Level
    19.0 10019805 - Hepatobiliary disorders 10036732 Primary sclerosing cholangitis LLT
    19.0 10019805 - Hepatobiliary disorders 10004607 Bile duct infections and inflammations HLT
    19.0 10019805 - Hepatobiliary disorders 10019805 Hepatobiliary disorders SOC
    19.0 10019805 - Hepatobiliary disorders 10008609 Cholangitis sclerosing PT
    19.0 10019805 - Hepatobiliary disorders 10004606 Bile duct disorders HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) NL (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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