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Clinical trials for Mitochondrial toxicity

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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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   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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    14 result(s) found for: Mitochondrial toxicity. Displaying page 1 of 1.
    EudraCT Number: 2015-000508-24 Sponsor Protocol Number: 7406 Start Date*: 2015-06-12
    Sponsor Name:Newcastle Upon Tyne Hospitals NHS Trust
    Full Title: A Feasibility Study of Bezafibrate in Mitochondrial Myopathy
    Medical condition: Mitochondrial myopathy due to mt.3243A>G mutation
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10027710 Mitochondrial myopathy PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-003124-16 Sponsor Protocol Number: KH176-204 Start Date*: 2021-01-12
    Sponsor Name:Khondrion B.V.
    Full Title: A randomized placebo controlled, double-blind phase II study to explore the safety, efficacy and pharmacokinetics of sonlicromanol in children with genetically confirmed mitochondrial disease.
    Medical condition: Genetically confirmed mitochondrial disease
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2010-023192-26 Sponsor Protocol Number: MVC-001-MiTox Start Date*: 2011-04-20
    Sponsor Name:mib Dienstleistungsgesellschaft mbH
    Full Title: EFFECT OF SWITCHING FROM NRTIS TO MARAVIROC ON NRTI-ASSOCIATED MITCHONDRIAL TOXICITY AND IMMUNE ACTIVATION
    Medical condition: Increases in inflammatory biomarkers have been associated with various non-AIDS complications such as cardiovascular events. Maraviroc has no known toxic effects on mitochondria and has been shown ...
    Disease: Version SOC Term Classification Code Term Level
    13.1 10027433 - Metabolism and nutrition disorders 10053961 Mitochondrial toxicity PT
    13.1 10021881 - Infections and infestations 10008919 Chronic HIV infection LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-000832-23 Sponsor Protocol Number: KH176-203 Start Date*: 2021-07-12
    Sponsor Name:Khondrion B.V.
    Full Title: A Phase IIb open-label, multi-centre, extension study to explore the long-term safety and efficacy of KH176 in subjects with a genetically confirmed mitochondrial DNA tRNALeu(UUR) m.3243A>G mutatio...
    Medical condition: A genetically confirmed mitochondrial desoxyribonucleic acid (DNA) tRNALeu(UUR) m.3243A>G mutation (including but not limited to MELAS. MIDD and mixed phenotypes.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2019-000599-40 Sponsor Protocol Number: KH176-202 Start Date*: 2019-10-23
    Sponsor Name:Khondrion B.V.
    Full Title: A Phase IIb double-blind, randomised, placebo-controlled, multi-centre, confirmative three-way cross-over study on cognitive function with two doses of KH176 in subjects with a genetically confirme...
    Medical condition: A genetically confirmed mitochondrial desoxyribonucleic acid (DNA) transfer ribonucleic acid (tRNA)Leu(UUR) m.3243A>G mutation (including but not limited to MELAS, MIDD and mixed compositions).
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) GB (GB - no longer in EU/EEA) DE (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2017-003296-60 Sponsor Protocol Number: Oxidise Start Date*: 2018-04-09
    Sponsor Name:University Hospital Tuebingen
    Full Title: Empagliflozin effect on glucose toxicity in type 2 diabetes patients - a randomized, open-label, controlled, parallel group, exploratory study
    Medical condition: Patients with T2DM aged 40 to 70 years (including)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-001476-37 Sponsor Protocol Number: PENTA17 Start Date*: 2015-12-16
    Sponsor Name:Fondazione PENTA ONLUS
    Full Title: SMILE: Strategy for Maintenance of HIV suppression with elvitegravir+darunavir/ritonavir in children (PENTA 17) - A two-arm, Phase 2/3 multicentre, open-label, randomised study evaluating safety ...
    Medical condition: Paediatric HIV-1 Infection
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10068341 HIV-1 infection LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) PT (Completed) GB (GB - no longer in EU/EEA) BE (Completed) DE (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2006-006042-33 Sponsor Protocol Number: KAMON2 Start Date*: 2007-02-01
    Sponsor Name:OSPEDALE S. RAFFAELE
    Full Title: A pilot, open label, multicenter, randomized clinical trial on Lopinavir/Ritonavir-monotherapy vs Lopinavir/Ritonavir plus selected Nucs, in HIV/HCV coinfected patients with chronic hepatitis C or...
    Medical condition: patients affected by HIV and chronic HCV or compensated cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    6.1 10000807 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-005996-17 Sponsor Protocol Number: KAMON1 Start Date*: 2007-02-02
    Sponsor Name:OSPEDALE S. RAFFAELE
    Full Title: A pilot, open label, multicenter, randomized clinical trial on Lopinavir/ritonavir-monotherapy vs Lopinavir/ritonavir plus selected Nucs, in HIV/HCV ARV-naive coinfected patients with chronic hepat...
    Medical condition: PATIENTS AFFECTED BY HIV/HCV NAIVES FROM THERAPIES
    Disease: Version SOC Term Classification Code Term Level
    6.1 10000807 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-001062-41 Sponsor Protocol Number: 13-005 Start Date*: 2013-06-12
    Sponsor Name:RWTH Aachen University, represented by the Rector, himself represented by Clinical Trial Center (CTC-A) [...]
    1. RWTH Aachen University, represented by the Rector, himself represented by Clinical Trial Center (CTC-A)
    2. RWTH Aachen University, represented by the Rector, himself represented by Clinical Trial Center (CTC-A)
    3. RWTH Aachen University, represented by the Rector, himself represented by Clinical Trial Center (CTC-A)
    Full Title: Neoadjuvant chemotherapy with Cabazitaxel in high risk prostate cancer patients prior to radical prostatectomy
    Medical condition: high-risk prostata cancer patients
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-002303-14 Sponsor Protocol Number: A5951110 Start Date*: 2008-12-17
    Sponsor Name:Pfizer Inc. 235 East 42nd Street, New York, NY10017, USA
    Full Title: PROSPECTIVE STUDY OF OPHTHALMOLOGIC FUNCTION IN PATIENTS RECEIVING LINEZOLID FOR TWO MONTHS OR GREATER
    Medical condition: This study is designed to understand the effects of linezolid on the optic nerve by observing and following patients who have been treated with linezolid for two months or longer for the developmen...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10015919 - Eye disorders 10061323 Optic neuropathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-000246-21 Sponsor Protocol Number: PP100-001 Start Date*: 2017-04-25
    Sponsor Name:PledPharma AB
    Full Title: A Randomised Open Label Exploratory, Safety and Tolerability Study with PP100-01 in Patients Treated with the 12-hour Regimen of N-Acetylcysteine for Paracetamol/Acetaminophen Overdose
    Medical condition: The objective of this study is to develop a therapeutic regimen for paracetamol/acetaminophen overdose (POD) where a novel NAC 12hr regime is combined with a superoxide dismutase (SOD) mimetic, PP1...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10022117 - Injury, poisoning and procedural complications 10033295 Overdose PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2008-002383-34 Sponsor Protocol Number: TMC114HIV3017 Start Date*: 2008-10-09
    Sponsor Name:JANSSEN-CILAG
    Full Title: A randomised, controlled, open-label trial to compare brachial artery reactivity and cardiovascular risk of a treatment simplification by darunavir/ritonavir (DRV/r) 800/100 mg O.D. versus a triple...
    Medical condition: HIV-1 Infection
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020161 HIV infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2004-000816-24 Sponsor Protocol Number: FRAN-03-001 Start Date*: 2004-10-28
    Sponsor Name:Abbott France
    Full Title: A Pilot, Open-Label, Randomized, Comparative Study of the Antiviral Efficacy of Lopinavir/Ritonavir Single-Drug Regimen versus Lopinavir/Ritonavir in Combination with Lamivudine/Zidovudine in Antir...
    Medical condition: HIV-1 Infection
    Disease: Version SOC Term Classification Code Term Level
    7.0 10020192 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (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
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