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Clinical trials for Nitrogen 13

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   44338   clinical trials with a EudraCT protocol, of which   7368   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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    28 result(s) found for: Nitrogen 13. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2018-004842-40 Sponsor Protocol Number: K020-218 Start Date*: 2019-08-21
    Sponsor Name:Kaleido Biosciences
    Full Title: A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of KB195 in Subjects with a Urea Cycle Disorder with Inadequate Control on Standard of Care
    Medical condition: Subjects with a Urea Cycle Disorder with Inadequate Control on Standard of Care
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10080020 Urea cycle disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) ES (Prematurely Ended) FR (Prematurely Ended) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2015-000982-30 Sponsor Protocol Number: 4993/15 Start Date*: 2016-08-08
    Sponsor Name:FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    Full Title: Personalized pharmacological treatment of chronic obstructive pulmonary disease based on phenotyping: interventional study
    Medical condition: Chronic obstructive pulmonary disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004855 10070975 Chronic obstructive bronchopneumopathy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-002436-82 Sponsor Protocol Number: EC11-441 Start Date*: 2012-12-13
    Sponsor Name:Isabel Pinilla Lozano
    Full Title: Melatonin effects on visual and sleep patterns anomalies in subjects diagnosed with Retinitis Pigmentosa
    Medical condition: To evaluate the sleep quality in patients with Retinitis Pigmentosa
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-001401-41 Sponsor Protocol Number: TAPAS-2014 Start Date*: 2014-07-29
    Sponsor Name:
    Full Title: Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis
    Medical condition: Cystic Fibrosis and chronic infection with Pseudomonas aeruginosa
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Ongoing) IT (Completed)
    Trial results: (No results available)
    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: 2008-001241-26 Sponsor Protocol Number: 971 Start Date*: 2008-09-18
    Sponsor Name:Biotest AG
    Full Title: A randomized, placebo-controlled, double-blind, dose escalation study to evaluate the efficacy, safety and tolerability of the study drug BT971 in patients with rheumatoid arthritis receiving conco...
    Medical condition: Active rheumatoid arthritis, functional class II-III
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039073 Rheumatoid arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2010-021860-13 Sponsor Protocol Number: BIA-91067-301 Start Date*: 2010-11-11
    Sponsor Name:BIAL - Portela & Ca, S.A.
    Full Title: EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH “WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMIS...
    Medical condition: Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10061536 Parkinson's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) LT (Completed) AT (Completed) LV (Completed) DE (Completed) ES (Completed) PT (Completed) CZ (Completed) SK (Completed) BG (Completed) RO (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-004128-22 Sponsor Protocol Number: NP22002 Start Date*: 2009-04-08
    Sponsor Name:F.Hoffmann-La Roche Ltd
    Full Title: An exploratory study to evaluate the biological activity of R1507, a human monoclonal antibody, antagonist of the insulin-like growth factor receptor (IGF-1R) in women with operable breast cancer
    Medical condition: Female patients with operable breast cancer, fulfilling the following criteria.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10006204 Breast carcinoma LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-012337-29 Sponsor Protocol Number: IILFLE09 Start Date*: 2009-07-20
    Sponsor Name:FONDAZIONE ITALIANA LINFOMI ONLUS
    Full Title: Brief induction chemoimmunotherapy with Rituximab + Bendamustine + Mitoxantrone followed by Rituximab in elderly patients with advanced stage previously untreated follicular lymphoma
    Medical condition: Elderly patients with advanced stage previously untreated follicular lymphoma
    Disease: Version SOC Term Classification Code Term Level
    14.1 10005329 - Blood and lymphatic system disorders 10016903 Follicle centre lymphomas, follicular grade I, II, III HLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-021955-14 Sponsor Protocol Number: BUP3030 Start Date*: 2011-10-17
    Sponsor Name:Purdue Pharma L.P.
    Full Title: A Multicenter, Inpatient, Open-label Study to Characterize the Pharmacokinetics, Safety, and Efficacy of Intravenous Dosing of Buprenorphine in Pediatric Patients Aged from Birth to 6 Years of Age...
    Medical condition: Acute moderate to severe pain requiring opioids for at least 24 hours in postoperative and prolonged endotracheal intubated patients
    Disease: Version SOC Term Classification Code Term Level
    14.0 10042613 - Surgical and medical procedures 10002182 Analgesia LLT
    14.0 10042613 - Surgical and medical procedures 10021415 Immediate postoperative analgesia LLT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: HU (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-002059-40 Sponsor Protocol Number: ECT-LANS-IL2 Start Date*: 2012-06-28
    Sponsor Name:ISTITUTO NAZIONALE PER LA CURA TUMORI
    Full Title: Potentiating clinical and immunological effects of chemotherapy by neutralizing acidic pH at tumor site: a phase II randomized study in melanoma patients
    Medical condition: Metastatic Cutaneous and Subcutaneous Melanoma
    Disease: Version SOC Term Classification Code Term Level
    15.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027481 Metastatic melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-002181-32 Sponsor Protocol Number: RG012-03 Start Date*: 2016-12-07
    Sponsor Name:Regulus Therapeutics Inc.
    Full Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, Dose Selection, and Preliminary Efficacy of Weekly RG 012 Injections in Pat...
    Medical condition: Alport syndrome is an inherited form of kidney disease caused by mutations in genes coding for the capillary basement membrane collagen IV
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-000075-27 Sponsor Protocol Number: HPN-100-021 Start Date*: 2016-03-07
    Sponsor Name:Horizon Therapeutics, LLC
    Full Title: A Randomised, Controlled, Open-Label Parallel Arm Study of the Safety, Pharmacokinetics and Ammonia Control of RAVICTI® (Glycerol Phenylbutyrate [GPB]) Oral Liquid and Sodium Phenylbutyrate (NaPBA)...
    Medical condition: Urea Cycle Disorders (UCDs)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000161833 10013373 Disorders of urea cycle metabolism LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) AT (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2020-001724-34 Sponsor Protocol Number: PS0020 Start Date*: 2021-03-02
    Sponsor Name:UCB Biopharma SRL
    Full Title: A Multicenter, Open-Label, Randomized Study to Assess the Pharmacokinetics, Safety, and Efficacy of Two Doses of Bimekizumab in Adolescent Study Participants With Moderate to Severe Plaque Psoriasis
    Medical condition: Moderate to Severe Plaque Psoriasis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10071117 Plaque psoriasis LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA DE (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2008-005867-33 Sponsor Protocol Number: 13701 Start Date*: 2009-03-10
    Sponsor Name:Bayer HealthCare AG
    Full Title: Prospective non-randomized (pharmacoepidemiologic) cohort study (open-label, multicenter) to assess the magnitude of potential risk with the administration of Primovist/Eovist in patients with mode...
    Medical condition: Patients with moderate (eGFR 30 – 59 mL/min/1.73 m2) to severe renal impairment (eGFR < 30 mL/min/1.73 m2) scheduled to undergo contrast-enhanced MRI with Primovist/Eovist.
    Disease: Version SOC Term Classification Code Term Level
    15.1 100000004857 10038469 Renal impairment NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-000528-42 Sponsor Protocol Number: 0601 Start Date*: 2008-07-17
    Sponsor Name:Poniard Pharmaceuticals, Inc.
    Full Title: A Randomized, Controlled Phase III Trial of Picoplatin and Best Supportive Care (BSC) versus BSC Alone in Patients with Small Cell Lung Cancer (SCLC), Refractory or Progressive within Six Months of...
    Medical condition: Small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    9.1 10041071 Small cell lung cancer stage unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) LV (Completed) HU (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-000607-17 Sponsor Protocol Number: SG030-0003 Start Date*: 2004-09-30
    Sponsor Name:Seattle Genetics, Inc.
    Full Title: A Phase II Multi-Dose Study of SGN-30 (anti-CD30 mAb) in Patients with Refractory or Recurrent Hodgkin’s Disease or Anaplastic Large Cell Lymphoma
    Medical condition: Refractory or Recurrent Hodgkin’s Disease or Anaplastic Large Cell Lymphoma MedDRA version 6.0 PT=Hodgkin's Disease NOS recurrent=10020256 PT=Hodgkin's Disease NOS refractory=10020257 PT=Anaplast...
    Disease: Version SOC Term Classification Code Term Level
    6.0 10020256 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DK (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-004128-35 Sponsor Protocol Number: CAEB071A2207 Start Date*: 2007-03-06
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A 12-month open-label, randomized, multicenter, sequential cohort, dose finding study to evaluate the efficacy, safety and tolerability of oral AEB071 versus tacrolimus® in combination with myforti...
    Medical condition: Evaluation of the efficacy and safety of AEB071 in de novo CNI free regimen for prevention of rejection in solid organ transplantation. Combination of AEB071 with a well established, effective ad...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) DE (Prematurely Ended) GB (Prematurely Ended) BE (Completed) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-005623-27 Sponsor Protocol Number: RM-131-009 Start Date*: 2015-04-08
    Sponsor Name:Rhythm Pharmaceuticals, Inc.
    Full Title: A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of RM-131 Administered to Patients with Vomiting Symptoms and Moderate to Severe Diabetic Gastropa...
    Medical condition: Vomiting symptoms in patient with moderate to severe diabetic gastroparesis
    Disease: Version SOC Term Classification Code Term Level
    17.1 10017947 - Gastrointestinal disorders 10051153 Diabetic gastroparesis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) GB (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2006-003169-15 Sponsor Protocol Number: P04273 Start Date*: 2006-12-14
    Sponsor Name:Schering Plough Research Institute
    Full Title: A Phase 2 study of temozolomide (SCH 52365) in Subjects with Advanced Aerodigestive Tract Cancers Selected for Methylation of O6-Methyl-guanine-DNA Methyltransferase (MGMT) Promoter
    Medical condition: Advanced Aerodigestive Tract Cancers (Colorectal Cancer (CRC), Non Small Cell Lung Cancer (NSCLC), Head and Neck (H&N), Esophageal Cancer
    Disease: Version SOC Term Classification Code Term Level
    8.1 10028980 Neoplasm LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) PT (Prematurely Ended) SE (Prematurely Ended) GR (Completed) NL (Prematurely Ended) IT (Completed) GB (Prematurely Ended) ES (Prematurely Ended)
    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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