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Clinical trials for Heparan sulfate

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   44346   clinical trials with a EudraCT protocol, of which   7374   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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    18 result(s) found for: Heparan sulfate. Displaying page 1 of 1.
    EudraCT Number: 2009-015984-15 Sponsor Protocol Number: HGT-SAN-055 Start Date*: 2010-03-25
    Sponsor Name:Shire Human Genetic Therapies, Inc. (Shire HGT)
    Full Title: A Phase I/II Safety, Tolerability, Ascending Dose and Dose Frequency Study of Recombinant Human Heparan-N-sulfatase (rhHNS) Intrathecal Administration via an Intrathecal Drug Delivery Device in Pat...
    Medical condition: Sanfilippo Syndrome Type A or Mucopolysaccharidosis (MPS IIIA)
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10056890 Mucopolysaccharidosis III PT
    14.0 10010331 - Congenital, familial and genetic disorders 10056918 Sanfilippo's syndrome LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-001411-39 Sponsor Protocol Number: ABT-002 Start Date*: 2018-09-04
    Sponsor Name:Abeona Therapeutics Inc
    Full Title: Phase I/II gene transfer clinical trial of rAAV9.CMV.hNAGLU for Mucopolysaccharidosis (MPS) IIIB
    Medical condition: MPS IIIB is a devastating lysosomal storage disease, caused by a N-α-acetylglucosaminidase (NAGLU) gene defect. Infants with MPS IIIB appear normal at birth, but the disease is relentlessly progre...
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) DE (Prematurely Ended) FR (Prematurely Ended) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2015-000359-26 Sponsor Protocol Number: ESTEVE-SANF-201 Start Date*: 2016-04-29
    Sponsor Name:Laboratorios del Dr. Esteve, S.A.
    Full Title: Phase I/II safety, tolerability and initial efficacy study of adeno-associated viral vector serotype 9 containing human sulfamidase gene after intracerebroventricular administration to patients wit...
    Medical condition: Mucopolysaccharidosis type IIIA (Sanfilippo A syndrome) is an inherited lysosomal storage disease caused by a specific lysosomal enzyme deficiency that leads to intracellular accumulation of the ...
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-021348-16 Sponsor Protocol Number: HGT-SAN-067 Start Date*: 2011-02-09
    Sponsor Name:Shire Human Genetic Therapies, Inc
    Full Title: An Open-Label Extension of Study HGT-SAN-055 Evaluating Long Term Safety and Clinical Outcomes of Intrathecal Administration of rhHNS in Patients with Sanfilippo Syndrome Type A (MPS IIIA)
    Medical condition: Sanfilippo Syndrome Type A or Mucopolysaccharidosis (MPS IIIA)
    Disease: Version SOC Term Classification Code Term Level
    19.1 10010331 - Congenital, familial and genetic disorders 10056918 Sanfilippo's syndrome LLT
    19.1 10010331 - Congenital, familial and genetic disorders 10056890 Mucopolysaccharidosis III PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) NL (Completed)
    Trial results: View results
    EudraCT Number: 2015-003031-35 Sponsor Protocol Number: R04049 Start Date*: 2015-11-20
    Sponsor Name:Central Manchester University Hospitals NHS Foundation Trust
    Full Title: A Single Centre Study Investigating the Safety and Efficacy of an Immune Modulation Regimen in Mitigating the Alloimmune Response to Intravenous Laronidase in Infants With Severe Mucopolysaccharido...
    Medical condition: Severe Mucopolysaccharidosis Type I (Hurler syndrome, MPS IH)
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004850 10028094 Mucopolysaccharidosis IH LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-007829-40 Sponsor Protocol Number: DAM/003/08 Start Date*: 2009-01-29
    Sponsor Name:FARMACEUTICI DAMOR
    Full Title: Open-label, controlled, randomised, single centre, parallel group clinical trial of efficacy and tolerability of Clarema 1% cream and Hirudoid 40000 U.APTT gel in the topical treatment of haematoma...
    Medical condition: Patients with haematomas and subcutaneous haematic extravasations of traumatic origin
    Disease: Version SOC Term Classification Code Term Level
    9.1 10042345 Subcutaneous haematoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-005113-73 Sponsor Protocol Number: 20150114 Start Date*: 2016-07-01
    Sponsor Name:University Medical Center Groningen
    Full Title: Rotation for Optimal Targeting of Albuminuria and Treatment Evaluation
    Medical condition: Type 2 diabetes with albuminuria
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003904-21 Sponsor Protocol Number: ABT-001 Start Date*: 2016-08-01
    Sponsor Name:Abeona Therapeutics Inc
    Full Title: Phase I/II gene transfer clinical trial of scAAV9.U1a.hSGSH for Mucopolysaccharidosis (MPS) IIIA
    Medical condition: MPS IIIA is a devastating lysosomal storage disease, caused by a N-sulfoglucosamine sulfohydrolase gene defect. Infants with MPS IIIA appear normal at birth, but the disease is relentlessly progres...
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-000504-42 Sponsor Protocol Number: ABT-003 Start Date*: 2019-05-21
    Sponsor Name:Abeona Therapeutics Inc
    Full Title: A Phase I/II Open Label, Single-dose, Gene Transfer Study of scAAV9.U1a.hSGSH (ABO-102) in Patients with Middle and Advanced Phases of MPS IIIA Disease
    Medical condition: MPS IIIA is a devastating lysosomal storage disease, caused by a Nsulfoglucosamine sulfohydrolase gene defect. Infants with MPS IIIA appear normal at birth, but the disease is relentlessly progress...
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10056890 Mucopolysaccharidosis III PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-018343-34 Sponsor Protocol Number: 09P07 Start Date*: 2011-10-25
    Sponsor Name:Ludwigs Maximilians University
    Full Title: Comparison of 6% Hydroxyethyl Starch and 5% Albumin for Volume Replacement Therapy in Patients Undergoing Cystectomy (CHART study)
    Medical condition: Comparison of 6% Hydroxyethyl Starch and 5% Albumin for Volume Replacement Therapy in Patients Undergoing Cystectomy
    Disease: Version SOC Term Classification Code Term Level
    15.1 100000004861 10021139 Hypovolemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-005691-26 Sponsor Protocol Number: 201501252 Start Date*: 2016-07-14
    Sponsor Name:University Medical Center Groningen
    Full Title: Rotation for Optimal Targeting of Albuminuria and Treatment Evaluation
    Medical condition: Type 1 diabetes with albuminuria
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing) DK (Completed)
    Trial results: View results
    EudraCT Number: 2011-000212-25 Sponsor Protocol Number: HGT-HIT-046 Start Date*: 2012-01-05
    Sponsor Name:Shire HGT Inc
    Full Title: An Open-Label Extension of Study HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Intrathecal Idursulfase-IT Administered in Conjunction with Intravenous Elaprase® in Pediatric Pati...
    Medical condition: Treatment of Hunter syndrome and cognitive impairment
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10056889 Mucopolysaccharidosis II PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-001977-18 Sponsor Protocol Number: 201501252 Start Date*: 2017-09-26
    Sponsor Name:University Medical Center Groningen
    Full Title: Rotation for Optimal Targeting of Albuminuria and Treatment Evaluation (ROTATE-2)
    Medical condition: Type 2 diabetes and albuminuria
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-002806-10 Sponsor Protocol Number: SOBI003-001 Start Date*: Information not available in EudraCT
    Sponsor Name:Swedish Orphan Biovitrum AB (publ)
    Full Title: An open, non-controlled, parallel, ascending multiple-dose, multicenter study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SOBI003 in pediatric MPS IIIA patients
    Medical condition: Mucopolysaccharidosis Type IIIA or Sanfilippo Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10028094 Mucopolysaccharidosis IH LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-005612-40 Sponsor Protocol Number: DAM/001/08 Start Date*: 2008-11-27
    Sponsor Name:FARMACEUTICI DAMOR
    Full Title: Open-label, controlled, randomised, multicentre, parallel group clinical trial of efficacy and tolerability of heparan sulfate slow-release 120 mg tablets and defibrotide 400 mg capsules in the tre...
    Medical condition: Patients with chronic venous insufficiency
    Disease: Version SOC Term Classification Code Term Level
    9.1 10013283 Disorder vascular peripheral LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-001949-20 Sponsor Protocol Number: 1.0 Start Date*: 2023-01-09
    Sponsor Name:ALBIMMUNE S.L.
    Full Title: Human albumin treatment in adult septic shock. A phase 2, multicenter, randomized, controlled study evaluating the immune response and organ failure.
    Medical condition: Septic Shock
    Disease: Version SOC Term Classification Code Term Level
    23.1 10021881 - Infections and infestations 10040070 Septic shock PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-005200-35 Sponsor Protocol Number: DNLI-E-0007 Start Date*: Information not available in EudraCT
    Sponsor Name:Denali Therapeutics Inc.
    Full Title: A Phase 2/3, Multicenter, Double-Blind, Randomized Study to Determine the Efficacy and Safety of Tividenofusp (DNL310) vs Idursulfase in Pediatric and Young Adults Participants With Neuronopathic ...
    Medical condition: Mucopolysaccharidosis Type II [MPS II]
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10056889 Mucopolysaccharidosis II PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) NL (Trial now transitioned) ES (Ongoing) BE (Trial now transitioned) FR (Trial now transitioned) CZ (Trial now transitioned) SE (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-002314-17 Sponsor Protocol Number: JR-441-101 Start Date*: 2023-07-03
    Sponsor Name:JCR Pharmaceuticals Co., Ltd.
    Full Title: Phase I/II study of weekly infusions of JR-441 in patients with mucopolysaccharidosis type IIIA
    Medical condition: Mucopolysaccharidosis type IIIA (MPS IIIA) MPS III is an autosomal recessive disease characterized by the accumulation of HS in the tissues throughout the body due to a deficiency in enzymes involv...
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10056890 Mucopolysaccharidosis III PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (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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