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Clinical trials for Clostridium histolyticum

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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    • 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   44335   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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    17 result(s) found for: Clostridium histolyticum. Displaying page 1 of 1.
    EudraCT Number: 2018-003637-14 Sponsor Protocol Number: AGO/2018/004 Start Date*: 2019-03-29
    Sponsor Name:Ghent University Hospital
    Full Title: Local injection of collagenase clostridium histolyticum (XiapexR) for refractory gastrointestinal strictures: an open-label pilot study.
    Medical condition: refractory iatrogenic gastrointestinal strictures
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004863 10078825 Gastrointestinal anastomotic stricture LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-005384-66 Sponsor Protocol Number: AUX-CC-807 Start Date*: 2014-04-28
    Sponsor Name:Endo Ventures Limited
    Full Title: A phase 3b, open-label pilot study to evaluate the safety and effectiveness of up to four treatment cycles of AA4500 in combination with the ErecAid® Esteem® Manual Vacuum Therapy System in men wit...
    Medical condition: Peyronie's Disease
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-005065-21 Sponsor Protocol Number: AUX-CC-862 Start Date*: 2012-03-26
    Sponsor Name:Auxilium UK Limited
    Full Title: Retreatment of recurrent contractures in joints effectively treated with AA4500 (collagenase clostridium histolyticum [XIAFLEX®/XIAPEX®]) in an Auxilium-sponsored Phase 3 Study in the United States...
    Medical condition: Dupuytren's contracture
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10013872 Dupuytren's contracture PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-000494-67 Sponsor Protocol Number: 1.2 Start Date*: 2013-10-22
    Sponsor Name:Klinik for håndkirurgi, Gentofte hospital
    Full Title: Needle fasciotomi vs collagenase for treatment of Dupuytrens contracture in 2nd, 3rd, 4th and 5th metacarpophalangeal joint.
    Medical condition: Dupuytrens contracture
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004859 10065799 Fibrosis deep connective tissue LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2010-019888-10 Sponsor Protocol Number: B1531002 Start Date*: 2010-11-10
    Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017
    Full Title: PROSPECTIVE OPEN-LABEL INVESTIGATION OF THE NON-SURGICAL TREATMENT WITH COLLAGENASE CLOSTRIDIUM HISTOLYTICUM (XIAPEX®)
    Medical condition: Dupuytren’s contracture
    Disease: Version SOC Term Classification Code Term Level
    12.1 10013873 Dupuytren's contracture operation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) ES (Completed) SE (Completed) DK (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-001221-13 Sponsor Protocol Number: 2639063 Start Date*: 2013-10-10
    Sponsor Name:Akershus university hospital
    Full Title: Dupytren’s disease study A randomized controlled trial comparing clostridium histolyticum with needle aponeurotomy.
    Medical condition: Dupytren’s disease, primary MCP joint contractures of the third, forth and fifth finger of the hand.
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004859 10009904 Collagen disorder NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-005215-41 Sponsor Protocol Number: 5.5 Start Date*: 2017-05-05
    Sponsor Name:Olli Leppänen
    Full Title: DupuytrEn Treatment EffeCtiveness Trial (DETECT): a protocol for prospective, randomized, controlled, outcome assessor-blinded, three armed parallel 1:1:1, multicenter trial comparing efficacy and ...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    19.1 10028395 - Musculoskeletal and connective tissue disorders 10013872 Dupuytren's contracture PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-000516-28 Sponsor Protocol Number: 39032 Start Date*: 2012-06-14
    Sponsor Name:University Medical Centre Groningen
    Full Title: A prospective clinical study on the efficacy of collagenase clostridium histolyticum (CCH) injections in the thumb and first web space contractures in Dupuytren's Disease
    Medical condition: Dupuytren's Disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-007872-99 Sponsor Protocol Number: AUX-CC-860 Start Date*: 2010-02-01
    Sponsor Name:Auxilium UK Limited
    Full Title: Long term follow up of subjects treated with AA4500 in studies AUX-CC-854, AUX-CC-856, AUX-CC-857/AUX-CC-858 and AUX-CC-859
    Medical condition: Dupuytren's contracture
    Disease: Version SOC Term Classification Code Term Level
    14.0 10028395 - Musculoskeletal and connective tissue disorders 10013872 Dupuytren's contracture PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) DK (Completed) SE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-001656-22 Sponsor Protocol Number: 1601 Start Date*: 2016-11-17
    Sponsor Name:Ziekenhuis Oost Limburg
    Full Title: The utility of liposomal bupivacaine for anesthesia and analgesia in patients treated with collagenase for the release of Dupuytren’s contracture: A randomized controlled trial.
    Medical condition: Introduction of collagenase clostridium histolyticum injection for the treatment of Dupuytren’s contractures.
    Disease: Version SOC Term Classification Code Term Level
    19.0 10042613 - Surgical and medical procedures 10013873 Dupuytren's contracture operation PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-022921-13 Sponsor Protocol Number: AUX-CC-802 Start Date*: 2011-01-24
    Sponsor Name:Auxilium UK Limited
    Full Title: A PHASE 3, OPEN-LABEL STUDY OF THE SAFETY AND EFFECTIVENESS OF AA4500 ADMINISTERED TWICE PER TREATMENT CYCLE FOR UP TO FOUR TREATMENT CYCLES (2 x 4) IN MEN WITH PEYRONIE’S DISEASE
    Medical condition: Peyronie's Disease
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038604 - Reproductive system and breast disorders 10034765 Peyronie's disease PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: SE (Completed) GB (Completed) DE (Completed) DK (Completed) FR (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-004239-37 Sponsor Protocol Number: AUX-CC-810 Start Date*: 2015-02-26
    Sponsor Name:Auxilium UK Limited
    Full Title: Long-term safety, curvature deformity characterization, and immunogenicity over time in subjects previously treated with AA4500 for Peyronie’s disease in studies AUX-CC-802, AUX-CC-803, AUX CC 804,...
    Medical condition: Peyronie's Disease
    Disease: Version SOC Term Classification Code Term Level
    17.1 10038604 - Reproductive system and breast disorders 10034766 Peyronies disease LLT
    17.1 10038604 - Reproductive system and breast disorders 10034765 Peyronie's disease PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: SE (Completed) GB (Completed) DK (Completed) ES (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-005357-23 Sponsor Protocol Number: 01 Start Date*: 2013-01-27
    Sponsor Name:AUSL VITERBO
    Full Title: Preventing injection pain by Clostridium Histolyticum Collagenase Administration for teatment of Dupuytrens contracture
    Medical condition: Dupuytren s Disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10028395 Musculoskeletal and connective tissue disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-004649-28 Sponsor Protocol Number: CTO-201 Start Date*: 2015-10-09
    Sponsor Name:Matrizyme Pharma Corporation
    Full Title: A 2-stage study to evaluate single doses of MZ-004 at different dose levels in patients with chronic total occlusions. STAGE 1: Open label Training Stage. STAGE 2: Double-blind, randomized, Pla...
    Medical condition: The use of MZ-004 to facilitate percutaneous coronary intervention in symptomatic patients with a chronic total occlusion who are indicated for revascularization
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-004251-76 Sponsor Protocol Number: 87230 Start Date*: 2017-05-22
    Sponsor Name:University Hospitals of Leicester NHS Trust
    Full Title: A pragmatic multi-centre randomised controlled non-inferiority, cost effectiveness trial comparing injections of collagenase into the cord to surgical correction in the treatment of moderate Dupuyt...
    Medical condition: Dupuytren's contracture
    Disease: Version SOC Term Classification Code Term Level
    19.1 10028395 - Musculoskeletal and connective tissue disorders 10013872 Dupuytren's contracture PT
    19.1 10042613 - Surgical and medical procedures 10013873 Dupuytren's contracture operation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2012-004091-19 Sponsor Protocol Number: AUX-CC-867 Start Date*: 2012-12-28
    Sponsor Name:Auxilium UK Limited
    Full Title: A Phase 3b open-label, historically-controlled study to assess the safety and efficacy of two concurrent injections of AA4500 in adult subjects with multiple Dupuytren’s contractures with palpable ...
    Medical condition: Dupuytren's contracture
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10013872 Dupuytren's contracture PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) GB (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2014-001672-55 Sponsor Protocol Number: MW2010-03-02 Start Date*: 2014-09-22
    Sponsor Name:MediWound Ltd.
    Full Title: A multicenter, multinational, randomized, controlled, assessor blinded study, performed in subjects with thermal burns, to evaluate the efficacy and safety of NexoBrid compared to Gel Vehicle and c...
    Medical condition: The study objective is to evaluate the efficacy and safety of NexoBrid in removing burn eschar in hospitalized subjects with thermal burns.
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004863 10043418 Thermal burns HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) RO (Completed) LV (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
    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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