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Clinical trials for Anal Fistula

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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    19 result(s) found for: Anal Fistula. Displaying page 1 of 1.
    EudraCT Number: 2009-014775-42 Sponsor Protocol Number: CX-401-0304 Start Date*: 2009-12-28
    Sponsor Name:CELLERIX S.A.
    Full Title: Estudio prospectivo para la evaluación de la seguridad y eficacia a largo plazo de Cx401 en pacientes que hayan participado en el ensayo clínico FATT2. A prospective study for the assessment of th...
    Medical condition: Fistula perianal compleja en la enfermedad perianal de Crohn Complex perianal fistula in perianal Crohn´s disease
    Disease: Version SOC Term Classification Code Term Level
    9 10002156 Anal fistula LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-003140-10 Sponsor Protocol Number: CX401-0303 Start Date*: 2008-10-03
    Sponsor Name:Cellerix, S.A.
    Full Title: Estudio prospectivo para la evaluación de la seguridad y eficacia a largo plazo de CX401 en pacientes que han participado en el ensayo FATT-1
    Medical condition: Fistula perianal compleja
    Disease: Version SOC Term Classification Code Term Level
    9 10002156 Anal fistula LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-007445-31 Sponsor Protocol Number: Cx601-0101 Start Date*: 2009-03-26
    Sponsor Name:Cellerix, S.A
    Full Title: Estudio multicéntrico fase I-IIa para evaluar la seguridad y eficacia de células madre expandidas derivadas de tejido adiposo alogénico (eASCs) (Cx601) para el tratamiento de las fístulas perianale...
    Medical condition: Tratamiento de las fístulas perianales complejas en la enfermedad perianal de Crohn.
    Disease: Version SOC Term Classification Code Term Level
    11.1 10002156 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2008-004286-25 Sponsor Protocol Number: CX-401/FATT2 Start Date*: 2008-12-04
    Sponsor Name:CELLERIX S.A.
    Full Title: Estudio fase III, multicéntrico, simple ciego, randomizado, controlado con placebo, para evaluar la eficacia y seguridad de células madre expandidas derivadas de tejido adiposo autólogo (eASCs) (CX...
    Medical condition: Fístula perianal compleja en pacientes con enfermedad de Crohn. Complex perianal fistula in perianal Crohn´s disease
    Disease: Version SOC Term Classification Code Term Level
    9 10002156 Anal fistula LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) NL (Completed) AT (Prematurely Ended) DE (Prematurely Ended) BE (Completed) CZ (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-003370-95 Sponsor Protocol Number: Cx401/FATT1 Start Date*: 2008-02-06
    Sponsor Name:CELLERIX, S.L.
    Full Title: "A Phase III multicenter, single blind, randomized, comparative, add?on clinical trial, in three parallel groups, to evaluate the efficacy and safety of a new therapy with adipose?derived autologou...
    Medical condition: Treatment of complex perianal fistulas in patients without inflammatory bowel disease.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10002156 Anal fistula LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) NL (Prematurely Ended) ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-006127-38 Sponsor Protocol Number: PRGF/AF/SIN/2011 Start Date*: 2012-06-05
    Sponsor Name:Fundación FISEVI
    Full Title: Phase II, open-label clinical trial to evaluate the safety and efficacy of platelet-rich plasma and fibrin clot in processed with PRGF-system technology, in the treatment of anal fistulas in Crohn'...
    Medical condition: Perianal fistulas in Crohn's Disease Patients
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10002156 Anal fistula PT
    14.1 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-000333-39 Sponsor Protocol Number: Darvadstrocel-3003 Start Date*: 2019-10-15
    Sponsor Name:Takeda Development Center Americas, Inc
    Full Title: A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn’s Disease Who Have Participated in ...
    Medical condition: Perianal fistulising Crohn´s disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10002156 Anal fistula PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) FR (Completed) HU (Completed) ES (Ongoing) BE (Completed) PL (Completed) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-002491-10 Sponsor Protocol Number: Alofisel-4001 Start Date*: 2020-03-10
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula
    Medical condition: Perianal fistulising Crohn´s disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10002156 Anal fistula PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Trial now transitioned) ES (Ongoing) DE (Trial now transitioned) FR (Ongoing) AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-006064-43 Sponsor Protocol Number: Cx601-0302 Start Date*: 2012-09-27
    Sponsor Name:TiGenix S.A.U.
    Full Title: A phase III, randomised, double blind, parallel group, placebo controlled, multicentre study to assess efficacy and safety of expanded allogeneic adipose-derived stem cells (eASCs) for the treatm...
    Medical condition: Perianal fistulising Crohn´s disease
    Disease: Version SOC Term Classification Code Term Level
    17.1 10017947 - Gastrointestinal disorders 10002156 Anal fistula PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) ES (Completed) IT (Completed) AT (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2019-001002-18 Sponsor Protocol Number: HUGTP-CIR-OFF Start Date*: 2021-05-04
    Sponsor Name:Hospital Universitari Germans Trias i Pujol
    Full Title: Pathophysiological mechanisms in the development of anal fistula. Oral antibiotics after anal abscess drainage to diminish perianal Fistula Formation: a multicenter, randomized, observer-blind, pla...
    Medical condition: Abscess and anal fistulas
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-003376-14 Sponsor Protocol Number: 1 Start Date*: 2021-11-26
    Sponsor Name:Mariano Artes Caselles
    Full Title: Efficacy of amoxicillin/clavulanic acid after surgical drainage of perianal abscess in the prevention of the development of anal fistula. A randomized, double-blind clinical trial.
    Medical condition: perianal abscess
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-002579-16 Sponsor Protocol Number: FFF/2013 Start Date*: 2014-12-09
    Sponsor Name:C. HOSPITALARIO VIRGEN DEL ROCIO
    Full Title: PHASE III CLINICAL TRIAL, single-center, randomized, double blind IN TWO GROUPS PARALLELS TO COMPARE THE EFFICACY AND SAFETY OF RICH PLASMA GROWTH FACTORS (PRGF) IN FRONT OF fibrin glue (TISSUCOL ...
    Medical condition: Anal and criptoglandular fistula
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-001209-34 Sponsor Protocol Number: PRGFFC17 Start Date*: 2018-05-28
    Sponsor Name:FISEVI
    Full Title: Phase III CLINICAL TRIAL, MULCHNTRIC, RANDOMIZED, BLIND DOUBLE IN TWO PARALLEL GROUPS TO COMPARE THE EFFECTIVENESS AND SAFETY OF THE SIMPLE CLOSURE OF THE CRYPTTOGLANDULAR ANAL FISTULA WITH OR WITH...
    Medical condition: Patients with anal fistula
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-004820-37 Sponsor Protocol Number: PRGF/AF/2011 Start Date*: 2012-06-13
    Sponsor Name:Fundación FISEVI
    Full Title: Phase II, open-label clinical trial to evaluate the safety and efficacy of platelet-rich plasma and fibrin clot processed with PRGF-System tecnology in the treatment of anal fistulas in Crohn's pat...
    Medical condition: Perianal fistulas in Crohn's Disease Patients
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10068659 Perianal fistula LLT
    14.1 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-004449-35 Sponsor Protocol Number: 80-86600-98-19047 Start Date*: 2021-05-06
    Sponsor Name:ZonMw
    Full Title: Antibiotic treatment following surgical drainage of perianal abscess: a double-blind, placebo-controlled, randomized trial
    Medical condition: Perianal fistula
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-002811-33 Sponsor Protocol Number: LAINCO1107 Start Date*: 2017-12-11
    Sponsor Name:LAINCO S.A
    Full Title: Unilateral, open and randomized phase IV study of 2 groups to assess the degree of comfort with simple Emuliquen® in patients undergoing proctological surgery
    Medical condition: Surgery proctological
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000016398 10042759 Symptoms involving digestive system LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2009-015680-14 Sponsor Protocol Number: allo bmMSCs CD fistula Start Date*: 2010-05-18
    Sponsor Name:Leiden University Medical Center
    Full Title: Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Fistulas in Patients with Refractory Perianal Crohn’s Disease
    Medical condition: single or multiple draining perianal fistulas as a result of Crohn's Disease
    Disease: Version SOC Term Classification Code Term Level
    12.1 10011401 Crohn's disease LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-002311-41 Sponsor Protocol Number: 2014-3 Start Date*: 2014-08-12
    Sponsor Name:GETAID
    Full Title: A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustaine...
    Medical condition: Luminal Crohn’s disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 1 year
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Ongoing) GB (GB - no longer in EU/EEA) SE (Ongoing) DE (Ongoing) NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-001295-65 Sponsor Protocol Number: TXC-CD-002-2011 Start Date*: 2014-11-28
    Sponsor Name:TxCell
    Full Title: A phase IIb, multicentre, randomised, double-blinded (DB), placebo-controlled, single-dose and parallel-group study to evaluate the efficacy and the safety of Ovasave (ovalbumin-specific autologous...
    Medical condition: Moderately to severely active Crohn's Disease
    Disease: Version SOC Term Classification Code Term Level
    19.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) AT (Completed) IT (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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