Plasma rico en plaquetas y coagulo de fibrina procesados mediante la tecnología PRGF-System (BTI) ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
96クローン病2

96. クローン病


臨床試験数 : 2,442 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2011-004820-37-ES
(EUCTR)
13/06/201215/02/2012Experimental study in humans to evaluate the efficacy and safety of bloodproducts rich in proteins for the treatment of anal fistulas in Crohn'spatientsPhase 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 patients Perianal fistulas in Crohn's Disease Patients
MedDRA version: 14.1;Level: LLT;Classification code 10068659;Term: Perianal fistula;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
Product Name: Plasma rico en plaquetas y coagulo de fibrina procesados mediante la tecnología PRGF-System (BTI)
INN or Proposed INN: Plasma rico en plaquetas y coagulo de fibrina procesados mediante la tecnología PRGF-System (BTI)
Other descriptive name: HUMAN PLASMA FOR FRACTIONATION
Fundación FISEVINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Spain
2EUCTR2011-006127-38-ES
(EUCTR)
05/06/201215/02/2012Experimental study in humans to evaluate the efficacy and safety of blood products rich in proteins for the treatment of anal fistulas in Crohn's patients without subsidiary drug treatment.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's patients with no concomitant therapy with second-line drugs. Perianal fistulas in Crohn's Disease Patients
MedDRA version: 14.1;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
Product Name: Plasma rico en plaquetas y coagulo de fibrina procesados mediante la tecnología PRGF-System (BTI)
INN or Proposed INN: Plasma rico en plaquetas y coagulo de fibrina procesados mediante la tecnología PRGF-System (BTI)
Other descriptive name: HUMAN PLASMA FOR FRACTIONATION
Fundación FISEVINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Spain