EUCTR2005-004988-27-HU进行中（未招募）1 期
A PHASE II, MULTICENTRE, RANDOMISED, OPEN-LABEL, ACTIVE CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MICAFUNGIN SALVAGE MONO THERAPY VERSUS ACTIVE CONTROL INTRAVENOUS SALVAGE MONO THERAPY IN PATIENTS WITH INVASIVE ASPERGILLOSIS - Micafungin Salvage Mono Therapy in Invasive Aspergillosis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 135
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent to participate in the study. A patient unable to write and/or read but who fully understands the oral information given by the investigator (or nominated representative) has given oral informed consent witnessed in writing by an independent person. A patient who is unconscious where written informed consent is given by a legal representative in accordance with national regulations and after approval was obtained from the relevant Independent Ethics Committee
- •2. Patient with allogeneic or autologous haematopoietic stem cell transplantation (HSCT), acute leukaemia or myelodysplastic syndrome (MDS)
- •3. Patient is 18 years of age or older
- •4. Patient with proven (probable only in case of pulmonary aspergillosis) invasive aspergillosis at baseline as defined in Appendix II
- •5. Patient is either
- •a) refractory to at least 7 consecutive days of a systemic antifungal agent (amphotericin B products or voriconazole) used as first line therapy
- •b) intolerant to at least one dose of a systemic antifungal agent (amphotericin B products or voriconazole)
- •prior to study drug administration as defined in Appendix III
- •6. Female patient of child bearing potential must have a negative pregnancy test prior to enrolment and must agree to practice effective birth control during the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patient with allergic bronchopulmonary aspergillosis, chronic pulmonary aspergillosis, aspergilloma, or with sinus aspergillosis or external otitis without any evidence of Aspergillus tissue invasion
- •2. Patient with invasive fungal infection other than invasive aspergillosis
- •3. Patient has been previously enrolled in this study
- •4. Patient is pregnant or breast-feeding mother
- •5. Patient is unlikely to comply with the visits scheduled in the protocol
- •6. Patient is participating, or has participated, in another investigational drug trial or is receiving, or has received, an investigational drug within the last 28 days before entry into this study except for investigational drugs against cancer (e.g. leukaemia)
- •7. Patient with less than 7 days life expectancy
- •8. Patient had a previous salvage therapy for the current episode of Aspergillus infection
- •9. Patient with first line monotherapy of itraconazole solely for the current episode of Aspergillus infection
- •10. Patient with first line therapy of caspofungin used for the current episode of invasive aspergillosis
- •11. Patient with known hypersensitivity or intolerance to echinocandins or to any of the excipients.
研究者
相似试验
进行中（未招募）
1 期
A PHASE II, MULTICENTRE, RANDOMISED, OPEN-LABEL, ACTIVE CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MICAFUNGIN SALVAGE MONO THERAPY VERSUS ACTIVE CONTROL INTRAVENOUS SALVAGE MONO THERAPY IN PATIENTS WITH INVASIVE ASPERGILLOSIS - Micafungin Salvage Mono Therapy in Invasive AspergillosisEUCTR2005-004988-27-BEAstellas Pharma BV135
进行中（未招募）
1 期
A PHASE II, MULTICENTRE, RANDOMISED, OPEN-LABEL, ACTIVE CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MICAFUNGIN SALVAGE MONO THERAPY VERSUS ACTIVE CONTROL INTRAVENOUS SALVAGE MONO THERAPY IN PATIENTS WITH INVASIVE ASPERGILLOSIS - Micafungin Salvage Mono Therapy in Invasive AspergillosisPatients with haematopoietic stem cell transplantation (HSCT), acute leukaemia, myelodysplastic syndrome (MDS) and with proven (probable only in case of pulmonary aspergillosis) invasive aspergillosis and who are also refractory or intolerant to previous systemic antifungal therapy. Criteria for refractoriness and intolerance are defined in Appendix III of the study protocol.MedDRA version: 8.0Level: LLTClassification code 10022881EUCTR2005-004988-27-ESAstellas Pharma GmbH135
进行中（未招募）
不适用
A PHASE II, MULTICENTRE, RANDOMISED, OPEN-LABEL, ACTIVE CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MICAFUNGIN SALVAGE MONO THERAPY VERSUS ACTIVE CONTROL INTRAVENOUS SALVAGE MONO THERAPY IN PATIENTS WITH INVASIVE ASPERGILLOSIS - Micafungin Salvage Mono Therapy in Invasive AspergillosisPatients with haematopoietic stem cell transplantation (HSCT), acute leukaemia, myelodysplastic syndrome (MDS) and with proven (probable only in case of pulmonary aspergillosis) invasive aspergillosis and who are also refractory or intolerant to previous systemic antifungal therapy. Criteria for refractoriness and intolerance are defined in Appendix III of the study protocol.MedDRA version: 8.1Level: LLTClassification code 10022881Term: Invasive bronchopulmonary aspergillosisEUCTR2005-004988-27-DEAstellas Pharma BV135
进行中（未招募）
不适用
A PHASE II, MULTICENTRE, RANDOMISED, OPEN-LABEL, ACTIVE CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MICAFUNGIN SALVAGE MONO THERAPY VERSUS ACTIVE CONTROL INTRAVENOUS SALVAGE MONO THERAPY IN PATIENTS WITH INVASIVE ASPERGILLOSIS - Micafungin Salvage Mono Therapy in Invasive AspergillosisPatients with haematopoietic stem cell transplantation (HSCT), acute leukaemia, myelodysplastic syndrome (MDS) and with proven (probable only in case of pulmonary aspergillosis) invasive aspergillosis and who are also refractory or intolerant to previous systemic antifungal therapy. Criteria for refractoriness and intolerance are defined in Appendix III of the study protocol.MedDRA version: 9.1Level: LLTClassification code 10003488Term: AspergillosisEUCTR2005-004988-27-ITASTELLAS PHARMA135
进行中（未招募）
不适用
PHASE II MULTI-CENTRIC, RANDOMISED, OPEN-LABEL, PARALLEL-GROUP STUDY TO ASSESS THE NON-INFERIORITY OF PAMORELIN® 11,25MG SC INJECTED VERSUS PAMORELIN® 11,25MG IM INJECTED IN PATIENTS SUFFERING FROM ADVANCED PROSTATE CANCER - PAMOJECTPatients with advanced (locally or metastatic) prostate cancer scheduled to receive an LHRH analogue as androgen deprivation therapyEUCTR2005-005058-31-NLIPSEN FARMACEUTICA BV210