JPRN-jRCT2080222987已完成3 期
A RANDOMIZED, MULTICENTER, OPEN-LABEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PROPHYLACTIC EMICIZUMAB VERSUS NO PROPHYLAXIS IN HEMOPHILIA A PATIENTS WITH INHIBITORS
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 109
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 12age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)Aged 12 years or older at the time of informed consent
- •2)Diagnosis of congenital hemophilia A of any severity and documented history of high-titer inhibitor (i.e., >= 5 Bethesda Units)
- •3)Documentation of treatment with episodic or prophylactic bypassing agents for at least the last 24 weeks
- •4)6 (if on an episodic bypassing agent regimen) or >= 2 (if on a prophylactic bypassing agent regimen) bleeds in the last 24 weeks
排除标准
- •1) Inherited or acquired bleeding disorder other than hemophilia A
- •2) Ongoing (or plan to receive during the study) immune tolerance induction therapy or prophylaxis with FVIII
- •3) Previous or current treatment for thromboembolic disease (with the exception of previous catheter-associated thrombosis for which antithrombotic treatment is not currently ongoing) or signs of thromboembolic disease
- •4) Previous or concurrent autoimmune or connective tissue disease
研究者
相似试验
进行中（未招募）
1 期
A Phase III Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic RO5534262 versus No Prophylaxis in Hemophilia A Patients with InhibitorsHemophilia A with InhibitorsMedDRA version: 20.0Level: LLTClassification code 10060612Term: Hemophilia ASystem Organ Class: 100000004850MedDRA version: 20.0Level: LLTClassification code 10053751Term: Hemophilia A with anti factor VIIISystem Organ Class: 100000004850EUCTR2015-002866-21-FRF. Hoffmann-La Roche Ltd109
进行中（未招募）
1 期
A Study to Evaluate the Effectiveness and Safety of Prophylactic Emicizumab Versus no Prophylaxis in Haemophilia A Patients Without InhibitorsHaemophilia A without factor VIII inhibitorsMedDRA version: 20.0Level: LLTClassification code 10053753Term: Hemophilia A without inhibitorsSystem Organ Class: 100000004850EUCTR2016-000072-17-GBF. Hoffmann-La Roche Ltd152
进行中（未招募）
不适用
A Study of trastuzumab emtansine Plus Perjeta (Pertuzumab) Following Anthracyclines in Comparison With Herceptin (Trastuzumab) Plus Perjeta and a Taxane Following Anthracyclines as Adjuvant Therapy in Patients With Operable HER2-positive Primary Breast Cancer.HER2-positive operable primary breast cancer.MedDRA version: 14.1Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-004902-82-ESF. Hoffmann-La Roche Ltd2,500
进行中（未招募）
1 期
A Study of trastuzumab emtansine Plus Perjeta (Pertuzumab) Following Anthracyclines in Comparison With Herceptin (Trastuzumab) Plus Perjeta and a Taxane Following Anthracyclines as Adjuvant Therapy in Patients With Operable HER2-positive Primary Breast Cancer.EUCTR2012-004902-82-PLF. Hoffmann-La Roche Ltd1,846
进行中（未招募）
1 期
A Study of trastuzumab emtansine Plus Perjeta (Pertuzumab) Following Anthracyclines in Comparison With Herceptin (Trastuzumab) Plus Perjeta and a Taxane Following Anthracyclines as Adjuvant Therapy in Patients With Operable HER2-positive Primary Breast Cancer.HER2-positive operable primary breast cancer.MedDRA version: 23.0Level: PTClassification code 10065430Term: HER2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-004902-82-BEF. Hoffmann-La Roche Ltd1,846