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Ofatumumab vs Physician's Choice in Subjects With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukemia

2018年10月9日 更新者：Novartis Pharmaceuticals

An Open Label, Multicenter Study Investigating the Safety and Efficacy of Ofatumumab Therapy Versus Physicians' Choice in Patients With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukaemia (CLL)

The purpose of this study was to confirm the clinical benefit observed in the pivotal registration study, Hx-CD20-406. The Committee for Medicinal Products for Human Use (CHMP) required that a randomized study be conducted in CLL patients with bulky fludarabine-refractory disease as a specific obligation for grant of conditional approval for ARZERRA™ in the European Union (EU). This study compared ofatumumab with the physicians' choice of therapy.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Patients with CLL that is refractory to fludarabine have few treatment options and a poor prognosis. There is a continued need for new therapies for these CLL patients, as demonstrated by the limited responses and substantial toxicities with existing therapies. This is supported by the lack of a consensus around standard of care treatment for CLL patients with bulky fludarabine-refractory disease. The objective of this study was to confirm the response rate and disease control in the refractory setting through a controlled trial comparing ofatumumab with the physicians' choice of therapy in fludarabine-refractory, bulky lymphadenopathy patients. After 24 weeks of treatment with ofatumumab, patients were further randomized to either extended ofatumumab treatment or observation. Patients on the physicians' choice arm had the option of receiving ofatumumab if they experience progressive disease.

研究类型

介入性

注册 (实际的)

122

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 乌克兰
      • Cherkasy、乌克兰、18009
        • Novartis Investigative Site
      • Dnipropetrovsk、乌克兰、49102
        • Novartis Investigative Site
      • Donetsk、乌克兰、83045
        • Novartis Investigative Site
      • Kharkiv、乌克兰、61070
        • Novartis Investigative Site
      • Khmelnytskyi、乌克兰、29000
        • Novartis Investigative Site
      • Kyiv、乌克兰、03022
        • Novartis Investigative Site
      • Kyiv、乌克兰、04112
        • Novartis Investigative Site
      • Lviv、乌克兰、79044
        • Novartis Investigative Site
      • Makiivka、乌克兰、86132
        • Novartis Investigative Site
      • Simferopil、乌克兰、95023
        • Novartis Investigative Site
      • Vinnitsa、乌克兰、21018
        • Novartis Investigative Site
      • Zhytomyr、乌克兰、10002
        • Novartis Investigative Site
  • 以色列
      • Jerusalem、以色列、91120
        • Novartis Investigative Site
      • Ramat Gan、以色列、52621
        • Novartis Investigative Site
  • 俄罗斯联邦
      • Chelyabinsk、俄罗斯联邦、454076
        • Novartis Investigative Site
      • Moscow、俄罗斯联邦、115478
        • Novartis Investigative Site
      • St'Petersburg、俄罗斯联邦、197341
        • Novartis Investigative Site
      • St. Petersburg、俄罗斯联邦、198205
        • Novartis Investigative Site
  • 保加利亚
      • Sofia、保加利亚、1431
        • Novartis Investigative Site
      • Sofia、保加利亚、1407
        • Novartis Investigative Site
      • Sofia、保加利亚、1233
        • Novartis Investigative Site
  • 匈牙利
      • Budapest、匈牙利、1097
        • Novartis Investigative Site
      • Debrecen、匈牙利、4012
        • Novartis Investigative Site
      • Pecs、匈牙利、7624
        • Novartis Investigative Site
      • Szombathely、匈牙利、9700
        • Novartis Investigative Site
  • 奥地利
      • Graz、奥地利、8036
        • Novartis Investigative Site
      • Innsbruck、奥地利、6020
        • Novartis Investigative Site
      • Linz、奥地利、4020
        • Novartis Investigative Site
      • Salzburg、奥地利、A-5020
        • Novartis Investigative Site
      • Wien、奥地利、1140
        • Novartis Investigative Site
  • 德国
    • Bayern
      • Kronach、Bayern、德国、96317
        • Novartis Investigative Site
      • Regensburg、Bayern、德国、93053
        • Novartis Investigative Site
    • Brandenburg
      • Frankfurt/Oder、Brandenburg、德国、15236
        • Novartis Investigative Site
    • Hessen
      • Frankfurt、Hessen、德国、60590
        • Novartis Investigative Site
    • Nordrhein-Westfalen
      • Essen、Nordrhein-Westfalen、德国、45122
        • Novartis Investigative Site
      • Koeln、Nordrhein-Westfalen、德国、50937
        • Novartis Investigative Site
    • Rheinland-Pfalz
      • Koblenz、Rheinland-Pfalz、德国、56068
        • Novartis Investigative Site
    • Sachsen
      • Chemnitz、Sachsen、德国、09113
        • Novartis Investigative Site
      • Dresden、Sachsen、德国、01307
        • Novartis Investigative Site
    • Sachsen-Anhalt
      • Magdeburg、Sachsen-Anhalt、德国、39130
        • Novartis Investigative Site
  • 意大利
    • Emilia-Romagna
      • Modena、Emilia-Romagna、意大利、41124
        • Novartis Investigative Site
    • Lombardia
      • Brescia、Lombardia、意大利、25123
        • Novartis Investigative Site
      • Milano、Lombardia、意大利、20162
        • Novartis Investigative Site
      • Milano、Lombardia、意大利、20132
        • Novartis Investigative Site
    • Piemonte
      • Torino、Piemonte、意大利、10126
        • Novartis Investigative Site
    • Sicilia
      • Messina、Sicilia、意大利、95158
        • Novartis Investigative Site
  • 捷克语
      • Hradec Kralove、捷克语
        • Novartis Investigative Site
      • Olomouc、捷克语、775 20
        • Novartis Investigative Site
      • Praha 2、捷克语、128 08
        • Novartis Investigative Site
  • 斯洛伐克
      • Bratislava、斯洛伐克、833 10
        • Novartis Investigative Site
      • Bratislava、斯洛伐克、851 07
        • Novartis Investigative Site
      • Kosice、斯洛伐克、041 66
        • Novartis Investigative Site
      • Martin、斯洛伐克、036 59
        • Novartis Investigative Site
  • 新加坡
      • Singapore、新加坡、169608
        • Novartis Investigative Site
  • 比利时
      • Bruxelles、比利时、1200
        • Novartis Investigative Site
      • Leuven、比利时、3000
        • Novartis Investigative Site
  • 法国
      • Bobigny cedex、法国、93009
        • Novartis Investigative Site
      • Brest cedex、法国、29609
        • Novartis Investigative Site
      • Clermont-Ferrand Cedex 1、法国、63003
        • Novartis Investigative Site
      • Creteil cedex、法国、94010
        • Novartis Investigative Site
      • Lille cedex、法国、59037
        • Novartis Investigative Site
      • Rennes cedex 9、法国、35033
        • Novartis Investigative Site
      • Toulouse cedex 9、法国、31059
        • Novartis Investigative Site
      • Tours cedex 9、法国、37044
        • Novartis Investigative Site
  • 波兰
      • Chorzow、波兰、41-500
        • Novartis Investigative Site
      • Lodz、波兰、93-510
        • Novartis Investigative Site
      • Wroclaw、波兰、50-367
        • Novartis Investigative Site
  • 爱尔兰
      • Dublin、爱尔兰、7
        • Novartis Investigative Site
      • Galway、爱尔兰
        • Novartis Investigative Site
      • James Street、爱尔兰、8
        • Novartis Investigative Site
  • 瑞典
      • Goteborg、瑞典、SE-413 45
        • Novartis Investigative Site
      • Linkoping、瑞典、SE-581 85
        • Novartis Investigative Site
      • Lulea、瑞典、SE-971 80
        • Novartis Investigative Site
      • Orebro、瑞典、SE-701 85
        • Novartis Investigative Site
      • Stockholm、瑞典、SE-171 76
        • Novartis Investigative Site
      • Umea、瑞典、SE-901 85
        • Novartis Investigative Site
      • Uppsala、瑞典、SE-751 85
        • Novartis Investigative Site
  • 英国
      • Bournemouth、英国、BH7 7DW
        • Novartis Investigative Site
      • Manchester、英国、M20 4BX
        • Novartis Investigative Site
      • Oxford、英国、OX3 7LE
        • Novartis Investigative Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adults with documented diagnosis of active CLL requiring treatment
  • Bulky lymphadenopathy, defined as at least 1 lymph node >5 cm
  • Must be refractory to fludarabine treatment
  • Age 18 yrs or older
  • At least 2 prior therapies for CLL
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Signed written informed consent

Exclusion Criteria:

  • Prior allogeneic stem cell transplant at any time, or autologous stem cell transplant within 6 months
  • Treatment with any unapproved drug substance or experimental therapy within 4 weeks, or currently participating in another interventional clinical study
  • CLL transformation, prolymphocytic leukemia, or central nervous system (CNS) involvement of CLL
  • Active autoimmune hemolytic anemia (AIHA) requiring treatment except if associated with progressive disease requiring anti-CLL treatment
  • Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment
  • Human immunodeficiency virus (HIV) positive
  • Significant concurrent, uncontrolled medical condition
  • Other past or current malignancy (with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix or breast) unless the tumor was successfully treated with curative intent at least 2 years prior to trial entry
  • Non-protocol corticosteroid usage except a maintenance dose corresponding to less than or equal to 10 mg prednisone
  • Abnormal lab values: Creatinine > 2.0 times upper normal limit (unless normal creatinine clearance), or total bilirubin > 2.0 times upper normal limit (unless due to liver involvement of CLL or due to Gilbert's syndrome), or alanine transaminase (ALT) > 2.5 times upper normal limit (unless due to liver involvement of CLL)
  • Known or suspected hypersensitivity to ofatumumab
  • Lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Ofatumumab
Biological
药品：Ofatumumab
Ofatumumab IV, initial dose 300 mg, followed 1 week later with 2000 mg once weekly for 7 weeks, followed 4 weeks later by one infusion of 2000 mg every 4 weeks for 4 infusions, for a total of 12 infusions over 24 weeks. After 24 weeks of ofatumumab treatment, patients who have achieved at least stable disease or better, and whom the investigator would deem appropriate for the therapy to continue, would undergo a second randomisation (2:1) to either 1) an additional ofatumumab dose regimen of 2000 mg once every 4 weeks for up to an additional 24 weeks, or 2) no further therapy (i.e. observation only).
有源比较器：Physicians' Choice
Physicians' choice of treatment
药品：Physicians' Choice
Non-ofatumumab containing regimen as per physicians' choice for up to 6 months. Permitted therapies include treatments approved for CLL, and well established standards of care for CLL.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Progression-free Survival (PFS) as Assessed by Independent Review Committee (IRC)
大体时间：From the randomization date up to 60 months post the randomization date.
PFS is the interval of time between the date of first randomization to the date of disease progression (PD) or death due to any reason, whichever occurred first. The date of PD was defined as the first occurrence of any criteria of progression. PD criteria requires at least one of the following: progression of lymphadenopathy, >=50% increase in liver or spleen size, >=50% increase in number of lymphocytes per microliter, more aggressive histology, occurence of cytopenia after treatment attributable to CLL. Disease progression was determined according to the 2008 International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) update of the National Cancer Institute-sponsored Working Group CLL Guidelines for Response (NCI-WG). PFS was censored at the time of the last follow up for participants who have neither progressed or died.
From the randomization date up to 60 months post the randomization date.

次要结果测量

结果测量
措施说明
大体时间
Progression-free Survival (PFS) as Assessed by Investigator
大体时间：From the randomization date up to 60 months post the randomization date.
PFS is the interval of time between the date of first randomization to the date of disease progression (PD) or death due to any reason, whichever occurred first. The date of PD was defined as the first occurrence of any criteria of progression. PD criteria requires at least one of the following: progression of lymphadenopathy, >=50% increase in liver or spleen size, >=50% increase in number of lymphocytes per microliter, more aggressive histology, occurence of cytopenia after treatment attributable to CLL. Disease progression was determined according to the 2008 International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) update of the National Cancer Institute-sponsored Working Group CLL Guidelines for Response (NCI-WG). PFS was censored at the time of the last follow up for participants who have neither progressed or died.
From the randomization date up to 60 months post the randomization date.
Overall Response Rate (ORR) as Assessed by the IRC
大体时间：From the randomization date up to 60 months post the randomization date.
ORR is defined as the number of participants achieving either complete response (CR) or partial response (PR). ORR was measured using the IWCLL updated NCI-WG guidelines 2008. CR requires all of the following criteria: no lymphadenopathy(Ly)/ hepatomegaly, splenomegaly, constitutional symptoms; neutrophils >1500 per microliter(µL), platelets(PL) >100,000/µL, hemoglobin(Hb) >11 grams/deciliter(g/dL), lymphocytes(LC) <4000/µL, bone marrow(BM) sample must be normocellular for age, <30% LC and no lymphoid nodules. PR requires the following criteria for at least 2 months: >=50% decrease in LC, reduction in Ly (i.e., >=50% decrease in lymph node size or no increase or new lymph nodes), >=50% decrease in the size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline(BL), Hb >11 g/dL or 50% improvement over BL, neutrophils>1500/μL. Nodular PR (nPR) indicates persistent nodules in the BM.
From the randomization date up to 60 months post the randomization date.
Overall Response Rate (ORR) as Assessed by the Investigator
大体时间：From the randomization date up to 60 months post the randomization date.
ORR is defined as the number of participants achieving either complete response (CR) or partial response (PR). Overall response was measured using the IWCLL updated NCI-WG guidelines 2008. CR requires all of the following criteria: no lymphadenopathy(Ly)/ hepatomegaly, splenomegaly, constitutional symptoms; neutrophils >1500 per microliter(µL), platelets(PL) >100,000/µL, hemoglobin(Hb) >11 grams/deciliter(g/dL), lymphocytes(LC) <4000/µL, bone marrow(BM) sample must be normocellular for age, <30% LC and no lymphoid nodules. PR requires the following criteria for at least 2 months: >=50% decrease in LC, reduction in Ly (i.e., >=50% decrease in lymph node size or no increase or new lymph nodes), >=50% decrease in the size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline(BL), Hb >11 g/dL or 50% improvement over BL, neutrophils>1500/μL. Nodular PR (nPR) indicates persistent nodules in the BM.
From the randomization date up to 60 months post the randomization date.
Overall Survival
大体时间：From the randomization date up to 60 months post the randomization date.
Overall survival (OS) is defined as the time from randomization to death due to any cause. Kaplan-Meier plots were used to estimate the reported median OS time.
From the randomization date up to 60 months post the randomization date.
Time to Progression as Assessed by IRC
大体时间：From the randomization date up to 60 months post the randomization date.
Time to progression is defined as the time from the date of randomization to disease progression (PD). PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Participants who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time were censored at the date of the last visit with adequate assessment.
From the randomization date up to 60 months post the randomization date.
Time to Next Anti-cancer Therapy by Investigator
大体时间：From the randomization date up to 60 months post the randomization date.
Time to next therapy is defined as the time from randomization until the start of the next line of treatment.
From the randomization date up to 60 months post the randomization date.
Time to Response as Assessed by the IRC
大体时间：From the randomization date up to 60 months post the randomization date.
Time to response is defined as the time from randomization to the first response (Complete Remission[CR], Complete Remission with incomplete bone marrow recovery[CRi], partial response[PR], or nodular PR[nPR]). CR(all the criteria at least 2 months after last treatment): no lymphadenopathy(Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter(µL), platelets(PL) >100,000/µL, hemoglobin(Hb) >11 grams/deciliter(g/dL), lymphocytes(LC) <4000/µL, bone marrow(BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline(BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM. Participants with unknown or missing responses were considered as non-responders.
From the randomization date up to 60 months post the randomization date.
Duration of Response as Assessed by the IRC
大体时间：From the randomization date up to 60 months post the randomization date.
DOR is defined as the time from the initial response (CR, CRi, nPR, or PR) to the first documented sign of PD or death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Par. who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time (>= 12 weeks) were censored at the date of the last visit with adequate assessment. Par. with unknown or missing responses were considered as non-responders.
From the randomization date up to 60 months post the randomization date.
Number of Participants With Any Adverse Event (AE), Any Serious Adverse Event (SAE), Any Fatal Serious Adverse Event (FSAE), or Deaths
大体时间：From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect.
From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy
Number of Participants With Any Adverse Event (AE) of Special Interest
大体时间：From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy
AEs of special interest included cytopenias (neutropenia [decreased neutrophil count], anaemia [decreased hemoglobin], and thrombocytopenia [decreased platelet count]), autoimmune haematologic complications (autoimmune haemolytic anaemia and haemolytic anaemia), infusion reactions, infections, mucocutaneous reactions, Tumour Lysis Syndrome (TLS), cardiovascular events, and small bowel obstruction.
From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
大体时间：Screening and every 3 months during treatment, every 6 months after last treatment until PD or until 42 Month Follow-up Visit
Immunoglobulins or antibodies are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Immunoglobulin testing was performed at Screening (SCR), Cycle 3 Week 4 (C3W4), Cycle 7 Week 4 (C3W4) ,Cycle 9 Week 4 (C3W4), 6 Month Follow-up Visit (6M FU), 9 Month Follow-up (9M FU), 12 Month Follow-up (12M FU), 18 Month Follow-up (18M FU), 24 Month Follow-up (24M FU), 30 Month Follow-up (30M FU), 36 Month Follow-up (36M FU), 42 Month Follow-up (42M FU). A cycle is defined as the time between one round of treatment until the start of the next round.
Screening and every 3 months during treatment, every 6 months after last treatment until PD or until 42 Month Follow-up Visit
Number of Participants Who Were Positive or Negative for Human Anti-Human Antibodies (HAHA) Post-OFA Therapy
大体时间：From the randomization date up to 60 months post the randomization date.
The presence of HAHA in human serum was determined using a validated electrochemiluminescent assay in a multi-tier assay format. All samples were first assessed in a screening (SCR) assay, and the potential positive (Pos) samples were further tested in the confirmation (CNF) assays. Confirmed positives were reported as HAHA positive and titer was determined for each positive sample. The drug tolerance of the HAHA assay is 200 microgram/milliliter (µg/mL); thus, samples that tested negative in the assay and had ofatumumab concentrations no more than 200 µg/mL were considered as conclusive negative (Neg) results.
From the randomization date up to 60 months post the randomization date.
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
大体时间：From the randomization date up to 60 months post the randomization date.
The EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life (HRQoL) important in CLL. There are 4 multi-item scales - fatigue (2 items), treatment side effects ([TSE], 4 items), disease symptoms (disease effects scale [DES], 4 items), and infection (4 items) - and single item scales (social activities [Social Problems (SP) Scale] and future health worries[Future Health (FH) Scale].). These are measured on a four point scale where 1 = not at all and 4 = very much. These scores are transformed to give a rating from 0 - 100, where 0 =no symptoms or problems and 100 = a severe symptoms or problems. EORTC QLQ-CLL16 was assessed at Screening; Week (W) 12 (W4 of Cycle[C] 3), W24 (W4C6), W36 (W4C9), W48 (W4C13); during Follow-up which was every month for Months (M) 1-6, every 8 weeks for M7-12 and every 3 months up to M60; and then at PD.
From the randomization date up to 60 months post the randomization date.
Mean Health Change Questionnaire (HCQ) Score
大体时间：From the randomization date up to 60 months post the randomization date.
The HCQ consists of a single question in which the participant is asked if he/she has experienced any change in his/her health overall since beginning the study. For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for 'my health is a great deal better' to 9 for 'my health is a great deal worse' since the beginning of the study. A score of 3 or less indicates improvement from Baseline. HCQ was assessed at Screening; Week (W) 12 (W4 of Cycle[C] 3), W24 (W4C6), W36 (W4C9), W48 (W4C13); during follow-up which was every month for Months 1-6, every 8 weeks for M7-12 and every 3 months up to M60; and then at PD..
From the randomization date up to 60 months post the randomization date.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Novartis Pharmaceuticals

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2011年4月14日

初级完成 (实际的)

2014年3月18日

研究完成 (实际的)

2017年4月24日

研究注册日期

首次提交

2011年3月10日

首先提交符合 QC 标准的

2011年3月11日

首次发布 (估计)

2011年3月14日

研究记录更新

最后更新发布 (实际的)

2018年11月8日

上次提交的符合 QC 标准的更新

2018年10月9日

最后验证

2018年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 114242

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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