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Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis (TOPIC)

2017年1月20日 更新者：Sanofi

An International, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Year Treatment With Teriflunomide 7 mg Once Daily and 14 mg Once Daily Versus Placebo in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis Plus a Long Term Extension Period

The primary objective was to demonstrate the effect of teriflunomide (HMR1726) (14 milligram per day [mg/day] and 7 mg/day), in comparison to placebo, for reducing conversion of participants presenting with their first clinical episode consistent with multiple sclerosis (MS) to clinically definite multiple sclerosis (CDMS).

The secondary objectives were:

  • To demonstrate the effect of teriflunomide, in comparison to placebo, on:

    • Reducing conversion to definite multiple sclerosis (DMS)
    • Reducing annualized relapse rate (ARR)
    • Reducing disease activity/progression as measured by Magnetic Resonance Imaging (MRI)
    • Reducing accumulation of disability for at least 12 weeks as measured by the Expanded Disability Status Scale (EDSS)
    • Proportion of disability-free participants as assessed by the EDSS
    • Reducing participant-reported fatigue
  • To evaluate the safety and tolerability of teriflunomide
  • To evaluate the pharmacokinetics (PK) of teriflunomide
  • Optional pharmacogenomic testing aimed at assessing the association between the main enzyme systems of teriflunomide metabolism and hepatic safety, and other potential associations between gene variations and clinical outcomes

研究概览

地位

完全的

条件

干预/治疗

详细说明

The study consisted of 4 periods:

  • Screening period: up to 4 weeks,
  • Placebo-controlled treatment period: up to 108 weeks (at least 24 weeks for participants who experienced conversion to CDMS),
  • Extension treatment period (without placebo-control): the extension period continued until teriflunomide was commercially available in participant's country of residence.
  • Post-treatment washout period: 4 weeks after last treatment intake.

The maximal duration of the study period per participant was expected to be 116 weeks if he/she did not continue in the extension treatment period.

研究类型

介入性

注册 (实际的)

618

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

  • 丹麦
      • Aarhus C、丹麦、8000
        • Investigational Site Number 6002
      • Esbjerg、丹麦、6700
        • Investigational Site Number 6004
  • 乌克兰
      • Chernihiv、乌克兰、14029
        • Investigational Site Number 8507
      • Dnipropetrovsk、乌克兰、49027
        • Investigational Site Number 8501
      • Donets'K、乌克兰、83099
        • Investigational Site Number 8511
      • Kharkiv、乌克兰、61018
        • Investigational Site Number 8506
      • Kharkiv、乌克兰、61178
        • Investigational Site Number 8504
      • Kiev、乌克兰、03110
        • Investigational Site Number 8508
      • Lutsk、乌克兰、43005
        • Investigational Site Number 8512
      • Lviv、乌克兰、79010
        • Investigational Site Number 8505
      • Poltava、乌克兰、36011
        • Investigational Site Number 8510
      • Vinnytsya、乌克兰、21005
        • Investigational Site Number 8503
      • Zaporizhzhya、乌克兰、69000
        • Investigational Site Number 8502
  • 俄罗斯联邦
      • Kazan、俄罗斯联邦、420021
        • Investigational Site Number 7907
      • Nizhny Novgorod、俄罗斯联邦、603000
        • Investigational Site Number 7909
      • Nizhny Novgorod、俄罗斯联邦、603076
        • Investigational Site Number 7906
      • Nizhny Novgorod、俄罗斯联邦、603126
        • Investigational Site Number 7904
      • Novosibirsk、俄罗斯联邦、630007
        • Investigational Site Number 7912
      • Rostov-On-Don、俄罗斯联邦、344085
        • Investigational Site Number 7910
      • Smolensk、俄罗斯联邦、214019
        • Investigational Site Number 7905
      • St-Petersburg、俄罗斯联邦、194044
        • Investigational Site Number 7911
  • 保加利亚
      • Pleven、保加利亚、5800
        • Investigational Site Number 5312
      • Sofia、保加利亚、1000
        • Investigational Site Number 5307
      • Sofia、保加利亚、1407
        • Investigational Site Number 5304
      • Sofia、保加利亚、1431
        • Investigational Site Number 5309
      • Sofia、保加利亚、1527
        • Investigational Site Number 5303
      • Sofia、保加利亚、1606
        • Investigational Site Number 5306
  • 加拿大
      • Greenfield Park、加拿大、J4V 2J2
        • Investigational Site Number 5402
      • London、加拿大、N6A 5A5
        • Investigational Site Number 5403
      • Montreal、加拿大、H1T 2M4
        • Investigational Site Number 5409
      • Ottawa、加拿大、K1H 8L6
        • Investigational Site Number 5401
      • Quebec、加拿大、G1J 1Z4
        • Investigational Site Number 5406
      • Sherbrooke、加拿大、J1H 5N4
        • Investigational Site Number 5408
      • Toronto、加拿大、M4N 3M5
        • Investigational Site Number 5410
      • Toronto、加拿大、M5B 1W8
        • Investigational Site Number 5404
  • 匈牙利
      • Budapest、匈牙利、1076
        • Investigational Site Number 7101
      • Budapest、匈牙利、1145
        • Investigational Site Number 7103
      • Esztergom、匈牙利、2500
        • Investigational Site Number 7108
      • Veszprém、匈牙利、8200
        • Investigational Site Number 7105
  • 墨西哥
      • Chihuahua、墨西哥、31203
        • Investigational Site Number 7501
      • Guadalajara、墨西哥、45110
        • Investigational Site Number 7502
  • 奥地利
      • Innsbruck、奥地利、6020
        • Investigational Site Number 4004
      • Linz、奥地利、4020
        • Investigational Site Number 4005
      • Wien、奥地利、1010
        • Investigational Site Number 4001
  • 德国
      • Bayreuth、德国、95445
        • Investigational Site Number 6801
      • Berlin、德国、10713
        • Investigational Site Number 6810
      • Berlin、德国、10785
        • Investigational Site Number 6805
      • Erbach、德国、64711
        • Investigational Site Number 6807
      • Essen、德国、45122
        • Investigational Site Number 6803
      • Hannover、德国、30625
        • Investigational Site Number 6809
      • Ludwigshafen、德国、67063
        • Investigational Site Number 6804
      • Minden、德国、32429
        • Investigational Site Number 6815
      • Münster、德国、48149
        • Investigational Site Number 6802
      • Wiesbaden、德国、65191
        • Investigational Site Number 6806
  • 捷克共和国
      • Brno、捷克共和国、65691
        • Investigational Site Number 5801
      • Hradec Kralove、捷克共和国、50005
        • Investigational Site Number 5803
      • Olomouc、捷克共和国、77520
        • Investigational Site Number 5804
      • Ostrava - Poruba、捷克共和国、70852
        • Investigational Site Number 5805
  • 智利
      • Santiago、智利、760-0746
        • Investigational Site Number 5602
      • Santiago、智利
        • Investigational Site Number 5601
      • Santiago、智利
        • Investigational Site Number 5606
      • Viña Del Mar、智利、2520997
        • Investigational Site Number 5605
  • 法国
      • Besancon、法国、25030
        • Investigational Site Number 6611
      • Clermont Ferrand Cedex 1、法国、63003
        • Investigational Site Number 6601
      • Lille Cedex、法国、59037
        • Investigational Site Number 6609
      • Montpellier Cedex 05、法国、34295
        • Investigational Site Number 6604
      • Nancy Cedex、法国、54036
        • Investigational Site Number 6612
      • Nantes Cedex 01、法国、44093
        • Investigational Site Number 6605
      • Nice Cedex、法国、06002
        • Investigational Site Number 6602
      • Nimes、法国、30029
        • Investigational Site Number 6614
      • Strasbourg Cedex、法国、67091
        • Investigational Site Number 6607
  • 波兰
      • Gdansk、波兰、80-803
        • Investigational Site Number 7709
      • Lodz、波兰、93-513
        • Investigational Site Number 7710
      • Warszawa、波兰、02-097
        • Investigational Site Number 7701
      • Warszawa、波兰、02-957
        • Investigational Site Number 7703
      • Warszawa 44、波兰、04-141
        • Investigational Site Number 7707
  • 澳大利亚
      • Geelong、澳大利亚、3220
        • Investigational Site Number 1405
      • Heidelberg、澳大利亚、3081
        • Investigational Site Number 1404
      • Hobart、澳大利亚、7001
        • Investigational Site Number 1407
      • Parkville、澳大利亚、3050
        • Investigational Site Number 1401
  • 火鸡
      • Edirne、火鸡
        • Investigational Site Number 8304
      • Istanbul、火鸡、34390
        • Investigational Site Number 8309
      • Istanbul、火鸡、34400
        • Investigational Site Number 8315
      • Istanbul、火鸡
        • Investigational Site Number 8308
      • Istanbul、火鸡
        • Investigational Site Number 8310
      • Istanbul、火鸡
        • Investigational Site Number 8312
      • Izmir、火鸡、35100
        • Investigational Site Number 8305
      • Izmir、火鸡、35340
        • Investigational Site Number 8301
      • Izmir、火鸡、35380
        • Investigational Site Number 8303
      • Izmit、火鸡、41380
        • Investigational Site Number 8302
      • Trabzon、火鸡、61080
        • Investigational Site Number 8314
  • 爱沙尼亚
      • Tallinn、爱沙尼亚、10617
        • Investigational Site Number 6201
      • Tartu、爱沙尼亚、50406
        • Investigational Site Number 6203
  • 立陶宛
      • Klaipeda、立陶宛、LT-92288
        • Investigational Site Number 7402
      • Siauliai、立陶宛、LT-76231
        • Investigational Site Number 7403
      • Vilnius、立陶宛、LT-08661
        • Investigational Site Number 7401
  • 罗马尼亚
      • Bucuresti、罗马尼亚、020125
        • Investigational Site Number 7803
      • Bucuresti、罗马尼亚、050098
        • Investigational Site Number 7806
      • Cluj-Napoca、罗马尼亚、400012
        • Investigational Site Number 7805
      • Cluj-Napoca、罗马尼亚、400012
        • Investigational Site Number 7807
      • Timisoara、罗马尼亚、300736
        • Investigational Site Number 7808
  • 美国
    • Alabama
      • Cullman、Alabama、美国、35058
        • Investigational Site Number 8965
    • Arizona
      • Phoenix、Arizona、美国、85013-4496
        • Investigational Site Number 8954
      • Phoenix、Arizona、美国、85060
        • Investigational Site Number 8946
    • Colorado
      • Fort Collins、Colorado、美国、80528
        • Investigational Site Number 8962
    • Florida
      • Maitland、Florida、美国、32761
        • Investigational Site Number 8920
      • St. Petersburg、Florida、美国、33701
        • Investigational Site Number 8953
    • Indiana
      • Ft. Wayne、Indiana、美国、63104
        • Investigational Site Number 8914
      • Indianapolis、Indiana、美国、46256
        • Investigational Site Number 8940
    • Louisiana
      • Shreveport、Louisiana、美国、71103
        • Investigational Site Number 8922
    • Michigan
      • Grand Rapids、Michigan、美国、49503
        • Investigational Site Number 8955
      • Traverse City、Michigan、美国、49684
        • Investigational Site Number 8949
    • Missouri
      • St Louis、Missouri、美国、63104
        • Investigational Site Number 8937
    • New Mexico
      • Albuquerque、New Mexico、美国、87131
        • Investigational Site Number 8951
    • New York
      • New York、New York、美国、10029-6574
        • Investigational Site Number 8925
    • North Carolina
      • Charlotte、North Carolina、美国、28204
        • Investigational Site Number 8941
    • Ohio
      • Dayton、Ohio、美国、45409
        • Investigational Site Number 8924
    • Tennessee
      • Round Rock、Tennessee、美国、78681
        • Investigational Site Number 8905
    • Vermont
      • Burlington、Vermont、美国、05401
        • Investigational Site Number 8930
    • Washington
      • Seattle、Washington、美国、98122
        • Investigational Site Number 8963
  • 芬兰
      • Helsinki、芬兰、00100
        • Investigational Site Number 6405
      • Kuopio、芬兰、70210
        • Investigational Site Number 6403
      • Turku、芬兰、20100
        • Investigational Site Number 6401
  • 英国
      • Liverpool、英国、L9 7LJ
        • Investigational Site Number 8709
      • London、英国、E1 1BB
        • Investigational Site Number 8701
      • London、英国、SW17 0QT
        • Investigational Site Number 8704
      • Newcastle Upon Tyne、英国、NE1 4LP
        • Investigational Site Number 8706
      • Nottingham、英国、NG7 2UH
        • Investigational Site Number 8705
      • Plymouth、英国、PL6 5BX
        • Investigational Site Number 8708
      • Salford、英国、M6 8HD
        • Investigational Site Number 8707
      • Sheffield、英国、S10 2JF
        • Investigational Site Number 8702

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 至 55年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • First acute or subacute, well-defined neurological event consistent with demyelination (that is, optic neuritis confirmed by an ophthalmologist, spinal cord syndrome, brainstem/cerebellar syndromes)
  • Onset of MS symptoms occurring within 90 days of randomization
  • A screening MRI scan with 2 or more T2 lesions at least 3 millimeter (mm) in diameter that are characteristic of MS

Exclusion Criteria:

  • Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease
  • Significantly impaired bone marrow function
  • Pregnancy or nursing
  • Alcohol or drug abuse
  • Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment
  • Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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：双倍的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：Placebo/Teriflunomide 7 mg or Teriflunomide 14 mg

Core treatment period: Placebo matched to teriflunomide tablet once daily orally.

Extension treatment period: Re-randomized in 1:1 ratio to either teriflunomide 7 mg or 14 mg once daily orally.
药品：Teriflunomide
Film-coated tablet Oral administration
其他名称：
  • 奥巴焦
  • HMR1726
药品：Placebo
Film-coated tablet Oral administration
实验性的：Teriflunomide 7 mg/7 mg

Core treatment period: Teriflunomide 7 mg tablet once daily orally.

Extension treatment period: Teriflunomide 7 mg tablet once daily orally.
药品：Teriflunomide
Film-coated tablet Oral administration
其他名称：
  • 奥巴焦
  • HMR1726
实验性的：Teriflunomide 14 mg/14 mg

Core treatment period: Teriflunomide 14 mg tablet once daily orally.

Extension treatment period: Teriflunomide 14 mg tablet once daily orally.
药品：Teriflunomide
Film-coated tablet Oral administration
其他名称：
  • 奥巴焦
  • HMR1726

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
Core Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS)
大体时间：Up to a maximum of 108 weeks depending on time of enrollment
Conversion to CDMS was defined by the occurrence of a relapse, which was defined as a new neurological abnormality separated by at least 30 days from onset of a preceding clinical event, presented for at least 24 hours and occurred in the absence of fever or known infection. Percent probability of conversion at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.
Up to a maximum of 108 weeks depending on time of enrollment

次要结果测量

结果测量
措施说明
大体时间
Core Treatment Period: Time to Conversion to Definite Multiple Sclerosis (DMS)
大体时间：Up to a maximum of 108 weeks depending on time of enrollment
Conversion to DMS was demonstrated by dissemination of MRI lesions in time (as per McDonald criteria) or a relapse, whichever occurs first. MRI Imaging criteria were detection of Gadolinium (Gd) enhancement at least 3 months after onset of initial clinical event, if not at site corresponding to initial event; detection of new T2 lesion if it appears at any time compared with reference scan (done at time of screening) done at least 30 days after onset of the initial clinical event. Occurrence of relapse was defined as new neurological abnormality separated by at least 30 days from onset of preceding clinical event, present for at least 24 hours and occurring in absence of fever or known infection. New clinical abnormality (neurological sign) that is consistent with participant's symptoms with increase in at least one Functional System (FS) or EDSS score compared to last EDSS assessment. Percent probability of conversion at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.
Up to a maximum of 108 weeks depending on time of enrollment
Core Treatment Period: Annualized Relapse Rate (ARR)
大体时间：Up to a maximum of 108 weeks depending on time of enrollment
ARR is the total number of confirmed relapses that occurred during the treatment period divided by the total number of patient-years treated. Each episode of relapse (appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever) was to be confirmed by an increase in EDSS score or Functional System scores. ARR was assessed using Poisson regression model with robust error variance. To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses onset between randomization date and last dose date as the response variable, treatment, region and baseline monofocal/multifocal status as covariates, and log-transformed treatment duration as an offset variable).
Up to a maximum of 108 weeks depending on time of enrollment
Core Treatment Period: Brain Magnetic Resonance Imaging (MRI) Assessment: Change From Baseline in Total Lesion Volume at Week 108
大体时间：Baseline, Week 108
The total lesion volume (burden of disease) is the total volumes of hyperintense on T2 plus hypointense on T1 as measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data with factors for treatment, baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline burden of disease, and baseline-by-visit interaction.
Baseline, Week 108
Core Treatment Period: Brain MRI Assessment: Number of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per MRI Scan (Poisson Regression Estimates)
大体时间：Up to a maximum of 108 weeks depending on time of enrollment
Number of Gd-enhancing T1-lesions per scan is the total number of Gd-enhancing T1-lesions that occurred during the treatment period divided by the total number of scans performed during the treatment period. To account for the different numbers of scans performed among the participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable, treatment, baseline monofocal/multifocal status, region and baseline number of Gd-enhancing T1-lesions as covariates, and log-transformed number of scans as an offset variable).
Up to a maximum of 108 weeks depending on time of enrollment
Core Treatment Period: Brain MRI Assessment: Volume of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per MRI Scan
大体时间：Up to a maximum of 108 weeks depending on time of enrollment
Total volume of Gd-enhancing T1-lesions per scan is the sum of the volumes of Gd-enhancing T1-lesions observed during the treatment period divided by the total number of scans performed during the treatment period. To account for the different numbers of scans performed among the participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable, treatment, baseline monofocal/multifocal status, region and baseline number of Gd-enhancing T1-lesions as covariates, and log-transformed number of scans as an offset variable).
Up to a maximum of 108 weeks depending on time of enrollment
Core Treatment Period: Brain MRI Assessment: Change From Baseline in Volume of Hypointense Post-Gadolinium T1 Lesion Component
大体时间：Baseline, Week 108
Volume of hypointense post-gadolinium T1 lesion component was measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline value, and baseline-by-visit interaction
Baseline, Week 108
Core Treatment Period: Brain MRI Assessment: Change From Baseline in Volume of T2 Lesion Component
大体时间：Baseline, Week 108
Volume of T2 lesion component was measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline value, and baseline-by-visit interaction.
Baseline, Week 108
Core Treatment Period: Brain MRI Assessment: Percent Change From Baseline in Atrophy
大体时间：Baseline, Week 108
Atrophy was measured by MRI scan.
Baseline, Week 108
Core Treatment Period: Time to 12-Week Sustained Disability Progression
大体时间：Up to a maximum of 108 weeks depending on time of enrollment
The 12-week sustained disability progression was defined as increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score of greater than [>] 5.5) that persisted for at least 12 weeks. Percent probability of participants free of 12-week sustained disability progression at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.
Up to a maximum of 108 weeks depending on time of enrollment
Core Treatment Period: Change From Baseline in EDSS at Week 108
大体时间：Baseline, Week 108
EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, baseline value and baseline-by-visit interaction
Baseline, Week 108
Core Treatment Period: Change From Baseline in Fatigue Impact Scale (FIS) Total Score at Week 108
大体时间：Baseline, Week 108
FIS is a participant-reported scale that qualifies the impact of fatigue on daily life in participants with MS. It consists of 40 statements that measure fatigue in three areas; physical, cognitive, and social. FIS total score ranges from 0 (no problem) to 160 (extreme problem). Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on FIS total score data adjusted for or baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, baseline value and baseline-by-visit interaction.
Baseline, Week 108
Core Treatment Period: Overview of Adverse Events (AEs)
大体时间：From first study drug intake up to 112 days after last intake in the placebo-controlled period or up to first intake in the extension treatment period, whichever occurred first
AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.
From first study drug intake up to 112 days after last intake in the placebo-controlled period or up to first intake in the extension treatment period, whichever occurred first
Extension Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS)
大体时间：From randomization in the core period up to 390 Weeks (Extension treatment period [maximum exposure: 283 Weeks])
Conversion to CDMS was defined by the occurrence of a relapse, which was defined as a new neurological abnormality separated by at least 30 days from onset of a preceding clinical event, presented for at least 24 hours and occurred in the absence of fever or known infection. Percent probability of conversion was estimated using Kaplan-Meier method.
From randomization in the core period up to 390 Weeks (Extension treatment period [maximum exposure: 283 Weeks])
Extension Treatment Period: Overview of Adverse Events (AEs)
大体时间：From re-randomization up to 283 Weeks
AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study. Safety population included all randomized population who actually received at least 1 dose of the IMP in extension and analyzed according to the treatment actually received in core study followed by treatment actually received in the extension treatment period.
From re-randomization up to 283 Weeks

其他结果措施

结果测量
措施说明
大体时间
Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)
大体时间：From first study drug intake up to 112 days after last intake in the placebo-controlled period or up to first intake in the extension treatment period, whichever occurred first

PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.

Hepatic parameters thresholds were defined as follows:

  • Alanine Aminotransferase (ALT) >3, 5, 10 or 20 upper limit of normal(ULN);
  • Aspartate aminotransferase (AST) >3, 5, 10 or 20 ULN;
  • Alkaline Phosphatase >1.5 ULN;
  • Total Bilirubin (TB) >1.5, 2, or 3 ULN;
  • ALT >3 ULN and TB >2 ULN.
From first study drug intake up to 112 days after last intake in the placebo-controlled period or up to first intake in the extension treatment period, whichever occurred first

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

Sanofi

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

2008年2月1日

初级完成 (实际的)

2012年12月1日

研究完成 (实际的)

2016年2月1日

研究注册日期

首次提交

2008年2月14日

首先提交符合 QC 标准的

2008年2月22日

首次发布 (估计)

2008年2月25日

研究记录更新

最后更新发布 (实际的)

2017年3月13日

上次提交的符合 QC 标准的更新

2017年1月20日

最后验证

2017年1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

  • EFC6260
  • HMR1726D-3005 (其他标识符：HMR)
  • 2006-001152-12 (EudraCT编号)

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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