C型肝炎(Hepatitis C):世界の治験レビュー(2014年下半期版)

◆英語タイトル:Hepatitis C Global Clinical Trials Review, H2, 2014
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◆発行日:2014年11月28日
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当調査レポートでは、世界におけるC型肝炎(Hepatitis C) 治療の臨床試験動向について調査・分析し、アジア太平洋/欧州/北米/中南米の主要国における治験件数、段階(フェーズ)別の治験件数、進捗状況別の治験件数、治験目標の達成状況、有望な薬剤、治験関連の最新ニュース、代表的な企業・大学・研究機関における治験概要、代表的な治験のプロファイルなどのデータをまとめてお届けいたします。

・イントロダクション
  - C型肝炎(Hepatitis C)
  - 当レポートの概要
・C型肝炎(Hepatitis C):各地域別治験状況
  - 各国の治験件数及び平均被験者数
   アジア太平洋の主要国における治験件数
   欧州の主要国における治験件数
   北米の主要国における治験件数
   中東・アフリカの主要国における治験件数
   中南米の主要国における治験件数
・G7諸国での治験件数
・G7諸国での治験件数:段階別
・G7諸国での治験件数:進捗状況別
・段階(フェーズ)別の治験件数:進行中の治験(段階別)
・進捗状況別の治験件数
・治験目標の達成状況
・未完了の治験件数
・一定期間に採用された被験者
・スポンサーの種類別治験件数
・有望なスポンサー
・有望な薬剤
・治験のプロファイル
  - 代表的な企業における治験概要
  - 代表的な大学・研究機関における治験概要
・5つの代表的な治験のプロファイル
【レポートの概要】

Hepatitis C Global Clinical Trials Review, H2, 2014

Summary

GlobalData’s clinical trial report, “Hepatitis C Global Clinical Trials Review, H2, 2014″ provides data on the Hepatitis C clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Hepatitis C. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Hepatitis C. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData’s team of industry experts.

Note: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.

Scope

- Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each
- Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type
- Listings of discontinued trials (suspended, withdrawn and terminated)

Reasons to buy

- Understand the dynamics of a particular indication in a condensed manner
- Abridged view of the performance of the trials in terms of their status, recruitment, location, sponsor type and many more
- Obtain discontinued trial listing for trials across the globe
- Espy the commercial landscape of the major Universities / Institutes / Hospitals or Companies

【レポートの目次】

Table of Contents
Table of Contents 2
List of Tables 5
List of Figures 6
Introduction 7
Hepatitis C 7
Report Guidance 7
Clinical Trials by Region 8
Clinical Trials and Average Enrollment by Country 9
Top Five Countries Contributing to Clinical Trials in Asia-Pacific 11
Top Five Countries Contributing to Clinical Trials in Europe 12
Top Countries Contributing to Clinical Trials in North America 13
Top Five Countries Contributing to Clinical Trials in Middle East and Africa 14
Top Five Countries Contributing to Clinical Trials in Central and South America 15
Clinical Trials by G7 Countries: Proportion of Hepatitis C to Infectious Disease Clinical Trials 16
Clinical Trials by Phase in G7 Countries 17
Clinical Trials in G7 Countries by Trial Status 18
Clinical Trials by E7 Countries: Proportion of Hepatitis C to Infectious Disease Clinical Trials 19
Clinical Trials by Phase in E7 Countries 20
Clinical Trials in E7 Countries by Trial Status 21
Clinical Trials by Phase 22
In Progress Trials by Phase 23
Clinical Trials by Trial Status 24
Clinical Trials by End Point Status 25
Unaccomplished Trials of Hepatitis C 26
Subjects Recruited Over a Period of Time 41
Clinical Trials by Sponsor Type 42
Prominent Sponsors 43
Top Companies Participating in Hepatitis C Therapeutics Clinical Trials 44
Prominent Drugs 46
Latest Clinical Trials News on Hepatitis C 47
Nov 11, 2014: Gilead Announces Harvoni Study Results in Chronic Hepatitis C Patients with Advanced Liver Disease and Those Who Failed Prior Treatment 47
Nov 11, 2014: Gilead Announces Phase 2 Data for Investigational All-Oral Regimen of Sofosbuvir Plus GS-5816 for the Treatment of Chronic Hepatitis C 48
Nov 11, 2014: Merck Announces Results from Phase 2 Study of Investigational Chronic Hepatitis C Treatment Grazoprevir/Elbasvir in Genotype 1 Infected Treatment-Naïve and Difficult-to-Cure Patients 48
Nov 11, 2014: Enanta Announces Results From Phase 2b PEARL-I Study In Genotype 4 Chronic Hepatitis C Patients At The Liver Meeting 2014 50
Nov 11, 2014: AbbVie to Present Results from Studies in Chronic Hepatitis C Patients with HIV-1 Co-Infection (TURQUOISE-I) and Liver Transplant Recipients (CORAL-I) at The Liver Meeting 2014 51
Nov 11, 2014: AbbVie to Present Results from Phase 2 PEARL-I Study in Genotype 4 Chronic Hepatitis C Patients at The Liver Meeting 2014 52
Nov 10, 2014: Very good results of Civacir (Hepatitis C Immune Globulin) US Phase III clinical trial 53
Nov 08, 2014: ALLY Trial Demonstrates High Cure Rates for Investigational Daclatasvir and Sofosbuvir Combination among Genotype 3 Hepatitis C Patients 53
Nov 08, 2014: Phase 3 UNITY Trials Demonstrate High Cure Rates for Investigational, All-Oral Daclatasvir TRIO Fixed-Dose Combination in Genotype 1 Hepatitis C Patients, Including Those with Cirrhosis 54
Nov 08, 2014: Achillion Reports 100% SVR12 in a Phase 2 Combination Study With ACH-3102 at the Liver Meeting 2014 (AASLD) 55
Nov 08, 2014: Achillion Reports Data in Three Preclinical Posters on ACH-3422 at the Liver Meeting 2014 (AASLD) 55
Nov 06, 2014: Alios BioPharma to Present Preclinical Data on its Anti-HCV Nucleotides AL-335 56
Nov 06, 2014: Alios BioPharma to Present Preclinical Data on its Anti-HCV Nucleotides AL-516 56
Nov 05, 2014: New vaccine generates strong immune response against hepatitis C 57
Nov 03, 2014: Theravance Biopharma Announces Positive Results From Phase 1 Proof-of-Concept Study of TD-6450, an NS5A Inhibitor to Treat Hepatitis C 58
Oct 22, 2014: A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus’ Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment History 59
Oct 10, 2014: BIT225 Trial Results Show Effective Cure Of Hepatitis C 60
Oct 10, 2014: Phase II IMPACT study initiated to evaluate Simeprevir in combination with Sofosbuvir and Daclatasvir to treat genotype 1 and 4 hepatitis C patients 61
Oct 08, 2014: Achillion To Present Updated Clinical HCV Data On ACH-3102 At The American Association For The Study Of Liver Diseases (AASLD) Annual Meeting 62
Oct 08, 2014: TT-­034 HCV Trial Update 62
Oct 07, 2014: Immunotech Laboratories Updates Progress on Negotiations for Phase III Testing on its Treatments for HIV/AIDS and Hepatitis C Viruses in Macedonia and Serbia 63
Sep 24, 2014: Gilead Submits New Drug Application to Japan’s Pharmaceutical and Medical Devices Agency for Fixed-Dose Combination of Ledipasvir/Sofosbuvir for Chronic Hepatitis C Genotype 1 Infection 63
Sep 15, 2014: Alios BioPharma Presents Data on its Anti-HCV Nucleotide AL-335 at Special Conference on Hepatitis C 64
Sep 10, 2014: Enanta Pharmaceuticals Announces the Initiation of Phase 2b Clinical Trial with Regimen Containing HCV Protease Inhibitor ABT-493 64
Aug 28, 2014: Immunotech Laboratories Announces Successful Completion of Phase I and Phase II Field Trials of the Company’s Patented Treatment of the HIV/AIDS and Hepatitis C Viruses 65
Clinical Trial Profiles 66
Clinical Trial Overview of Top Companies 66
Merck & Co., Inc. 66
Clinical Trial Overview of Merck & Co., Inc. 66
F. Hoffmann-La Roche Ltd. 82
Clinical Trial Overview of F. Hoffmann-La Roche Ltd. 82
Gilead Sciences, Inc. 99
Clinical Trial Overview of Gilead Sciences, Inc. 99
Bristol-Myers Squibb Company 107
Clinical Trial Overview of Bristol-Myers Squibb Company 107
Vertex Pharmaceuticals Incorporated 114
Clinical Trial Overview of Vertex Pharmaceuticals Incorporated 114
Johnson & Johnson 120
Clinical Trial Overview of Johnson & Johnson 120
C. H. Boehringer Sohn AG & Co. KG 128
Clinical Trial Overview of C. H. Boehringer Sohn AG & Co. KG 128
AbbVie Inc. 133
Clinical Trial Overview of AbbVie Inc. 133
Novartis AG 139
Clinical Trial Overview of Novartis AG 139
GlaxoSmithKline plc 143
Clinical Trial Overview of GlaxoSmithKline plc 143
Clinical Trial Overview of Top Institutes / Government 146
The National Institute of Allergy and Infectious Diseases 146
Clinical Trial Overview of The National Institute of Allergy and Infectious Diseases 146
French National Agency for Research on AIDS and Viral Hepatitis 149
Clinical Trial Overview of French National Agency for Research on AIDS and Viral Hepatitis 149
The National Institute of Diabetes and Digestive and Kidney Diseases 152
Clinical Trial Overview of The National Institute of Diabetes and Digestive and Kidney Diseases 152
National Taiwan University Hospital 154
Clinical Trial Overview of National Taiwan University Hospital 154
U.S. Department of Veterans Affairs 156
Clinical Trial Overview of U.S. Department of Veterans Affairs 156
Kaohsiung Medical University Chung-Ho Memorial Hospital 157
Clinical Trial Overview of Kaohsiung Medical University Chung-Ho Memorial Hospital 157
Kyushu University 158
Clinical Trial Overview of Kyushu University 158
University Health Network 159
Clinical Trial Overview of University Health Network 159
Medical University of Vienna 160
Clinical Trial Overview of Medical University of Vienna 160
Osaka University 161
Clinical Trial Overview of Osaka University 161
Five Key Clinical Profiles 162
Appendix 212
Abbreviations 212
Definitions 212
Research Methodology 213
Secondary Research 213
About GlobalData 214
Contact Us 214
Disclaimer 214
Source 214

List of Tables
Hepatitis C Therapeutics, Global, Clinical Trials by Region, 2014* 8
Hepatitis C Therapeutics, Global, Clinical Trials and Average Enrollment by Top Countries, 2014* 9
Hepatitis C Therapeutics, Global, Clinical Trials In Progress by Top Countries, 2014* 10
Hepatitis C Therapeutics Clinical Trials, Asia-Pacific, Top Five Countries, 2014* 11
Hepatitis C Therapeutics Clinical Trials, Europe, Top Five Countries, 2014* 12
Hepatitis C Therapeutics Clinical Trials, North America, Top Countries, 2014* 13
Hepatitis C Therapeutics Clinical Trials, Middle East and Africa, Top Five Countries, 2014* 14
Hepatitis C Therapeutics Clinical Trials, Central and South America, Top Five Countries, 2014* 15
Proportion of Hepatitis C to Infectious Disease Clinical Trials, G7 Countries (%), 2014* 16
Hepatitis C Therapeutics, G7 Countries, Clinical Trials by Phase, 2014* 17
Hepatitis C Therapeutics, G7 Countries, Clinical Trials by Trial Status, 2014* 18
Proportion of Hepatitis C to Infectious Disease Clinical Trials, E7 Countries (%), 2014* 19
Hepatitis C Therapeutics, E7 Countries, Clinical Trials by Phase, 2014* 20
Hepatitis C Therapeutics, E7 Countries, Clinical Trials by Trial Status, 2014* 21
Hepatitis C Therapeutics, Global, Clinical Trials by Phase, 2014* 22
Hepatitis C Therapeutics, Global, Clinical Trials In Progress by Phase 2014* 23
Hepatitis C Therapeutics, Global, Clinical Trials by Trial Status, 2014* 24
Hepatitis C Therapeutics Clinical Trials, Global, by End Point Status, 2014* 25
Hepatitis C Therapeutics, Global, Suspended Clinical Trials, 2014* 26
Hepatitis C Therapeutics, Global, Withdrawn Clinical Trials, 2014* 27
Hepatitis C Therapeutics, Global, Terminated Clinical Trials, 2014* 31
Hepatitis C Therapeutics Clinical Trials, Global, Average Enrollment Target Trends, 2009-2013 41
Hepatitis C Therapeutics Market, Global, Clinical Trials by Sponsor Type, 2014* 42
Hepatitis C Therapeutics Clinical Trials, Global, Key Sponsors, 2014* 43
Hepatitis C Therapeutics Clinical Trials, Global, Top Companies by Phase, 2014* 45
Hepatitis C Therapeutics Clinical Trials, Global, Ongoing Clinical Trials by Prominent Drugs, 2014* 46
Hepatitis C Therapeutics Clinical Trials Market, Global, Clinical Trials by Merck & Co., Inc., 2014* 66
Hepatitis C Therapeutics Clinical Trials Market, Global, Clinical Trials by F. Hoffmann-La Roche Ltd., 2014* 82
Hepatitis C Therapeutics Clinical Trials Market, Global, Clinical Trials by Gilead Sciences, Inc., 2014* 99
Hepatitis C Therapeutics Clinical Trials Market, Global, Clinical Trials by Bristol-Myers Squibb Company, 2014* 107
Hepatitis C Therapeutics Clinical Trials Market, Global, Clinical Trials by Vertex Pharmaceuticals Incorporated, 2014* 114
Hepatitis C Therapeutics Clinical Trials Market, Global, Clinical Trials by Johnson & Johnson, 2014* 120
Hepatitis C Therapeutics Clinical Trials Market, Global, Clinical Trials by C. H. Boehringer Sohn AG & Co. KG, 2014* 128
Hepatitis C Therapeutics Clinical Trials Market, Global, Clinical Trials by AbbVie Inc., 2014* 133
Hepatitis C Therapeutics Clinical Trials Market, Global, Clinical Trials by Novartis AG, 2014* 139
Hepatitis C Therapeutics Clinical Trials Market, Global, Clinical Trials by GlaxoSmithKline plc, 2014* 143
Hepatitis C Therapeutics Clinical Trials Market, Global, Clinical Trials by The National Institute of Allergy and Infectious Diseases, 2014* 146
Hepatitis C Therapeutics Clinical Trials Market, Global, Clinical Trials by French National Agency for Research on AIDS and Viral Hepatitis, 2014* 149
Hepatitis C Therapeutics Clinical Trials Market, Global, Clinical Trials by The National Institute of Diabetes and Digestive and Kidney Diseases, 2014* 152
Hepatitis C Therapeutics Clinical Trials Market, Global, Clinical Trials by National Taiwan University Hospital, 2014* 154
Hepatitis C Therapeutics Clinical Trials Market, Global, Clinical Trials by U.S. Department of Veterans Affairs, 2014* 156
Hepatitis C Therapeutics Clinical Trials Market, Global, Clinical Trials by Kaohsiung Medical University Chung-Ho Memorial Hospital, 2014* 157
Hepatitis C Therapeutics Clinical Trials Market, Global, Clinical Trials by Kyushu University, 2014* 158
Hepatitis C Therapeutics Clinical Trials Market, Global, Clinical Trials by University Health Network, 2014* 159
Hepatitis C Therapeutics Clinical Trials Market, Global, Clinical Trials by Medical University of Vienna, 2014* 160
Hepatitis C Therapeutics Clinical Trials Market, Global, Clinical Trials by Osaka University, 2014* 161

List of Figures
Hepatitis C Therapeutics, Global, Clinical Trials by Region (%), 2014* 8
Hepatitis C Therapeutics, Global, Clinical Trials and Average Enrollment by Top Countries, 2014* 9
Hepatitis C Therapeutics, Global, Clinical Trials In Progress by Top Countries, 2014* 10
Hepatitis C Therapeutics Clinical Trials, Asia-Pacific, Top Five Countries (%), 2014* 11
Hepatitis C Therapeutics Clinical Trials, Europe, Top Five Countries (%), 2014* 12
Hepatitis C Therapeutics Clinical Trials, North America, Top Countries (%), 2014* 13
Hepatitis C Therapeutics Clinical Trials, Middle East and Africa, Top Five Countries (%), 2014* 14
Hepatitis C Therapeutics Clinical Trials, Central and South America, Top Five Countries (%), 2014* 15
Proportion of Hepatitis C to Infectious Disease Clinical Trials, G7 Countries (%), 2014* 16
Hepatitis C Therapeutics, G7 Countries, Clinical Trials by Phase, 2014* 17
Hepatitis C Therapeutics, G7 Countries, Clinical Trials by Trial Status, 2014* 18
Proportion of Hepatitis C to Infectious Disease Clinical Trials, E7 Countries (%), 2014* 19
Hepatitis C Therapeutics, E7 Countries, Clinical Trials by Phase, 2014* 20
Hepatitis C Therapeutics, E7 Countries, Clinical Trials by Trial Status, 2014* 21
Hepatitis C Therapeutics, Global, Clinical Trials by Phase (%), 2014* 22
Hepatitis C Therapeutics, Global, Clinical Trials In Progress by Phase, 2014* 23
Hepatitis C Therapeutics, Global, Clinical Trials by Trial Status, 2014* 24
Hepatitis C Therapeutics Clinical Trials, Global, by End Point Status, 2014* 25
Hepatitis C Therapeutics Clinical Trials, Global, Average Enrollment Target Trends, 2009-2013 41
Hepatitis C Therapeutics Market, Global, Clinical Trials by Sponsor Type (%), 2014* 42
Hepatitis C Therapeutics Clinical Trials, Global, Key Sponsors, 2014* 43
Hepatitis C Therapeutics Clinical Trials, Global, Top Companies by Phase, 2014* 44
Hepatitis C Therapeutics Clinical Trials, Global, Ongoing Clinical Trials by Prominent Drugs, 2014* 46
GlobalData Methodology 213

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