IPF患者服用BIBF1120的长期安全性的延长期试验

1
查找项目通过临床招募信息库查项目

2
联系我们招募专员进行初筛

3
签署同意签署知情同意书

4
成功入组成功参加临床试验

试验详情
入选标准
排除标准
研究中心

试验详情

一、临床试验项目名称
IPF患者服用BIBF1120的长期安全性的延长期试验

二、适应症
特发性肺纤维化

三、试验介绍

本扩展试验的目的是向所有在双盲Ⅲ期安慰剂对照母试验（1199.32 和 1199.34）中完
成一年治疗期和随访期，并且可能受益于研究药物并希望接受治疗的患者提供BIBF 1120
治疗。

研究中心所在省份及城市（具体启动情况以后期咨询为准）

研究中心	主要研究者
中国医学科学院北京协和医院	徐作军教授

序号	机构名称	主要研究者	国家	省（州）	城市
1	中国医学科学院北京协和医院	徐作军	中国	北京	北京
2	北京大学人民医院	高占成	中国	北京	北京
3	南昌大学第一附属医院	张伟	中国	江西	南昌
4	四川大学华西医院	文富强	中国	四川	成都
5	中南大学湘雅医院	肖奇明	中国	湖南	长沙
6	第四军医大学第一附属医院（西京医院）	李志奎	中国	陕西	西安
7	上海市肺科医院	李惠萍	中国	上海	上海
8	沈阳军区总医院	陈萍	中国	辽宁	沈阳
9	复旦大学附属中山医院	白春学	中国	上海	上海
10	首都医科大学附属北京友谊医院	王浩彦	中国	北京	北京
11	宁夏医科大学总医院	郑西卫	中国	宁夏	银川
12	Royal Prince Alfred Hospital	Tamera Corte	Australia	NSW	Camperdown
13	Repatriation General Hospital	Elizabeth Veitch	Australia	NSW	Concord
14	Alfred Hospital	Ian Glaspole	Australia	VIC	Melbourne
15	Frankston Hospital	Juan Mulder	Australia	VIC	Frankston
16	UZ Leuven	Wim Wuyts	Belgium	N/A	Leuven
17	Cliniques universitaires de Mont-Godinne	Yves Sibille	Belgium	N/A	Yvoir
18	Hopital Universitaire Erasme	Paul De Vuyst	Belgium	N/A	Bruxelles
19	UZ Brussel	Walter Vincken	Belgium	N/A	Brussel
20	Diagnostics Research Group	Charles Andrews	United States of America	TX	San Antonio
21	Lynchburg Pulmonary Associates	Albert Baker	United States of America	VA	Lynchburg
22	Pulmonary Associates Clinical Trials	Mark Gotfried	United States of America	AZ	Phoenix
23	Oregon Clinic, PC	David Hotchkin	United States of America	OR	Portland
24	Minnesota Lung Center, Ltd	Mitchell Kaye	United States of America	MN	Minneapolis
25	Western Connecticut Medical Group, PC	David Oelberg	United States of America	CT	Danbury
26	UCLA David Geffen School of Medicine	John Belperio	United States of America	CA	Torrance
27	Baptist Pulmonary and Critical Care Associates	John Thompson	United States of America	KY	Lexington
28	Jamaica Hospital Medical Center	Craig Thurm	United States of America	NY	Jamaica
29	ID Clinical Research Ltd	James Tita	United States of America	OH	Toledo
30	Jasper Summit Research, LLC	Jan Westerman	United States of America	AL	Jasper
31	Cardiopulmonary Associates	Neil Ettinger	United States of America	MO	Chesterfield
32	Inova Fairfax Hospital	Steven Nathan	United States of America	VA	Falls Church
33	Georgia Clinical Research	Amy Hajari Case	United States of America	GA	Austell
34	FDC Seifer PLC Pulmonary	Frederic Seifer	United States of America	TN	Shelbyville
35	Pulmonary Associates of Stamford	Paul Sachs	United States of America	CT	Stamford
36	DCOL Center for Clinical Research	Jeffrey Shea	United States of America	TX	Longview
37	Metroplex Pulmonary and Sleep Center	Shahrukh Kureishy	United States of America	TX	McKinney
38	New York Presbyterian Hospital	David Lederer	United States of America	NY	New York
39	Via Christi Clinic, PA	Mark Wencel	United States of America	KS	Wichita
40	Medical University of South Carolina	John Terrill Huggins	United States of America	SC	Charleston
41	Sansum Clinic	Charles Schroeder	United States of America	CA	Santa Barbara
42	Dartmouth-Hitchcock Medical Center	Richard Enelow	United States of America	NH	Lebanon
43	University of Cincinnati Medical Center	Robert Baughman	United States of America	OH	Cincinnati
44	David Geffen School of Medicine at University of California	John Belperio	United States of America	CA	Los Angeles
45	The University of California, San Francisco	Jeffrey Golden	United States of America	CA	San Francisco
46	Rhode Island Hospital	Kevin Dushay	United States of America	RI	Providence
47	University of Pittsburgh School of Medicine	Kevin Gibson	United States of America	PA	Pittsburgh
48	Vanderbilt University Medical Center	Lisa Lancaster	United States of America	TN	Nashville
49	Vermont Lung Center at the University of Vermont	Yolanda Mageto	United States of America	VT	Colchester
50	Stanford University Medical Center	Paul Mohabir	United States of America	CA	Stanford
51	Cleveland Clinic Florida	Frank Rahaghi	United States of America	FL	Weston
52	University of Chicago	Imre Noth	United States of America	IL	Chicago
53	Hospital of the University of Pennsylvania	Milton Rossman	United States of America	PA	Philadelphia
54	Pulmonary and Critical Care Associates	Jamie Masson	United States of America	NY	Albany
55	UT Southwestern Medical Center	Corey Kershaw	United States of America	TX	Dallas
56	University of Wisconsin Hospital and Clinics	Keith Meyer	United States of America	WI	Madison
57	St. Joseph's Healthcare	Martin Kolb	Canada	ON	Hamilton
58	QE II Health Sciences Centre	Paul Hernandez	Canada	NS	Halifax
59	Universitaetsklinikum Essen	Ulrich Costabel	Germany	无	Essen
60	Universitaetsklinikum Freiburg	Joachim Mueller-Quernheim	Germany	无	Freiburg/Breisgau
61	Pneumologisches Forschunginstitut	Anne-Marie Kirsten	Germany	无	Grosshansdorf
62	Universitaetsklinikum der Johannes Gutenberg	Stephanie Korn	Germany	无	Mainz
63	Klinikum Donaustauf	Stefan Blaas	Germany	无	Donaustauf
64	Universitaetsklinikum Giessen und Marburg GmbH	Andreas Guenther	Germany	无	Giessen
65	Universitaetsklinikum Heidelberg	Michael Kreuter	Germany	无	Heidelberg
66	Lungenaerztliche Gemeinschaftspraxis	Joachim Kirschner	Germany	无	Bamberg
67	HELIOS-Kliniken Emil von Behring	Nicolas Schoenfeld	Germany	无	Berlin
68	Fachkrankenhaus Coswig GmbH	DirkKoschel	Germany	无	Coswig
69	Klinikum Grosshadern der LMU Muenchen	Claus Neurohr	Germany	无	Muenchen
70	Universitaetsmedizin Greifswald	Sven Glaeser	Germany	无	Greifswald
71	Lungenfachklinik Immenhausen	Peter Hammerl	Germany	无	Immenhausen
72	Evangelische Lungenklinik Berlin	Christian Grohe	Germany	无	Berlin-Buch
73	Universitaetsklinikum Muenster	Rainer Wiewrodt	Germany	无	Muenster
74	Hospital Vall d′Hebron	Ferraen Morell	Spain	Spain	Barcelona
75	Hospital Clinic i Provincial de Barcelona	Antoni Xaubet	Spain	Spain	Barcelona
76	Ciutat Sanitaria Universitaria de Bellvitge	Maria Molina-Molina	Spain	Spain	L′Hospitalet de Llobregat
77	Hospital Nuestra Seneora de Valme	Inmaculada Alfageme Michavila	Spain	Spain	Sevilla
78	Hospital Bichat	Bruno Crestani	France	无	Paris
79	Hospital Avicenne	Dominique Valeyre	France	无	BOBIGNY Cedex
80	Hospital Pasteur	Charles Hugo Marquette	France	无	Nice Cedex 1
81	CHRU Pontchaillou	Stéphane Jouneau	France	无	Rennes Cedex 9
82	Hospital Tenon	Jacques Cadranel	France	无	Paris Cedex 20
83	Hospital Europeen Georges Pompidou	Dominique Israel-Biet	France	无	Paris
84	Hospital Maison Blanche	Francois Lebargy	France	无	Reims Cedex
85	Hospital Arnaud de Villeneuve	Arnaud Bourdin	France	无	Montpellier Cedex 5
86	Hospital Albert Calmette	Benoit Wallaert	France	无	Lille Cedex
87	Hospital du Bocage	Philippe Camus	France	无	Dijon
88	Hospital Louis Pradel	Vincent Cottin	France	无	Lyon cedex
89	Hospital Larrey	Grégoire Prevot	France	无	Toulouse Cedex 9
90	Hospital Nord	Pascal Chanez	France	无	Marseille
91	University Hospital of Heraklion	Nicolaos Siafakas	Greece	无	Heraklion
92	University Hospital of Larisa	Zoe Daniil	Greece	无	Larisa
93	Athens Hospital of Chest Diseases	Nikolaos Koulouris	Greece	无	Athens
94	National Allergy Asthma Bronchitis Institute, Kolkata	Alok Gopal Ghoshal	India	MAHARASHTR	Mumbai
95	SMS Medical College and HospitaL	Virendra Singh	India	无	Kolkatta
96	Mehta Hospital & Cardiopulmonary Care Centre	Parthiv Mehta	India	无	Jaipur
97	Chest & Maternity Center	Sathish Shivappa Kadappa	India	GUJARAT	Ahmedabad
98	Jehangir Clinical Development Centre Pvt Ltd	Mahendra Kawedia	India	无	Bangalore
99	Asthma Bhawan	Ashish Kumar	India	无	Pune
100	University di Modena e Reggio Emilia	Fabrizio LUPPI	India	无	Jaipur
101	Università di Modena e Reggio Emilia	Fabrizio LUPPI	Italy	IT	MODENA
102	Università degli Studi di Padova	Carlo AGOSTINI	Italy	无	Padova
103	P.O. Clinicizzato	Fernando De Benedetto	Italy	IT	CHIETI SCALO
104	Ospedale San Giuseppe Fatebenefratelli	Sergio HARARI	Italy	无	MILANO
105	Azienda Ospedaliera Universitaria Pisana	Pier Luigi Paggiaro	Italy	无	PISA
106	Azienda Ospedaliera Universitaria Pisana	Laura Maria TAVANTI	Italy	无	PISA
107	Nuovo Ospedale	Alberto PESCI	Italy	IT	MONZA
108	UO Pneumologia interventistica	Venerino POLETTI	Italy	I	Forli'
109	Azienda Ospedaliera Universitaria Senese Le Scotte	Paola ROTTOLI	Italy	无	SIENA
110	Policlinico Universitario Tor Vergata	Cesare SALTINI	Italy	无	ROMA
111	Università Federico II	Alessandro Sanduzzi Zamparelli	Italy	无	NAPOLI
112	National University Corporation Tohoku University Tohoku Uni	Shinya Ohkouchi	Japan	无	Sendai, Miyagi
113	Jichi Medical University Hospital,	Masashi Bando	Japan	无	Shimotsuke,Tochigi
114	National Hospital Organization Ibarakihigashi National Hospi	Takefumi Saito	Japan	无	Naka-gun, Ibaraki
115	Saitama Cardiovascular and Respiratory Center,	Yutaka Sugita	Japan	无	Kumagaya, Saitama
116	Tokyo Medical and Dental University,	Naohiko Inase	Japan	无	Bunkyo-ku,Tokyo
117	Nippon Medical School Hospital,	Yukiko Miura	Japan	无	Bunkyo-ku,Tokyo
118	Fukujuji Hospital,	Kozo Yoshimori	Japan	无	Kiyose, Tokyo
119	National Center for Global Health and Medicine,	Shinyu Izumi	Japan	无	Shinjuku-ku, Tokyo
120	The Jikei University Hospital,	Kazuyoshi Kuwano	Japan	无	Minato-ku, Tokyo
121	JR Tokyo General Hospital,	Tetsuo Yamaguchi	Japan	无	Shibuya-ku, Tokyo
122	Toho University Omori Medical Center,	Sakae Homma	Japan	无	Ota-ku, Tokyo
123	Kanagawa Cardiovascular and Respiratory Center,	Takashi Ogura	Japan	无	Yokohama, Kanagawa
124	Toranomon Hospital,	Kazuma Kishi	Japan	无	Minato-ku, Tokyo
125	Tokyo Medical University Hospital,	Yasuhiro Setoguchi	Japan	无	Shinjuku-ku, Tokyo
126	Tosei General Hospital,	Yasuhiro Kondo	Japan	无	Seto, Aichi
127	Nagoya University Hospital,	Yoshinori Hasegawa	Japan	无	Nagoya, Aichi
128	Ogaki Municipal Hospital,	Joe Shindoh	Japan	无	Ogaki, Gifu
129	Tenri Hospital,	Yoshio Taguchi	Japan	无	Tenri, Nara
130	National Hospital Organization Kinki-Chuo Chest Medical Cent	Yoshikazu Inoue	Japan	无	Sakai, Osaka
131	Kinki University Hospital,	Osamu Nishiyama	Japan	无	Osaka-sayama, Osaka
132	National Hospital Organization Himeji Medical Center,	Tetsuji Kawamura	Japan	无	Himeji, Hyogo
133	Kobe City Hospital Organization Kobe City Medical Center Gen	Keisuke Tomii	Japan	无	Kobe, Hyogo
134	Tottori University Hospital,	Kiyoshi Hashimoto	Japan	无	Yonago, Tottori
135	Tokushima University Hospital,	Yasuhiko Nishioka	Japan	无	Tokushima, Tokushima
136	Toranomon Hospital Kajigaya,	Motochika Tanakadate	Japan	无	Kawasaki, Kanagawa
137	St. Antonius Ziekenhuis	J.C. Grutters	Netherlands	无	NIEUWEGEIN
138	Onze Lieve Vrouwe Gasthuis	P. Bresser	Netherlands	无	AMSTERDAM
139	Erasmus Medisch Centrum	M.S. Wijsenbeek	Netherlands	无	ROTTERDAM
140	Centro Hospitalar So Joo	Antonio Morais	Portugal	无	Porto
141	Centro Hospitalar Lisboa Central	Joao Cardoso	Portugal	无	Lisboa
142	Cento Hospitalar Lisboa Norte	Margarida Serrado	Portugal	无	Lisboa
143	Centro Hospitalar e Universitário de Coimbra, EPE	Ana Arrobas	Portugal	无	Coimbra
144	Centro Hospitalar de Vila Nova de Gaia/Espinho	Sofia Neves	Portugal	无	Vila Nova de Gaia
145	Instituto Nacional de Enfermedades Respiratorias	Moises Eduardo Selman Lama	Mexico	无	Mexico DF
146	Instituto Nacional del Torax	Alvaro Undurraga	Chile	无	Santiago de Chile
147	Asan Medical Center	Dong Soon Kim	Korea, Republic of	无	Seoul
148	Soon Chun Hyang University Hospital Bucheon	Choon Sik Park	Korea, Republic of	无	Bucheon
149	Seoul National University Hospital	Young Whan Kim	Korea, Republic of	无	Seoul
150	Gachon University Gil Medical Center	Sung Hwan Jeong	Korea, Republic of	无	Incheon
151	Soon Chun Hyang University Hospital Seoul	Soo-Taek Uh	Korea, Republic of	无	Seoul
152	The Catholic University of Korea, Yeouido ST.Mary's Hospital	Jeong Sup Song	Korea, Republic of	无	Seoul
153	Masaryk Hospital	Pavel Reiterer	Czech Republic	无	Usti nad Labem
154	University Hospital Na Bulovce	Norbert Pauk	Czech Republic	无	Prague 8
155	Thomayer's Hospital	Martina Vasakova	Czech Republic	无	Prague 4
156	Rabin Medical Center	Mordechai Reuben Kramer	Israel	无	Petah Tiqwa
157	Kaplan Medical Center	Gershon Fink	Israel	无	Rehovot
158	Scientific Research Institute of Pulmonology	Mikhail Ilkovich	Russia	无	St. Petersburg
159	Mehilainen Kielotie, Vantaa	Timo Helin	Finland	无	Vantaa
160	HYKS Keuhkosairauksien tutkimusyksikk	Marjukka Myllarniemi	Finland	无	Helsinki
161	Istanbul Universitesi Cerrahpasa Tip Fakultesi	Gul Ongen	Turkey	无	Istanbul
162	Nesrin Mogulkoc	Ege Universitesi Tip Fakultesi Gogus Hastaliklari A.B.D.	Turkey	无	Izmir
163	Ankara universitesi G gus Hastaliklari Anabilimdali	Oya Kayacan	Turkey	无	Ankara
164	Dr. Suat Seren Gogus Hastaliklari ve Gogus Cerrahisi Hast.	Serir Aktogu	Turkey	无	Izmir
165	Yedikule Gogus Hastaliklari ve Gogus Cer Egitim ve Aras Has	Esin Tuncay	Turkey	无	Istanbul
166	North Bristol NHS Trust	Huzaifa Adamali	Great Britain	AVON	Westbury on Trym
167	Royal Brompton & Harefield NHS Foundation Trust	Toby Maher	Great Britain	无	London
168	Lung Investigation Unit	Dr David Thickett	Great Britain	无	Birmingham
169	Aintree University Hospitals NHS Foundation Trust	Lisa Spencer	Great Britain	无	Liverpool
170	Heart of England NHS Foundation Trust	Peter Burge	Great Britain	无	Birmingham
171	NHS Grampian	Dr Owen Dempsey	Great Britain	SCOT	Aberdeen
172	Oxford Radcliffe Hospitals NHS Trust	Rachel Hoyles	Great Britain	OXON	Oxford
173	Leeds Teaching Hospitals NHS Trust	Paul Beirne	Great Britain	无	Leeds
174	Mater Misericordiae University Hospital Ltd	Katherine O'Reilly	Ireland	无	Dublin
175	HYKS Keuhkosairauksien	UllaHodgson	Finland	Helsinki	Helsinki
176	Cukurova Tip Fakultesi Balcali Hastanesi	Ismail Hanta	Turkey	无	Adana
177	North Bristol NHS Trust Southmead Hospital	AnnMillar	United Kingdom	Westbury	Westbury on Trym
178	Royal Brompton Hospital	Toby Maher	United Kingdom	London	London
179	University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital	Dr DavidThickett	United Kingdom	Alabama	Birmingham
180	Aintree University Hospitals NHS Foundation Trust Aintree University Hospital	LisaSpencer	United Kingdom	Liverpool	Liverpool
181	Birmingham Heartlands Hospital	EmmetMcGrath	United Kingdom	Alabama	Birmingham
182	NHS Grampian Aberdeen Royal Infirmary	Owen Dempsey	United Kingdom	Mississippi	Aberdeen
183	Leeds Teaching Hospitals NHS Trust St James's University Hospital	PaulBeirne	United Kingdom	North Dakota	Leeds
184	Oxford University Hospitals NHS Foundation Trust Churchill Hospital, Oxford Respiratory Trials Unit	RachelHoyles	United Kingdom	Ohio	Oxford

1	AST，ALT > 1.5 倍ULN完成母试验时转氨酶数值> 1.5 倍ULN 但< 3 倍ULN 的患者视为具有资格。
2	胆红素 > 1.5 倍ULN
3	出血风险
4	计划在接下来的3 个月内进行大手术，包括肺移植，腹部大手术或肠道大手术
5	完成母试验后出现新的主要血栓栓子事件
6	母试验访视9 和本研究访视2 之间的时间间隔> 12 周。
7	母试验完成后使用任何试验用药品或在本试验期间计划使用特定的试验用药品。
8	研究者认为患者所患疾病或状况可能使其因参加该试验而导致风险或限制患者参加本试验的能力。
9	研究者认为可能干扰参加试验的酗酒或吸毒。
10	妊娠期妇女、哺乳期妇女或至少在访视2 前1 个月，未采用两种有效节育方法（一种屏障法以及一种高效非屏障法）和/或不愿承诺一直避孕到治疗结束后3 个月的育龄妇女。育龄妇女为除通过子宫切除或双侧输卵管结扎手术绝育或者绝经至少两年以外的所有妇女。
11	不愿承诺在研究期间以及最后一次服用BIBF 1120 后3 个月内使用避孕套的性活跃期男性（其伴侣无生育能力者除外）

相关临床试验招募信息

常见问题

1	在参加试验前签署符合ICH-GCP 和当地法律规定的知情同意书。
2	来自试验1199.32 或1199.34 的已完成52 周治疗期并进行了随访的患者。