1079 popescu/mihaela radulescu/oana comisia nationala de bioetica a medicamentului si a...

Primary Investigator/Address* Country Protocol # - Site #

Sub-Investigators IEC Name and Address Committee Chair/Alternate** # of Subjects Randomized/Treated

Jan Sperl,M.D. Institut klinicke a experimentalni mediciny (IKEM)

Vladimir Stanek

Videnska 1958/9 Videnska 800Klinika hepatogastroenterologie Eticka komise IKEM a TNPraha 4, 140 21 Praha 4 140 59Czech Republic Czech Republic

Fakultni nemocnice Brno Sarka KozakovaJihlavska 20Eticka komise FN BrnoBrno 625 00Czech Republic

Petr Urbanek,M.D., Ph.D. University Hospital Brno Kozakova SarkaJugoslavska 16/567 Jihlavska 20Praha 2, 120 00 Lokalni Eticka komise FN BrnoCzech Republic Brno 625 00

Czech RepublicFakultni nemocnice Brno Sarka KozakovaJihlavska 20Eticka komise FN BrnoBrno 625 00Czech Republic

Petr Husa,M.D., Ph.D. Ethics Committee FN Brno Sarka KozakovaJihlavska 20 Jihlavska 20Klinika infekcnich chorob Brno 62500Brno, 625 00 Czech RepublicCzech Republic Fakultni nemocnice Brno Sarka Kozakova

Jihlavska 20Eticka komise FN BrnoBrno 625 00Czech Republic

Petr Kumpel,M.D. Slezska nemocnice v Opave Marie ZajicovaOlomoucka 86 Olomoucka 86Infekcni oddeleni Eticka komiseOpava, 746 01 Opava 746 01Czech Republic Czech Republic

Fakultni nemocnice Brno Sarka KozakovaJihlavska 20Eticka komise FN BrnoBrno 625 00Czech Republic

Jan Gerstoft,M.D. De Videnskabsetiske Komiteer For Region Hovedstaden

Simon FrancisThomsen

Blegdamsvej, 9. Kongens vaenge 2Afsnit 8622. Opgang 86 - 2. sal RegionsgaardenCopenhagen, 2100 Hilleroed 3400Denmark DenmarkNina Weis,M.D. De Videnskabsetiske Komiteer For Region

HovedstadenKettegaard Alle 30 Kongens Vaenge 2Department of Infectious Diseases. Section 144 RegionsgaardenHvidovre, 2650 Hilleroed, Denmark 3400Denmark DenmarkAndrzej Horban,M.D., Ph.D.ul. Wolska 37Dzial Badan KlinicznychWarszawa, 01-201PolandWaldemar Halota,Prof. Poland 5172-077-0064 Dorota

Dybowska/Kornelia Karwowska/Dorota Kozielewicz

Komisja Bioetyczna przy Centrum Medycznym Kształcenia Podyplomowego, Marymoncka 99/103 Street, Warsaw 01-813, Poland

Ewa Marcinkowska-Suchowierska

11

ul. sw. Floriana 12Bydgoszcz, 85-030PolandEwa Janczewskaul. Janowska 19Myslowice, 41-400PolandRobert Flisiak,Prof.Zurawia 14Klinika Chorob Zakaznych. Hepatologii UMBBialystok, Podlaskie, 15-540PolandLiliana GheorgheSos. Fundeni nr. 252Etaj 4Bucuresti, 022328RomaniaAdrian Streinu-CercelStr. Calistrat Grozovici 1Sectia 2, Pavilion 5 (Sector 2)Bucuresti, 021105RomaniaAdrian GoldisStr. Lucian Blaga nr. 4Timisoara, 300002RomaniaIoan Sporea,Prof., DR.Str. Iosif Bulbuca nr. 10Clinica de Gatroenterologie, Etaj 7Timisoara, 300726RomaniaGabriel Moraru

List of Investigators and Independent Ethics Committees

Czech Republic 5172-077-0001 Sona Frankova 21

Czech Republic 5172-077-0004 Ivo Hiemer 0

Denmark 5172-077-0021 Susanne Dam/Marie Helleberg/Jannik Helweg-Larsen/Ole Kirk/Birgitte Madsen/Frederikke

3

Czech Republic 5172-077-0002 Zdenek Marecek 11

Czech Republic 5172-077-0003 Pavel Slesinger 8

Denmark 5172-077-0022 Thomas Lars Benfield/Ann-Britt Eg Hansen/Morten Helms/Gitte Kronborg/Anne-Mette Lebech/Lars

Simon FrancisThomsen 3

Poland 5172-077-0063 Hanna Berak/Anna Kolakowska-Rzadzka/Aleksandra Korczynska/Antoni Platowski



Poland 5172-077-0065 Damian Piotrowski/Arkadiusz Pisula/Wioleta Warunek



12

11

Romania 5172-077-0105 Speranta Iacob/Roxana Vadan

Comisia Nationala de Bioetica a Medicamentului si a Dispozitivelor Medicale, Sos. Stefan cel Mare nr. 19-21, Bucuresti, 020125, Romania

Dinu Antonescu 7

Poland 5172-077-0067 Tadeusz Lapinski/Tomasz Szulzyk



11

Romania 5172-077-0107 Razvan Diaconescu/Ramona Amalia Goldis/Mariana M l k/P t k


Dinu Antonescu 8

Romania 5172-077-0106 Victoria NA Arama/Gabriela Ceapraga/Daniela Manolache/Cristina Popescu/Mihaela Radulescu/Oana


Dinu Antonescu 12

Romania 5172-077-0109 Mihaela

Comisia Nationala de Bioetica a Medicamentului

Dinu Antonescu 7

Romania 5172-077-0108 Ana Palicsak/Roxana Sirli


Dinu Antonescu 5

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Str. Crisului nr. 2Brasov, 500283RomaniaGabor Horvath,M.D. Egeszsegugyi Tudomanyos TanacsEgry Jozsef u. 3. Arany Janos u. 6-8.T epulet. Foldszint Klinikai Farmakologiai Etikai Bizottsaga (ETT

KFEB)Budapest, 1111 Budapest 1051Hungary HungaryBela Hunyady,Prof. Egeszsegugyi Tudomanyos TanacsTallian Gy. u. 20-32 Arany Janos u. 6-8.BelgyogyaszatKaposvar, 7400 Budapest 1051Hungary HungaryKlara Werling Egeszsegugyi Tudomanyos TanacsSzentkiralyi u. 46. Arany Janos u. 6-8.II. Belgyogyaszati KlinikaBudapest, 1088 Budapest 1051Hungary HungaryAnna Tusnadi,M.D. Egeszsegugyi Tudomanyos TanacsToszegi ut 21. Arany Janos u. 6-8.Infektologiai Osztaly. K epulet FszSzolnok, 5004 Budapest 1051Hungary HungaryLigita Jancoriene,Ph.D. Lietuvos Bioetikos KomitetasBirutes g. 1 Didzioji g. 22Konsultaciju ir imunoprofilaktikos skyrius Vilnius LT-01128Vilnius, 08117 LithuaniaLithuaniaJolita Jakutiene,M.D. Lithuania 5172-077-0148 Arida

Buivydiene/Edita Kazenaite

Lietuvos Bioetikos Komitetas Eugenijus Gefenas 11

Santariskiu g. 2 Didzioji g. 22Klinikines farmakologijos skyrius Vilnius LT-01128Vilnius, 08661 LithuaniaLithuaniaLimas Kupcinskas,Prof., DR., Med. Lithuania 5172-077-0149 Jurate Lietuvos Bioetikos Komitetas Eugenijus Gefenas 10Eiveniu g. 2 Didzioji g. 22Gastroenterologijos klinika Vilnius LT-01128Kaunas, 50009 LithuaniaLithuaniaAukse Mickiene,Prof., DR., Med. Lithuania 5172-077-0150 Violeta

Lietuvos Bioetikos Komitetas Eugenijus Gefenas 5

Josvainiu g. 2 Didzioji g. 22Infekciniu ligu klinika Vilnius LT-01128Kaunas, LT - 47144 LithuaniaLithuaniaMaria de los Angeles Castro Iglesias,DR. SERGASAs Xubias de Arriba, 84 C/ San Lazaro, s/nServicio de Medicina Interna B Edificio Administrativo. Servicio Galego de

Saude (SERGAS)A Coruna, 15006 Santiago de Compostela 15703Spain SpainYolanda Real Martinez,DR.C/Diego de Leon, 62Servicio de Aparato Digestivo. Hepatologia. Planta 3Madrid, 28006SpainJuan Ignacio Arenas Ruiz-Tapiador Comite Etico de Investigacion Clinica Regional

Pais VascoPaseo Dr. Beguiristain, s/n Calle Donostia San Sebastian, 1Servicio de Digestivo. Planta 3 Departamento de Sanidad del Gobierno VascoSan Sebastian, 20014 Vitoria, Alava 01010Spain SpainRafael Alexander Modahl LeivaJonas Lies vei 65Infeksjonsmedisinsk avdelingBergen, 5021NorwayHege Kileng/Hege KilengSykehusveien 38Gastromedisinsk avdelingTromsoe, 9038NorwayBilgehan AygenErciyes UTFEnfeksiyon ve Klinik Mikrobiyoloji ABDKayseri, 38039TurkeyOsman Yuksel,Prof., DR./Seyfettin Koklu,DR., Med.

Hacettepe Unv Tip Fak Ic Hast ABDGastroentoroloji Bolumu SihhiyeAnkara, 06100TurkeySila Akhan CetinKocaeli Unv. KampusuUmut Tepe Yerleskesi. Enfeksiyon Hastaliklari BD.

Kocaeli, 41380TurkeyAltay CelebiKocaeli UTF Gastroentoroloji ABDUmuttepe YerleskesiKocaeli, 41380TurkeyMustafa Kemal Celen,Prof., DR., Med.Dicle UTF Infeksiyon Hastaliklari ve klinik Mikrobiyoloji ABDDiyarbakir, 21280

Bancu/Maria Elena Cocuz/Rodica Silaghi/Stefan B at Simbotean

si a Dispozitivelor Medicale, Sos. Stefan cel Mare nr. 19-21, Bucuresti, 020125, Romania

Hungary 5172-077-0126 Mihaly Makara Zsuzsanna Furst 20

Hungary 5172-077-0127 Attila Haragh/Bela Hunyady/Zsolt Szinku

Zsuzsanna Furst 5

Hungary 5172-077-0128 None Zsuzsanna Furst 6

Hungary 5172-077-0129 Timea Ecseki/Anna Tusnadi

Zsuzsanna Furst 6

Lithuania 5172-077-0147 Alina Voinic Eugenijus Gefenas 12

5

Spain 5172-077-0170 Francisco Javier Esandi Gonzalez/Alexandra Gomez Garcia/Leticia Martin

Patricia Torres 9

Spain 5172-077-0168 Alvaro Mena de Cea/Berta Pernas Souto/Iria Rodriguez Osorio

Alvaro Castro 7

Spain 5172-077-0169 Leticia Gonzalez Moreno/Dolores Ochoa Mazarro/Yolanda Real Martinez

CEIC Hospital Universitario La Princesa, C/Diego De Leon, Madrid 28006, Spain

Patricia Torres

Norway 5172-077-0190 Jon Florholmen Postboks 1130, Blindern, Oslo 0318, Norway Grete Dyb 6

Norway 5172-077-0189 None Postboks 1130, Blindern, Oslo 0318, Norway Grete Dyb 5

Turkey 5172-077-0232 Seyfettin Koklu Kocaeli University Faculty of Medicine Ethics Committee, Kocaeli Universitesi Tip Fakultesi KABI, Umuttepe, Kocaeli, 41380, Turkey

Ersoy, Nermin 7

Turkey 5172-077-0231 Orhan Yildiz Kocaeli University Faculty of Medicine Ethics Committee, Kocaeli Universitesi Tip Fakultesi KABI, Umuttepe, Kocaeli, 41380, Turkey

Ersoy, Nermin 4

Turkey 5172-077-0234 Omer Senturk/Hasan Yilmaz

Kocaeli University Faculty of Medicine Ethics Committee, Kocaeli Universitesi Tip Fakultesi KABI, Umuttepe, Kocaeli, 41380, Turkey

Ersoy, Nermin 3

Turkey 5172-077-0233 Salih Cakiroglu Kocaeli University Faculty of Medicine Ethics Committee, Kocaeli Universitesi Tip Fakultesi KABI, Umuttepe, Kocaeli, 41380, Turkey

Ersoy, Nermin 3

Turkey 5172-077-0235 Celal Ayaz Kocaeli University Faculty of Medicine Ethics Committee, Kocaeli Universitesi Tip Fakultesi KABI, Umuttepe, Kocaeli, 41380, Turkey

Ersoy, Nermin 3

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Turkey

* If the original investigator has been replaced, that investigator’s name is followed by a slash (/) and the replacement investigator’s name.** Names of individual IEC members available upon request.

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1079 popescu/mihaela radulescu/oana comisia nationala de bioetica a medicamentului si a...

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