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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00306215
Other study ID # CL004_282
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 2006
Est. completion date June 2009

Study information

Verified date August 2023
Source ChemoCentryx
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether CCX282-B is effective in treating patients with moderate to severe Crohn's Disease.


Recruitment information / eligibility

Status Completed
Enrollment 436
Est. completion date June 2009
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria: - moderate to severe Crohn's Disease - CDAI 250-450 - CRP >7.5 - signed written informed consent Key Exclusion Criteria: - > 100 cm of small bowel resected - ileostomy, colostomy or rectal pouch - diagnosis of ulcerative colitis or indeterminate colitis - evidence of short bowel syndrome requiring enteral or parenteral supplementation or total parenteral nutrition - hepatitis B, C or HIV infection - history of infection requiring IV antibiotics - serious or GI infection in the previous 12 weeks

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CCX282-B
CCX282-B or placebo capsules

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Bankstown - Lidcombe Hospital Bankstown New South Wales
Australia Flinders Medical Centre Bedford Park South Australia
Australia Box Hill Hospital Box Hill Victoria
Australia St Vincents Hospital Fitzroy Victoria
Australia Bayside Gastroenterology Frankston Victoria
Australia Fremantle Hospital Fremantle Western Australia
Australia Royal Brisbane and Womens Hospital Herston Queensland
Australia Launceston General Hospital Launceston Tasmania
Australia Royal Melbourne Hospital Parkville Victoria
Australia The Alfred Hospital Prahran Victoria
Austria Universitätsklinik für Innere Medizin Innsbruck
Austria A.ö. Krankenhaus der Elisabethinen Linz Linz
Austria Landesklinikum St. Poelten Poelten
Austria Krankenanstalt Rudolfstiftung Wien
Austria Universitätsklinik für Innere Medizin III Wien
Belgium UZ Gent Gent
Belgium UZ Gasthuisberg Leuven
Brazil Unigastro Campinas
Brazil Centro Petropolitano de Reumatologia e Fisioterapia Centro Petrópolis
Brazil Hospital das Clínicas de Curitiba UFPR Curitiba
Brazil Instituto Goiano de Gastro Goiania
Brazil Hospital Geral de Goiânia Goiânia
Brazil Hospital de Clínicas de Porto Alegre Porto Alegre
Brazil Hospital São Lucas PUC-RS Porto Alegre
Brazil Hospital Universitário Clementino Fraga Filho Rio de Janeiro
Brazil Santo André Diagnósticos e tratamentoLtda. Santo André
Brazil Irmandade da Santa Casa de Misericórdia de Santos Santos
Brazil Irmandade da Santa Casa de Misericórdia de São Paulo Sao Paulo
Brazil Hospital das Clínicas de São Paulo São Paulo
Brazil Hospital Israelita Albert Einstein São Paulo
Bulgaria 4 MHAT, 38 "Makedonia" 1000 Sofia
Bulgaria Military Medical Academy Sofia
Bulgaria UMHAT "Alexandrovska" Sofia
Bulgaria UMHAT Queen Joanna Sofia
Bulgaria UMHAT" St. Ivan Rilsky" Sofia
Bulgaria V City Hospital Sofia
Bulgaria UMHAT "St. Marina" Varna
Canada Health Science Centre Calgary Alberta
Canada Centre Hospitalier--Hotel-Dieu de Levis Levis Quebec
Canada Hopital Maisonneuve-Rosemont Montreal Quebec
Canada Jewish General Hospital Montreal Quebec
Canada CHAUQ-Hopital St-Sacrement Quebec
Canada DHC Research Richmond Hill Ontario
Canada Mt. Sinai Hospital Toronto Ontario
Canada Lair Centre Vancouver British Columbia
Czechia Private Gastroenterology Centre Ceské Budejovice
Czechia Hepato-Gastroenterologie, Edvarda Benese 1549 Hradec Kralove
Czechia II.Interni klinika, Endoskopie Olomouc
Czechia General University Hospital Prague Prague
Czechia Medic Kral ltd. Prague
Czechia Fakultni nemocnice Praha
Czechia Klinika hepatogastroenterologieIKEM Praha
Czechia Regional Hospital Pribram Pribram
Czechia Regional Hospital Tabor Tabor
Denmark Medical Department V Århus University Hospital Arhus C
Denmark Herlev Hospital Gastroenterologisk department Herlev
Denmark Hvidovre Hospital Hvidovre
Denmark Medical department S Odense University hospital Odense
France CHU Amiens - Hôpital Nord Amiens
France Service d'Hépato-Gastroentérologie et de Nutrition Clinique Nice
France Hopital du Haut-Lévêque Pessac
France Hôpital Charles Nicolle Rouen
France Service de Gastro-Enterologie et Nutrition Toulouse
Germany Charité Campus Mitte, Universitätsmedizin Berlin Berlin
Germany Medizinische Klinik m.S. Hepatologie, Gastroenterologie, Endokrinologie und Stoffwechsel Berlin
Germany Fachärztin für Innere Medizin Hamburg
Germany Klinikum der Christian-Albrechts-Universität zu Kiel Kiel
Germany Universitätsklinikum Magdeburg A.ö.R Magdeburg
Germany Gastroenterologische Praxis am Germania-Campus Münster
Germany Klinikum der Universität Regensburg Regensburg
Hungary Réthy Pál Kórház Bekescsaba
Hungary Fovárosi Önkormányzat Bajcsy-Zsilinszky Kórház Budapest
Hungary Debreceni Egyetem OEC Debrecen
Hungary Vaszary Kolos Kórház Esztergom
Hungary Petz Aladár Megyei Oktató Kórház Gyor
Hungary BAZ Megyei Kórház Miskolc
Israel Soroka Medical Center Beer-Sheva
Israel Bnai Zion MC Haifa
Israel Rambam Medical Center, Haifa
Israel Hadassah Ein-Karem Medical Center Jerusalem
Israel Meir Hospital Kfar-Saba
Israel Rabin Medical Center Petach Tikva
Israel Kaplan Medical Center Rechovot
Israel The Tel-Aviv Sourasky Medical Center Tel Aviv
Israel Assaf Harofeh Medical Center Trzifin
Netherlands Ringweg Randenbroek 110 Amersfoort
Netherlands Ikazia Ziekenhuis Rotterdam
Netherlands Isala Klinieken Locatie Sophia Afd. Interne Geneeskunde Zwolle
Poland ZOZ MSWiA Oddzial Chorób Wewnetrznych Bialystok
Poland 10 Wojskowy Szpital Klinicznym, Oddzial Kliniczny Gasteroenterologii Bydgoszcz
Poland SPZOZ Wojewodzki Szpital Bydgoszcz
Poland Klinika Chorob Wewnetrznych I Gastroenterologii Krakow
Poland Samodzielny Publiczny Szpital Kliniczny Nr 4 Lublin
Poland SPZOZ Szpital Wojewódzki w Opolu Opole
Poland SOPMED Niepubliczny Zaklad Opieki Zdrowotnej Sopot
Poland Klinika Gastroenterologii i Chorób Wewnetrznych Samodzielny Publiczny Szpital Kliniczny nr 1 im. T. Sokolowskiego Pomorskiej Akademii Medycznej ul.Unii Lubelskiej 1 Szczecin
Poland Wojskowy Insytutu Medyczny Warsaw
Poland CSK MSWiA, Klinika Gastroenterologii Warszawa
Poland NZOZ Vivamed Zespól Lekarzy Specjalistów ul. Trocka 10A Warszawa
Poland Klinika Gastroenterologii i Hepatologii, Akademii Medycznej Wroclaw
South Africa GastroEnterology Unit, Groote Schuur Hospital Cape Town
South Africa Louis Leipoldt Gastroenterology Centre, Louis Leipoldt Medical Centre Cape Town
South Africa Panorama Medi Clinic Cape Town
South Africa Quatro Clinical Trial Institute Cape Town
South Africa 427 Ontdekkers Road, Florida Park Johannesburg
Sweden Medicinkliniken, SU/Östra sjukhuset Göteborg
Sweden Universitetssjukhuset Lund
Sweden Medicinmottagningen, Södersjukhuset Stockholm
Sweden Sophiahemmet Stockholm
United Kingdom Centre for Gastroenterology Royal Free Hospital London
United Kingdom Dept of Gastroenterology, John Radcliffe Hospital Oxford

Sponsors (1)

Lead Sponsor Collaborator
ChemoCentryx

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Czechia,  Denmark,  France,  Germany,  Hungary,  Israel,  Netherlands,  Poland,  South Africa,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of subjects achieving a clinical response (defined as a decrease from baseline in Crohn's Disease Activity Index [CDAI] score of at least 70) on Day 57 Day 57
Secondary Percentage of subjects achieving clinical remission (defined as a Crohn's Disease Activity Index [CDAI] score less than or equal to 150) on Day 57 Day 57
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