Efficacy Study of Granulocytapheresis Plus Steroids vs Steroids Alone in Active Steroid Dependant Ulcerative Colitis
NCT ID: NCT00702611
Last Updated: 2015-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE4
133 participants
INTERVENTIONAL
2008-06-30
2013-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Adacolumn in Refractory UC Patients Trial
NCT01481142
Granulocyte-monocyte Apheresis in Ulcerative Colitis
NCT03189888
National GMA Post-market Clinical Follow-up Study (GRACE)
NCT05636709
Endovenous Corticosteroid Pulses in Moderate Ulcerative Colitis
NCT02921555
Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics
NCT06109441
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Seven apheresis treatments over seven consecutive weeks (1/week) in conjunction with a starting dose of 40mg of oral prednisone per day at Week 00 for two weeks which will be tapered down to zero 5 mg/week within nine weeks
Granulocyte Monocyte Apheresis (GMA-Apheresis)
GMA Apheresis will be performed in a once per week during seven weeks only in experimental arm. Each apheresis will last 60 minutes at a blood flow rate of 30 ml/min.
2
Treatment with starting dose of 40mg of oral prednisone per day at Week 00 for two weeks and tapered down to zero 5 mg/week within nine weeks
Granulocyte Monocyte Apheresis (GMA-Apheresis)
GMA Apheresis will be performed in a once per week during seven weeks only in experimental arm. Each apheresis will last 60 minutes at a blood flow rate of 30 ml/min.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Granulocyte Monocyte Apheresis (GMA-Apheresis)
GMA Apheresis will be performed in a once per week during seven weeks only in experimental arm. Each apheresis will last 60 minutes at a blood flow rate of 30 ml/min.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Active ulcerative colitis with documented clinical symptoms and endoscopic findings
* Active disease defined as DAI (Mayo score) ≥ 4 and ≤10 with at least 1 point in flexible sigmoidoscopy
* Steroid dependency as defined by:
A. Inability to withdraw corticosteroids within three months of starting treatment, without recurrent active disease
B. appearance of relapse within 3 months after withdrawal of corticosteroids
* Colonic involvement with ulcerative colitis beyond 15cm of the anal verge
* Stable doses:A. Aminosalicylates for the last 4 weeks B. Prednisolone or equivalent dose ≤ 20 mg/day for the last 2 weeks C. Azathioprine or 6-mercaptopurine at stable dose for the last 12 weeks
* Signed informed consent form
* Agree to participate in the required follow-up visits
* Able to complete the diary
Exclusion Criteria
* Evidence of toxic megacolon
* Anticipated need for surgery within 24 weeks
* Known obstructive diseases of the gastrointestinal system
* Proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis
* A history of allergic reaction to heparin or heparin-induced thrombocytopenia
* A history of hypersensitivity reaction associated with an apheresis procedure or intolerance of apheresis procedures
* Requires a central venous access catheter for the apheresis treatments
* Known infection with enteric pathogens, pathogenic ova or parasites, C. difficile toxin or CMV
* Hypotension (systolic blood pressure \<80 mmHg and/or diastolic blood pressure \<50 mmHg) at screening visit only
* Uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>120 mmHg) despite medical therapy
* A history of myocardial infarction or unstable angina within the past 6 months
* A history of coronary artery bypass grafting surgery or angioplasty within the past 6 months
* Prosthetic heart valve, pacemaker or other permanent implant
* Severe cardiovascular or peripheral vascular disease, severe renal disease
* Liver disease defined as levels of SGOT \[AST\], SGPT \[ALT\] or alkaline phosphatase \>2.5x the upper limit of the normal range for the laboratory performing test
* History of cirrhosis
* Known bleeding disorder (PT or PTT\>1.5x the upper limit of the normal range for the laboratory performing the test), or concomitant anticoagulant therapy for purposes other than apheresis treatment
* Prior history suggestive of a hypercoagulable disorder, including 1 or more episodes of pulmonary embolism or deep vein thrombosis
* Known infection with Hepatitis B or C, or HIV
* Abnormal hematology parameters defined as severe anemia with hemoglobin \<8.5g/dL, white blood cell count of \<3,500/μl and a granulocyte count \< 2,000/μl
* Fibrinogen level \>700mg/dL
* Major surgery within the past 6 months
* Infection:Active infections less than 4 weeks from successful completion of antibiotic treatment for routine bacterial infectionFebrile viral infection within 4 weeks of entry into the clinical investigationLess than 12 weeks from conclusion of therapy for systemic fungal infections
* Malignancy within the past 2 years other than surgically cured skin carcinoma or cervical dysplasia (CIN I-II)
* History of dysplasia or carcinoma of the colon or lack of a complete colonoscopy in the last 12 months in patients with longstanding UC (\> 10 años)
* Current drug or alcohol abuse
* Pregnant, lactating or planning to become pregnant during the course of the clinical investigation
* Used within the last 30 days an investigational drug, biologic or device or 5 half-lifes, if known, for any investigational drug or biologic
* Received cyclosporine or tacrolimus within the last 8 weeks
* Received infliximab within the last 8 weeks
* Fulminant ulcerative colitis
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Julian Panes, Ph D
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic i Provincial Barcelona
Joaquín Hinojosa, Ph D
Role: STUDY_CHAIR
Geteccu President
Daniel Ginard, MD
Role: STUDY_DIRECTOR
Hospital Son Dureta Palma de Mallorca
Eugeni Domenech, Ph D
Role: PRINCIPAL_INVESTIGATOR
Germans Trias i Pujol Hospital
Raul Lafuente, MD
Role: PRINCIPAL_INVESTIGATOR
Otsuka Pharmaceutical S.A.
Fernando Magro, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital San Joao, Oporto
Vito Annesse, Ph D
Role: PRINCIPAL_INVESTIGATOR
Casa Sollievo de la Sofferenza, Italy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical University of Vienna
Vienna, , Austria
Katolische Kliniken Ruhrhalbinsel
Essen, , Germany
Markus-Krankenhaus
Frankfurt, , Germany
Policlinico di Bari
Bari, , Italy
Ospedale di Belluno
Belluno, , Italy
Azienda Ospedaliero-Universitaria di Careggi
Florence, , Italy
L'Azienda Unità Sanitaria Locale di Forlì
Forlì, , Italy
Istituto Policlinico S. Donato
Milan, , Italy
Policlinico di Padova
Padua, , Italy
Policlinico Universitario Tor Vergata
Roma, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
Casa Sollievo della Sofferenza, Istituto di Ricovero e Cura a Carattere Scientifico, Opera di San Pio da Pietrelcina
San Giovanni Rotondo, , Italy
Hospital da Universidade de Coimbra
Coimbra, , Portugal
Hospital Santa Maria
Lisbon, , Portugal
Instituto Portuges Oncologia Lisboa Francisco Gentil
Lisbon, , Portugal
Hospital Geral Santo Antonio
Porto, , Portugal
Hospital de Sao Joao
Porto, , Portugal
Hospital de Sao Bernardo
Setúbal, , Portugal
Hospital Sao Teotonio
Viseu, , Portugal
Complejo Hspitalario Universitario Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
Complejo Universitario de Albacete
Albacete, Albacete, Spain
Hospital General Universitario de Alicante
Alicante, Alicante, Spain
Hospital General de Elche
Elche, Alicante, Spain
Complejo Hospitalario Reina Sofía
Córdoba, Andalusia, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Clinic i Provincial
Barcelona, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Mutua de Terrassa
Terrassa, Barcelona, Spain
Hospital de Galdakano
Galdakao, Bilbao, Spain
Hospital Son Dureta
Palma de Mallorca, Comunidad Balear, Spain
Complejo Hospitalario Universitario Juan Canalejo
A Coruña, Galicia, Spain
Hospital Josep Trueta
Girona, Girona, Spain
Hospital de Donostia
Donostia / San Sebastian, Guipuzcoa, Spain
Hospital de Leon
León, Leon, Spain
Clínica Puerta de Hierro
Madrid, Madrid, Spain
Hospital Fundación de Alcorcón
Madrid, Madrid, Spain
Hospital Universitario Clínico de San Carlos
Madrid, Madrid, Spain
Hospital de Navarra
Pamplona, Navarre, Spain
Hospital Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Puerto de Sagunto
Sagunto, Valencia, Spain
Hospital de Manises
Valencia, Valencia, Spain
Hospital Insular de Las Palmas
Las Palmas de Gran Canaria, , Spain
Hospital Costa del Sol
Málaga, , Spain
Hospital Virgen de la Arrixaca
Murcia, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital do Meixoeiro
Vigo, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Official web page of the GETECCU group
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Ada-UC-07-102
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.