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Efficacy Study of Granulocytapheresis Plus Steroids vs Steroids Alone in Active Steroid Dependant Ulcerative Colitis

NCT00702611 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2015-09-07

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy of the addition of GMA apheresis to steroid conventional treatment for achieving and maintaining remission in Active steroid dependant Ulcerative Colitis patients

Conditions

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

    lead OTHER

Principal Investigators

  • Julian Panes, Ph D · Hospital Clinic i Provincial Barcelona

  • Joaquín Hinojosa, Ph D · Geteccu President

  • Daniel Ginard, MD · Hospital Son Dureta Palma de Mallorca

  • Eugeni Domenech, Ph D · Germans Trias i Pujol Hospital

  • Raul Lafuente, MD · Otsuka Pharmaceutical S.A.

  • Fernando Magro, PhD · Hospital San Joao, Oporto

  • Vito Annesse, Ph D · Casa Sollievo de la Sofferenza, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Austria
  • Germany
  • Italy
  • Portugal
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00702611 on ClinicalTrials.gov