A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of rhuMAb Beta7 in Patients With Ulcerative Colitis
NCT ID: NCT00694980
Last Updated: 2016-11-02
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
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2008-09-30
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
placebo
Intravenous and subcutaneous escalating doses
rhuMAb Beta7
Intravenous and subcutaneous escalating doses
Interventions
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placebo
Intravenous and subcutaneous escalating doses
rhuMAb Beta7
Intravenous and subcutaneous escalating doses
Eligibility Criteria
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Inclusion Criteria
* 18-70 years of age
* Males and females with reproductive potential: Willing to use a reliable method of contraception
* Diagnosis of ulcerative colitis
* Eligible to receive biologic therapy
* Disease duration of \>=12 weeks
Exclusion Criteria
* Moderate to severe anemia
* Any manifestation of ulcerative colitis or other conditions likely to require, in the investigator's judgment, treatment with \>20 mg/day of prednisone, or prednisone equivalent, during the course of the study
* Pregnant or lactating
* Lack of peripheral venous access
* Inability to comply with study protocol
* History or presence of contraindicated diseases
* Congenital immune deficiency
* Active or prior infection with HIV or hepatitis B or C
* History of severe systemic bacterial, fungal, viral, or parasitic infections
* History of any other opportunistic infections within 12 weeks prior to initiation of study treatment
* Received a live attenuated vaccine within 4 weeks prior to screening
* Hospitalized within 4 weeks prior to screening
* Received any contraindicated therapy within 12 weeks prior to screening
18 Years
70 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Anniston, Alabama, United States
San Francisco, California, United States
Gainesville, Florida, United States
Atlanta, Georgia, United States
Lexington, Kentucky, United States
Rochester, Minnesota, United States
Great Neck, New York, United States
Chapel Hill, North Carolina, United States
Leuven, , Belgium
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
London, Ontario, Canada
Montreal, Quebec, Canada
Berlin, , Germany
Frankfurt, , Germany
Kiel, , Germany
Regensburg, , Germany
Ulm, , Germany
Leiden, , Netherlands
Maastricht, , Netherlands
Nijmegen, , Netherlands
Utrecht, , Netherlands
Bristol, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Nottingham, , United Kingdom
Countries
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Other Identifiers
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GA00930
Identifier Type: OTHER
Identifier Source: secondary_id
ABS4262g
Identifier Type: -
Identifier Source: org_study_id