View Clinical Trial (Medical Research Study)
Phase II Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis
| City: |
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Rochester |
| State: |
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Minnesota |
| Zip Code: |
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55905 |
| Conditions: |
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Ulcerative Colitis |
| Purpose: |
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This Phase II study is a randomized, double-blind, placebo-controlled multicenter study to
evaluate the efficacy and safety of rhuMAb Beta7 in patients with moderate to severe
ulcerative colitis.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Diagnosis of moderate to severe ulcerative colitis outpatient
- Disease duration at time of screening of >/= 12 weeks
Exclusion Criteria:
- Extensive colonic resection or subtotal or total colectomy
- Presence of an ileostomy or colostomy
- Moderate to severe anemia
- A history or evidence of colonic mucosal dysplasia
- Pregnant or lactating
- Significant uncontrolled co-morbidity, such as neurological, cardiac, pulmonary,
renal, hepatic, endocrine, or gastrointestinal (GI) disorders
- Significant screening ECG abnormalities, including evidence of acute myocardial
infarction, complete left bundle branch block, second-degree heart block, or complete
heart block
- Poorly controlled diabetes
- Impaired renal function
- Impaired hepatic function in the absence of a diagnosis of primary sclerosing
cholangitis
- Positive tests for antibodies indicating active or prior infection with HIV or
hepatitis B (HBV) or C (HCV)
- Positive screening test for latent mycobacterium tuberculosis (TB) infection
- Demyelinating disease
- Received any investigational treatment within 12 weeks prior to initiation of study
treatment
- Previous exposure to rhuMAb Beta7
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| NCT ID: |
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NCT01336465 |
| Primary Contact: |
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Study Director
Sharon O'Byrne, M.D.
Genentech
Genentech Trial Information Support Line
Phone: 888-662-6728 (U.S. Only)
Email: global.rochegenentechtrials@roche.com
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| Backup Contact: |
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N/A |
| Location Contact: |
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Rochester, Minnesota 55905
United States
There is no listed contact information for this specific location.
Site Status: Not yet recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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