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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TERMINATED
PHASE2
88 participants
INTERVENTIONAL
2007-07-31
2008-12-31
Brief Summary
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Secondary Objectives: evaluate the efficacy and assess the immunogenicity of this multiple-dose maintenance regimen in this population
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Basiliximab
Study Drug: basiliximab 40 mg, given as a short intravenous infusion Dosing Schedule: once every 4 weeks Concomitant Therapy: Oral corticosteroids (prednisone or equivalent) will be tapered during the first few months of the study participation Duration of Study Participation: The duration of individual study participation will vary.
Interventions
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Basiliximab
Study Drug: basiliximab 40 mg, given as a short intravenous infusion Dosing Schedule: once every 4 weeks Concomitant Therapy: Oral corticosteroids (prednisone or equivalent) will be tapered during the first few months of the study participation Duration of Study Participation: The duration of individual study participation will vary.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Must have a total Mayo score at entry consistent with clinical response or clinical remission.
3. Signed a current IRB/IEC-approved informed consent form
4. Females of childbearing potential must use an effective birth control method, and be willing to continue birth control during the study, and for 4 months after the last dose of study drug.
5. Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months before study entry, hysterectomy, or bilateral oophorectomy at least 2 months before study entry) or post-menopausal for at least 2 years.
Exclusion Criteria
* Heart rate \> 90 beats/min at rest
* Temperature \> 37.8 degrees C
* Hemoglobin \< 10.5 g/dL
2. Subject is currently receiving a restricted/prohibited concomitant medication
3. Subject has undergone colectomy (total, or subtotal)
4. Subject is pregnant or breast-feeding
5. Prior noncompliance with previous study visit schedule and requirements
18 Years
75 Years
ALL
No
Sponsors
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Cerimon Pharmaceuticals
INDUSTRY
Responsible Party
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Cerimon Pharmaceuticals, Inc.
Principal Investigators
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Shaily J. Reichert
Role: STUDY_DIRECTOR
Cerimon Pharmaceuticals
Locations
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Bristol, , United Kingdom
Countries
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Other Identifiers
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BSX-002
Identifier Type: -
Identifier Source: org_study_id
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