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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01061996 |
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Date of registration:
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02/02/2010 |
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Primary sponsor: |
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Public title:
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Basiliximab Maintenance in Ulcerative Colitis
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Scientific title:
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An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis |
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Date of first enrolment:
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July 2007 |
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Target sample size:
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88 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT01061996 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Shaily J. Reichert |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cerimon Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Previously met eligibility criteria in the previous basiliximab UC study
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:
1. Subject is severely ill, as evidenced by more than 6 episodes of loose stools, all of
them bloody, during a 24-hour period within the prior 7 days, concurrent with any of
the following systemic features:
- 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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Drug: Basiliximab
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Primary Outcome(s)
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Assess the safety of basiliximab in subjects with ulcerative colitis
[Time Frame: 1 year]
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Secondary Outcome(s)
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Evaluate the efficacy and assess the immunogenicity of t his multiple-dose maintenance regimen in this population
[Time Frame: 1 year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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