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Basiliximab Maintenance in Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01061996
Recruitment Status : Terminated (lack of efficacy)
First Posted : February 4, 2010
Last Update Posted : February 4, 2010
Sponsor:
Information provided by:
Cerimon Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE February 2, 2010
First Posted Date  ICMJE February 4, 2010
Last Update Posted Date February 4, 2010
Study Start Date  ICMJE July 2007
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2010)
Assess the safety of basiliximab in subjects with ulcerative colitis [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2010)
Evaluate the efficacy and assess the immunogenicity of t his multiple-dose maintenance regimen in this population [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Basiliximab Maintenance in Ulcerative Colitis
Official Title  ICMJE An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis
Brief Summary

Primary Objective Safety: assess the safety of basiliximab 40 mg, given every 4 weeks, in subjects with ulcerative colitis who completed previous basiliximab studies.

Secondary Objectives: evaluate the efficacy and assess the immunogenicity of this multiple-dose maintenance regimen in this population

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE Drug: 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 Name: Simulect
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Basiliximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 2, 2010)
88
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01061996
Other Study ID Numbers  ICMJE BSX-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shaily J. Reichert, Cerimon Pharmaceuticals, Inc.
Study Sponsor  ICMJE Cerimon Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Shaily J. Reichert Cerimon Pharmaceuticals
PRS Account Cerimon Pharmaceuticals
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP