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Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)

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ClinicalTrials.gov Identifier: NCT00307827
Recruitment Status : Terminated (Study Canceled)
First Posted : March 28, 2006
Last Update Posted : April 27, 2012
Sponsor:
Information provided by (Responsible Party):
Abbott

Tracking Information
First Submitted Date  ICMJE March 24, 2006
First Posted Date  ICMJE March 28, 2006
Last Update Posted Date April 27, 2012
Study Start Date  ICMJE April 2006
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2012)
Proportion of subjects in each of the three visilizumab dose groups who respond to treatment in the dose-exploration portion of this study (Stage 1). [ Time Frame: Day 45 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 24, 2006)
Clinical response
Change History Complete list of historical versions of study NCT00307827 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2012)
Comparison of subjects in the three visilizumab dose groups [ Time Frame: During the course of the study ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2006)
  • The secondary endpoints are the comparison of subjects in the three visilizumab dose groups in the following categories for the dose-exploration portion of the study
  • Clinical Remission
  • Mucosal healing
  • Symptomatic response and time to symptomatic response
  • Symptomatic remission
  • Durable clinical response
  • Time to disease progression
  • Colectomy rates
  • Time to colectomy
  • Ability to taper prednisone
  • Safety
  • Immunogenicity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
Official Title  ICMJE A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects With Intravenous Steroid-refractory Ulcerative Colitis
Brief Summary The purpose of this study is to assess the efficacy, immunogenicity, and safety of various doses of visilizumab in subjects with intravenous steroid-refractory ulcerative colitis (IVSR-UC) and to evaluate optimal dosing.
Detailed Description PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE Drug: Visilizumab
Visilizumab administered intravenously once per day for two days
Other Name: Nuvion®; HuM291
Study Arms  ICMJE
  • Experimental: Arm 1
    Visilizumab low dose level
    Intervention: Drug: Visilizumab
  • Experimental: Arm 2
    Visilizumab middle dose level
    Intervention: Drug: Visilizumab
  • Experimental: Arm 3
    Visilizumab high dose level
    Intervention: Drug: Visilizumab
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: April 26, 2012)
38
Original Enrollment  ICMJE
 (submitted: March 24, 2006)
100
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria:

  • Males and females, 18 years of age or older.
  • Diagnosis of ulcerative colitis (UC), as verified by endoscopy performed within 60 months prior to consent.
  • Severe active disease, as defined by modified Truelove Witts severity index (MTWSI) >= 11 at consent, with a confirmatory MTWSI >= 10 on or after the fifth consecutive day of intravenous (IV) steroids and within 1 day prior to randomization.
  • Mayo score >= 10 and Mayo mucosal subscore >= 2 after a minimum of 3 consecutive days (ie, on or after the fourth consecutive day) of IV steroids.
  • Adequate contraception from the day of consent through 3 months after the last dose of study drug.
  • Negative serum pregnancy test at screening.
  • Negative Clostridium difficile test within 10 days prior to randomization.
  • Signed and dated informed consent and Health Insurance Portability and Accountability Act (HIPAA) if applicable.

Exclusion Criteria

Subjects will be ineligible for this study if they meet any one of the following criteria:

  • UC requiring immediate intervention.
  • History of total proctocolectomy, or subtotal colectomy with ileorectal anastomosis
  • Presence of ileostomy.
  • White blood cell count less than 2.5 x 10^3/mcL; platelet count less than 150 x 10^3/mcL; or hemoglobin level less than 8 g/dL.
  • Active medically significant infections, particularly those of viral etiology, eg, known cytomegalovirus (CMV) colitis. This includes any incidence of medically significant opportunistic infections within the past 12 months.
  • Live vaccination within 6 weeks prior to randomization.
  • Significant organ dysfunction, including cardiac, renal, liver, central nervous system (CNS), pulmonary, vascular, gastrointestinal, endocrine, or laboratory abnormality.
  • History or treatment of lymphoproliferative disorder (LPD) or malignancy within the past 5 years (excluding nonmelanoma skin cancer or carcinoma in situ of the cervix).
  • Seropositivity for infection with human immunodeficiency virus (HIV-1), hepatitis B virus (HBV) surface antigen, or hepatitis C virus (HCV).
  • Pregnancy or nursing.
  • Treatment with a first dose of infliximab or another anti-TNF-a drug within 4 weeks of randomization, or treatment with a subsequent dose of an anti-TNF-a drug within 2 weeks of randomization.
  • Treatment with cyclosporine or tacrolimus (FK506) within 2 weeks prior to randomization.
  • Treatment with any other investigational drugs or therapies within 60 days prior to randomization, except those mentioned in the two exclusion criteria above.
  • Unwilling or unable to discontinue all UC drugs, except glucocorticoids and oral 5-ASA, immediately prior to randomization.
  • Nontherapeutic levels of chronic antiseizure medications in subjects with a prior history of seizures.
  • Any condition that, in the investigator's opinion, makes the subject unsuitable for study participation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Canada,   Croatia,   Italy,   Russian Federation,   Spain,   United States
Removed Location Countries Ireland,   Switzerland
 
Administrative Information
NCT Number  ICMJE NCT00307827
Other Study ID Numbers  ICMJE 291-418
2005-003482-17 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbott
Study Sponsor  ICMJE Abbott
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mihail Obrocea, MD Abbott
PRS Account Abbott
Verification Date April 2012

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