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A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of rhuMAb Beta7 in Patients With 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: NCT00694980
Recruitment Status : Completed
First Posted : June 11, 2008
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE June 7, 2008
First Posted Date  ICMJE June 11, 2008
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE September 2008
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2009)
  • Incidence and nature of laboratory abnormalities [ Time Frame: Through study completion or early study discontinuation ]
  • Incidence, nature, and severity of adverse events [ Time Frame: Through study completion or early study discontinuation ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 7, 2008)
  • Incidence, nature, and severity of adverse events
  • Incidence and nature of laboratory abnormalities
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2009)
  • PK profile and parameters [ Time Frame: Through study completion or early study discontinuation ]
  • Incidence of antibodies directed against rhuMAb Beta7 [ Time Frame: Through study completion or early study discontinuation ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2008)
  • PK profile and parameters
  • Incidence of antibodies directed against rhuMAb Beta7
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of rhuMAb Beta7 in Patients With Ulcerative Colitis
Official Title  ICMJE A Phase I, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Intravenous and Subcutaneous rhuMAb Beta7 Administered in a Single-Dose, Dose-Escalation Stage Followed by a Multidose, Parallel-Treatment Stage in Patients With Ulcerative Colitis
Brief Summary This is a randomized , double-blind, placebo-controlled study of approximately 70 patients with ulcerative colitis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Drug: placebo
    Intravenous and subcutaneous escalating doses
  • Drug: rhuMAb Beta7
    Intravenous and subcutaneous escalating doses
Study Arms  ICMJE Experimental: 1
Interventions:
  • Drug: placebo
  • Drug: rhuMAb Beta7
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 Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2012)
48
Original Estimated Enrollment  ICMJE
 (submitted: June 7, 2008)
70
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Able and willing to provide written informed consent
  • 18-70 years of age
  • Males and females with reproductive potential: Willing to use a reliable method of contraception
  • Diagnosis of ulcerative colitis
  • Eligible to receive biologic therapy
  • Disease duration of >=12 weeks

Exclusion Criteria:

  • Requirement for hospitalization due to severity of ulcerative colitis
  • Moderate to severe anemia
  • Any manifestation of ulcerative colitis or other conditions likely to require, in the investigator's judgment, treatment with >20 mg/day of prednisone, or prednisone equivalent, during the course of the study
  • Pregnant or lactating
  • Lack of peripheral venous access
  • Inability to comply with study protocol
  • History or presence of contraindicated diseases
  • Congenital immune deficiency
  • Active or prior infection with HIV or hepatitis B or C
  • History of severe systemic bacterial, fungal, viral, or parasitic infections
  • History of any other opportunistic infections within 12 weeks prior to initiation of study treatment
  • Received a live attenuated vaccine within 4 weeks prior to screening
  • Hospitalized within 4 weeks prior to screening
  • Received any contraindicated therapy within 12 weeks prior to screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 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 Belgium,   Canada,   Germany,   Netherlands,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00694980
Other Study ID Numbers  ICMJE ABS4262g
GA00930 ( Other Identifier: Hoffmann-La Roche )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date November 2016

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