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A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of rhuMAb Beta7 in Patients With Ulcerative Colitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00694980
First Posted: June 11, 2008
Last Update Posted: November 2, 2016
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.
Information provided by (Responsible Party):
Genentech, Inc.
June 7, 2008
June 11, 2008
November 2, 2016
September 2008
September 2011   (Final data collection date for primary outcome measure)
  • 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 ]
  • Incidence, nature, and severity of adverse events
  • Incidence and nature of laboratory abnormalities
Complete list of historical versions of study NCT00694980 on ClinicalTrials.gov Archive Site
  • 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 ]
  • PK profile and parameters
  • Incidence of antibodies directed against rhuMAb Beta7
Not Provided
Not Provided
 
A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of rhuMAb Beta7 in Patients With Ulcerative Colitis
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
This is a randomized , double-blind, placebo-controlled study of approximately 70 patients with ulcerative colitis.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Ulcerative Colitis
  • Drug: placebo
    Intravenous and subcutaneous escalating doses
  • Drug: rhuMAb Beta7
    Intravenous and subcutaneous escalating doses
Experimental: 1
Interventions:
  • Drug: placebo
  • Drug: rhuMAb Beta7
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
September 2012
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Germany,   Netherlands,   United Kingdom,   United States
 
 
NCT00694980
ABS4262g
GA00930 ( Other Identifier: Hoffmann-La Roche )
Not Provided
Not Provided
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
November 2016

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