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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:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00694980
First received: June 7, 2008
Last updated: September 1, 2016
Last verified: September 2016
History of Changes
  Purpose
This is a randomized , double-blind, placebo-controlled study of approximately 70 patients with ulcerative colitis.

Condition Intervention Phase
Ulcerative Colitis
 Drug: placebo
Drug: rhuMAb Beta7
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Incidence and nature of laboratory abnormalities [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • Incidence, nature, and severity of adverse events [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PK profile and parameters [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • Incidence of antibodies directed against rhuMAb Beta7 [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
Enrollment: 48
Study Start Date: September 2008
Study Completion Date: September 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: placebo
Intravenous and subcutaneous escalating doses
Drug: rhuMAb Beta7
Intravenous and subcutaneous escalating doses

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694980

  Show 30 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00694980     History of Changes
Other Study ID Numbers: ABS4262g  GA00930 
Study First Received: June 7, 2008
Last Updated: September 1, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
UC
Ulcerative Colitis

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases

ClinicalTrials.gov processed this record on September 29, 2016