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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Genentech

ClinicalTrials.gov Identifier:

NCT00694980

First received: June 7, 2008

Last updated: March 19, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 7, 2008

Last Updated Date

March 19, 2012

Start Date ^ICMJE

September 2008

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Incidence and nature of laboratory abnormalities
Incidence, nature, and severity of adverse events

Change History

Complete list of historical versions of study NCT00694980 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

PK profile and parameters
Incidence of antibodies directed against rhuMAb Beta7

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Arm (s)

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

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

November 2012

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, Canada, Germany, Netherlands, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00694980

Other Study ID Numbers ^ICMJE

ABS4262g, GA00930

Has Data Monitoring Committee

Not Provided

Responsible Party

Genentech

Study Sponsor ^ICMJE

Genentech

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Genentech

Information Provided By

Genentech

Verification Date

March 2012

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

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