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Clinical Study of TA-650 in Pediatric Patients With Ulcerative Colitis | Clinical Trials | Clareo Health

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Clinical Study of TA-650 in Pediatric Patients With Ulcerative Colitis

Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Pediatric Patients With Moderate to Severe Ulcerative Colitis.

NCT01585155•Tanabe Pharma Corporation

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the the efficacy of TA-650 using Clinical activity index (CAI) score and other evaluation indicators in pediatric patients with moderate to severe ulcerative colitis after TA-650 administration of at a dose of 5 mg/kg at weeks 0, 2, and 6, and then every 8 weeks at weeks 14 and 22. The safety and pharmacokinetics are also evaluated.

Eligibility

Age

6 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients who have been diagnosed as ulcerative colitis at least 3 months prior to screening.
•Have active ulcerative colitis despite adequate conventional therapy.

Exclusion Criteria

•Patients who have severe pancolitis.
•Patients who have undergone surgery for ulcerative colitis within 8 weeks before enrollment or who were judged to require surgery for ulcerative colitis at enrollment.
•Patients who have a history of treatment with infliximab or other biologic products (anti-TNFα agents, anti-IL-6 agents, etc.).

Locations (7)

Investigational site

Chūbu, Japan

Investigational site

Hokkaido, Japan

Investigational site

Hokuriku, Japan

Investigational site

Kanto, Japan

Investigational site

Kinki, Japan

Investigational site

Kyusyu, Japan

Investigational site

Tōhoku, Japan

Key Dates

Start Date

February 1, 2012

Primary Completion Date

September 1, 2014

Completion Date

September 1, 2014

Last Updated

January 7, 2026

Enrollment

ACTUAL participants

Conditions

Pediatric Ulcerative Colitis

Interventions

TA-650

DRUG