NCT01585155

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pediatric Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	TA-650	TA-650 will be intravenously infused at 5 mg/kg as an induction regimen at Weeks 0, 2, 6. For subjects who meet the responder criteria, TA-650 will be administered at 8-week intervals thereafter until week 22.

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2012-04-25
• Last updated: 2026-01-07
• Results posted: 2019-10-21

Locations

7 sites across 1 country: Japan