NCT01580670

Clinical Study of TA-650 in Pediatric Patients With Crohn's Disease

Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Pediatric Patients With Moderate to Severe Crohn's Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 14 (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 efficacy of TA-650 using Pediatric Crohn's Disease Activity Index (PCDAI) in pediatric patients with moderate to severe Crohn's disease after TA-650 administration at a dose of 5 mg/kg at week 0, 2, and 6, then every 8 week after week 14 up to week 46, and at a dose of 10 mg/kg if the effect is attenuated. The safety and pharmacokinetics are also evaluated.

Detailed description

This is an open-label, uncontrolled, multicenter Phase 3 study conducted in Japan.

Conditions

• Pediatric Crohn's Disease

Interventions

Type	Name	Description
DRUG	TA-650	TA-650 will be intravenously infused at 5 mg/kg as an induction regimen at Week 0, 2, 6. For subjects who meet the responder criteria, TA-650 will be administered at 8-week intervals thereafter until week 46. If the criteria for a dosage escalation are met, TA-650 will be administered at a dosage of 10 mg/kg.

Timeline

• Start date: 2012-03-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2012-04-19
• Last updated: 2026-01-07
• Results posted: 2019-07-05

Locations

7 sites across 1 country: Japan