Otsuka Holdings Co., Ltd.: Tuberculosis trials

The registry lists 10 Tuberculosis studies with Otsuka Holdings Co., Ltd. as lead sponsor. 1 are open to participants now and 6 have results posted.

Phase 1 2Phase 2 5Phase 3 1No phase 2(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• Registry on the Effectiveness and Safety of the 9-month MDR-END Treatment Regimen in Korean Patients with FQ-sensitive MDR-TB (MDR-END Registry)Not yet recruitingNCT06674291
• A Study to Test the Effects of Itraconazole and Carbamazepine on OPC-167832 in Healthy Men and WomenCompletedNCT07542847Phase 1Results posted
• A Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683CompletedNCT02573350Phase 2Results posted
• A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)CompletedNCT01859923Phase 2Results posted
• Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant TuberculosisCompletedNCT01424670Phase 3Results posted
• Safety and Pharmacokinetics (PK) in Multidrug-Resistant (MDR) Refractive TuberculosisTerminatedNCT01131351Phase 2Results posted
• A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB)CompletedNCT00685360Phase 2Results posted
• Post Marketing Registry to Assess Usage, Safety and Effectiveness of Deltyba Tablets in Korean Patients With MDR-TBCompletedNCT03470233
• Pharmacokinetic and Safety Trial to Determine the Appropriate Dose for Pediatric Patients With Multidrug Resistant TuberculosisCompletedNCT01856634Phase 1
• Safety, Efficacy and Pharmacokinetics of OPC-67683 in Patients With Pulmonary TuberculosisCompletedNCT00401271Phase 2