Clinical Trials Logo

Clinical Trial Summary

This study is a multi-center, Phase 2, open-label, 1-period, parallel study with 9 cohorts of subjects with OA of the knee enrolled to receive single-dose of TLC599 or DSP via IA injection and 1 cohort of healthy subjects to receive single-dose of DSP via IV injection.


Clinical Trial Description

This Phase 2, open-label, 1 period, parallel study will enroll 1. approximately 90 subjects to receive a single dose of TLC599 or DSP via IA injection, followed by a PK evaluation period up to 24 weeks and an additional follow-up period of 1 to 5 weeks. Additional subjects may be recruited as needed to achieve at least 10 subjects completing the 1-week blood collection period for each treatment. 2. approximately 12 healthy subjects to recieve a single dose of DSP via IV injection, followed by a PK evaluation period up to 1 week and an additional follow-up period of 1 week. Additional subjects may be recruited as needed to achieve at least 12 subjects completing the 48-hour blood collection period for IV DSP. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03754049
Study type Interventional
Source Taiwan Liposome Company
Contact
Status Completed
Phase Phase 2
Start date January 21, 2019
Completion date November 7, 2023

See also
  Status Clinical Trial Phase
Completed NCT03277066 - A 4-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Knee Osteoarthritis Phase 2
Recruiting NCT03090698 - Outcomes of Injections in Patients Waiting for Total Knee Replacement Phase 4
Completed NCT02556710 - A Study to Evaluate the Efficacy & Safety of an Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee Phase 3
Completed NCT02242435 - A Multiple Injection Study Evaluating Safety and Efficacy of Ampion in Osteoarthritis Phase 3
Withdrawn NCT02237846 - Clinical Study of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC) for Treatment of Osteoarthritis Phase 1/Phase 2
Completed NCT02096393 - Patient Specific Instrumentation in TKR N/A
Completed NCT01849445 - Targeted Rehabilitation to Improve Outcome After Knee Replacement- A Physiotherapy Study N/A
Completed NCT01704157 - A Prospective Study Evaluating the Treatment of Knee Osteoarthritis With the Cryo-Touch III Device N/A
Active, not recruiting NCT01374230 - Long-Term Multicenter Evaluation of the E1® Tibial Bearing N/A
Completed NCT02156440 - Cross-over Study of the Efficacy and Safety of SierraSil Joint Formula 14 in Osteoarthritis of the Knee Phase 2
Completed NCT01410409 - Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement N/A
Not yet recruiting NCT01270412 - Platelet Rich Plasma (PRP) as a Treatment for Knee Osteoarthritis PRP as a Treatment for Knee Osteoarthritis Phase 2/Phase 3
Completed NCT01207115 - A Study of ABT-652 in Adults With Osteoarthritis Pain of the Knee Phase 2
Completed NCT00988091 - Investigation of 1.2% Sodium Hyaluronate for Treatment of Painful Chronic Osteoarthritis of the Knee Phase 3
Completed NCT00970008 - Exploring Massage Benefits for Arthritis of the Knee Phase 2
Completed NCT01331278 - A Comparative Study of Knee Systems Phase 4
Completed NCT00531427 - Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee Phase 3
Completed NCT00792727 - HKT-500 in Adult Patients With Osteoarthritis (OA) Knee Pain Phase 3
Completed NCT00449696 - Gel-200 Versus Placebo in Osteoarthritis of the Knee Phase 3
Completed NCT04145011 - Coolief Cooled Radiofrequency vs. Conventional Radiofrequency to Manage OA Knee Pain N/A