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TLC599 for Knee Osteoarthritis
Phase 2
Waitlist Available
Research Sponsored by Taiwan Liposome Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has symptoms associated with OA of the knee for at least 6 months prior to Screening and confirmation of mild to moderate OA
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening till 25 weeks post ip administration
Awards & highlights
Study Summary
This trial studies a single dose of new treatments for knee OA in 9 groups of people with OA, plus 1 group of healthy people.
Eligible Conditions
- Osteoarthritis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have experienced symptoms of knee OA for a minimum of 6 months, and your condition has been verified as mild to moderate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening till 25 weeks post ip administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening till 25 weeks post ip administration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area under the Curve [AUC]
Cmax: maximum concentration
Tmax: time to peak concentration
Secondary outcome measures
Hydrocortisone
Number of AEs, including SAE and treatment-emergent AE
Side effects data
From 2016 Phase 1 & 2 trial • 40 Patients • NCT028033075%
Pruritus
5%
Arrhythmia
5%
Pyrexia
5%
Influenza
5%
Upper respiratory tract infection
5%
Urinary tract infection
5%
Hyperlipidaemia
5%
Dizziness
5%
Hypertension
5%
Rhinitis allergic
5%
Rhinorrhoea
5%
Dermatitis contact
100%
80%
60%
40%
20%
0%
Study treatment Arm
6 mg TLC599
12 mg TLC599
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: TLC599 6 mgExperimental Treatment1 Intervention
6 mg DSP with 50 μmol phospholipid via IA injection.
Group II: TLC599 12 mgExperimental Treatment1 Intervention
12 mg DSP with 100 μmol phospholipid via IA injection;
Group III: DSP 10mgActive Control1 Intervention
Dexamethasone Sodium Phosphate (DSP): 4 mg/mL, 2.5 mL via IV injection.
Group IV: DSP 4mgActive Control1 Intervention
Dexamethasone Sodium Phosphate (DSP): 4 mg/mL, 1 mL via IA injection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TLC599
2019
Completed Phase 3
~650
Find a Location
Who is running the clinical trial?
Taiwan Liposome CompanyLead Sponsor
17 Previous Clinical Trials
1,617 Total Patients Enrolled
3 Trials studying Osteoarthritis
623 Patients Enrolled for Osteoarthritis
Terry Tai, MDStudy DirectorTaiwan Liposome Company
Carl Brown, PhDStudy DirectorTaiwan Liposome Company
9 Previous Clinical Trials
1,323 Total Patients Enrolled
2 Trials studying Osteoarthritis
546 Patients Enrolled for Osteoarthritis
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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