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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03005873




Registration number
NCT03005873
Ethics application status
Date submitted
12/12/2016
Date registered
29/12/2016
Date last updated
19/09/2018

Titles & IDs
Public title
Phase IIa, Randomized, Double Blinded, Placebo Controlled, Dose Finding Study for TLC599 in OA Patients
Scientific title
A Phase IIa, Randomized, Double Blinded, Placebo Controlled, Dose Finding Study for Single Dose Administration of TLC599 in Patients With Osteoarthritis (OA) of Knee
Secondary ID [1] 0 0
TLC599A2003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TLC599 LD group
Treatment: Drugs - Normal Saline
Treatment: Drugs - TLC599 HD group

Experimental: TLC599 LD group - 12 mg DSP with 100 µmol PL (1.0 mL)

Experimental: TLC599 HD group - 18 mg DSP with 150 µmol PL (1.5 mL)

Placebo Comparator: Placebo group - 1.5 mL normal saline


Treatment: Drugs: TLC599 LD group
Single dose via intra-articular injection

Treatment: Drugs: Normal Saline
Single dose via intra-articular injection

Treatment: Drugs: TLC599 HD group
Single dose via intra-articular injection

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
WOMAC questionnaire pain sub-scale - The primary endpoint is to evaluate the change from baseline by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale through Week 12.
Timepoint [1] 0 0
from dosing through Week 12
Secondary outcome [1] 0 0
WOMAC questionnaire pain sub-scale - Change from baseline to Weeks 1, 4, 8, 12, 16, 20, and 24 in pain / function subscales of WOMAC.
Timepoint [1] 0 0
at Weeks 1, 4, 8, 12, 16, 20, and 24
Secondary outcome [2] 0 0
Pain score (VAS) - Change from baseline to Weeks 1, 4, 8, 12, 16, 20, and 24 in the patient rated visual analogue scale (VAS).
Timepoint [2] 0 0
at Weeks 1, 4, 8, 12, 16, 20, and 24
Secondary outcome [3] 0 0
Pain score (VAS) - Change from baseline through Weeks 12, 16, 20, and 24 in the patient rated visual analogue scale (VAS).
Timepoint [3] 0 0
from dosing through Week 12, 16, 20, 24
Secondary outcome [4] 0 0
WOMAC questionnaire pain sub-scale - Change from baseline through Weeks 12, 16, 20, and 24 in the patient rated visual analogue scale (VAS).
Timepoint [4] 0 0
from dosing through Week 12, 16, 20, 24
Secondary outcome [5] 0 0
EuroQol-5 Dimension questionnaire - Change from baseline to Weeks 1, 4, 8, 12, 16, 20, and 24 in EuroQol-5 Dimension questionnaire.
Timepoint [5] 0 0
at Weeks 1, 4, 8, 12, 16, 20, and 24
Secondary outcome [6] 0 0
Usage of acetaminophen - Total consumption of acetaminophen at Weeks 1, 4, 8, 12, 16, 20, and 24.
Timepoint [6] 0 0
at Weeks 1, 4, 8, 12, 16, 20, and 24
Secondary outcome [7] 0 0
Incidence of Treatment-Emergent Adverse Events - To evaluate the safety and tolerability of TLC599 by incidence of Treatment-Emergent Adverse Events reported by Investigators
Timepoint [7] 0 0
up to 24 weeks after dosing

Eligibility
Key inclusion criteria
Main

1. Male or female patients, at least 50 years of age.

2. Documented diagnosis of OA of the knee for at least 6 months

3. The study knee has OA with Grade 2 to 3 severity based on the Kellgren Lawrence grades

4. Patients with patient related visual analogue scale (VAS) score of 5.0 to 9.0 at
baseline.

5. Willing and able to comply with study procedures and provide written informed consent.

Main
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who received systemic corticosteroids within the last 30 days prior to
dosing.

2. Patients who use prohibited medications within 7 days prior to study drug
administration or any pain control medication including acetaminophen within 48 hours
prior to study drug administration.

3. Patients who use prohibited medications other than acetaminophen and oral NSAIDs from
screening visit to 7 days prior to study drug administration.

4. Documented history and confirmed autoimmune disease

5. History of post-traumatic knee arthritis, or evidence of intra articular bleeding of
the study knee

6. History of infective arthritis

7. Unstable study knee joint

8. Use of IA corticosteroid, hyaluronic acid, or other IA injection in the study knee
within 3 months prior to the screening visit.

9. A history of treated malignancy which is disease free for = 5 years prior to the
screening visit

10. Uncontrolled and unstable concurrent medical or psychiatric illness, that will
jeopardize the safety of the patient

11. Use of any chemotherapeutic or systemic immunosuppressant agents for inflammatory
diseases within 6 months prior to the screening visit.

12. Current use of anticoagulants, including warfarin, heparin, low molecular weight
heparin, or dabigatran.

13. Abnormalities of laboratory parameters as described below will qualify for exclusion:

- hemoglobin < 8 g/dL;

- total white blood cell count < 4000/ µL;

- serum bilirubin/ alanine aminotransferase/ aspartate aminotransferase > 2 times
upper limit of normal (ULN) for the laboratory reference ranges;

- serum creatinine > 2 times ULN for the laboratory reference range;

- serum uric acid > ULN for the laboratory reference range;

- prothrombin time/International Normalized Ratio > ULN for the laboratory
reference range.

14. Contraindication to undergoing magnetic resonance imaging (MRI)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Genesis Research Services Pty Limited - Broadmeadow
Recruitment hospital [2] 0 0
Pendlebury Clinic Private Hospital - Cardiff
Recruitment hospital [3] 0 0
Footscray Hospital- Western Health - Footscray
Recruitment hospital [4] 0 0
Linear Clinical Research Limited - Nedlands,
Recruitment hospital [5] 0 0
Royal North Shore Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Broadmeadow
Recruitment postcode(s) [2] 0 0
2285 - Cardiff
Recruitment postcode(s) [3] 0 0
- Footscray
Recruitment postcode(s) [4] 0 0
- Nedlands,
Recruitment postcode(s) [5] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Taiwan
State/province [1] 0 0
Changhua
Country [2] 0 0
Taiwan
State/province [2] 0 0
Kaohsiung
Country [3] 0 0
Taiwan
State/province [3] 0 0
Taichung
Country [4] 0 0
Taiwan
State/province [4] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Taiwan Liposome Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This trial is a Phase IIa, Randomized, Double blinded, Placebo controlled, Dose finding Study
to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee.
Trial website
https://clinicaltrials.gov/show/NCT03005873
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Yvonne Shih, PhD
Address 0 0
Taiwan Liposome Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications