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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03769662
Registration number
NCT03769662
Ethics application status
Date submitted
6/12/2018
Date registered
7/12/2018
Date last updated
18/01/2020
Titles & IDs
Public title
Follow on Extension of XT-150-1-0201
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Scientific title
XT-150-1-0201 Extension: Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Osteoarthritic Pain
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Secondary ID [1]
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XT-150-1-0203
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Knee
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - XT-150
Experimental: High dose from study XT-150-1-0201 - Open label administration of the highest dose in the earlier study, in which all doses were well tolerated
Other interventions: XT-150
IL-10 transgene DNA plasmid injected into the knee synovial capsule
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of Treatment-Emergent Adverse Events
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Assessment method [1]
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Clinical Pathology, adverse events
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Timepoint [1]
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6 months
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Secondary outcome [1]
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Verbal Numeric Rating Score
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Assessment method [1]
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Pain scale from 1 to 10, 10 being worst possible
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Timepoint [1]
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6 months
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Secondary outcome [2]
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KOOS
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Assessment method [2]
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Osteoarthritis pain, symptoms, impact on daily living, and quality of life. Subset scores are calculated such that 100% is normal function
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Timepoint [2]
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6 months
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Secondary outcome [3]
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Brief Pain Inventory
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Assessment method [3]
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Pain and interference on daily living functions. Scales ranges from 0 to 10, with 10 being the worst
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Timepoint [3]
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6 months
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Secondary outcome [4]
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Clinical Global Improvement
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Assessment method [4]
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0 - 7 Scale, 4 and below indicate no change or improvement. Over 4 indicates degrees of worsening
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Timepoint [4]
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6 months
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Eligibility
Key inclusion criteria
1. Qualified and participated in clinical study XT-150-1-0201.
1. Participant was assigned to placebo, or
2. Participant elects to have XT-150 administered to the XT-150-untreated knee that
qualified under XT-150-1-0201 criteria, or
3. Participant had inadequate pain relief and elects to receive a second injection
to the same knee treated on clinical study XT-150-1-0201
2. Sufficiently severe OA of knee to require/have recommended knee replacement surgery or
be unsuitable for knee replacement surgery based on co-morbidities or orthopedic
considerations; be free of local or intra-articular infection.
3. Symptomatic disease because of osteoarthritis, defined as a Verbal Numerical Rating
Scale (VNRS) scores of a worst pain of at least 7 at any time during the preceding
week (based on scale of 0 to 10, with 10 representing "pain as bad as you can
imagine").
4. Stable analgesic regimen during the 4 weeks prior to enrollment.
5. Inadequate pain relief (minimum = 5 mean on Brief Pain Inventory-Severity Scale)
lasting more than 3 months.
6. In the judgment of the Investigator, acceptable general medical condition
7. Life expectancy >6 months
8. Male participants who are heterosexually active and not surgically sterile must agree
to use effective contraception, including abstinence, for the duration of the study
and for 3 months after the study is completed.
9. Have suitable knee joint anatomy for intra-articular injection
10. Willing and able to return for the follow-up (FU) visits
11. Able to reliably provide pain assessment
12. Able to read and understand study instructions, and willing and able to comply with
all study procedures
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Hypersensitivity, allergy, or significant reaction to any ingredient of the study
drug, including double-stranded DNA, mannose, and sucrose
2. Scheduled knee replacement within 4 months; participant agrees not to schedule a knee
replacement appointment within 4 months of study treatment
3. History of rheumatoid arthritis of the knee or gout.
4. High peri-operative risks which in the judgment of the investigator preclude a safe
knee injection procedure (e.g., poorly controlled diabetes, cardiac inadequacy such as
NYHA class > II, G4 glomerular filtration rate [eGFR < 30 mL/min by Cockcroft-Gault])
5. Current treatment with immunosuppressive (systemic corticosteroid therapy [equivalent
to >10mg/day prednisone] or other strong immunosuppressant)
6. History of immunosuppressive therapy; high-potency systemic steroids in the last 3
months.
7. Currently receiving systemic chemotherapy or radiation therapy for malignancy
8. Clinically significant hepatic disease as indicated by clinical laboratory results =3
times the upper limit of normal for any liver function test (e.g., aspartate
aminotransferase, alanine aminotransferase, lactate dehydrogenase)
9. Severe anemia (Grade 3; hemoglobin <8.0 g/dL, <4.9 mmol/L, <80 g/L; transfusion
indicated), uncontrolled coagulopathy (Grade 1, prolonged activated partial
prothrombin time (aPTT) > upper limit of normal (ULN) to 1.5xULN), or bleeding
diathesis, Grade 1 white cell counts (lymphocytes <LLN - 800/mm3; <LLN - 0.8 x 109 /L,
neutrophils <LLN - 1500/mm3; <LLN - 1.5 x 109 /L)
10. Significant neuropsychiatric conditions; dementia, major depression, or altered mental
state that in the opinion of the Investigator will interfere with study participation
11. Current treatment with systemic antibiotics or antivirals (EXCEPTION: topical
treatments)
12. Current treatment with anticoagulants, other than low-dose aspirin.
13. Known or suspected history of active alcohol or intravenous/oral drug abuse within 1
year before the screening visit
14. Women of child-bearing potential
15. Use of any investigational drug, other than XT-150, or device within 1 month before
enrollment or current participation in a trial that included intervention with a drug
or device; or currently participating in an investigational drug or device study.
16. Any condition that, in the opinion of the Principal Investigator, could compromise the
safety of the participant, the participant's ability to communicate with the study
staff, or the quality of the data
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/03/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/12/2019
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Sample size
Target
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Accrual to date
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Final
16
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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CMAX Clinical Research Pty Ltd in collaboration with University of Adelaide - Adelaide
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Recruitment postcode(s) [1]
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5005 - Adelaide
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Xalud Therapeutics, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
XT-150 safety and efficacy in severe osteoarthritic pain.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03769662
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mark Rickman, MD
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Address
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University of Adelaide
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03769662
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