A pilot study to investigate the effects of pentosan polysulfate sodium in Ross River virus induced arthralgia
- Conditions
- Ross River Virus induced arthralgiaMusculoskeletal - Other muscular and skeletal disordersInflammatory and Immune System - Other inflammatory or immune system disorders
- Registration Number
- ACTRN12617000893303
- Lead Sponsor
- Paradigm Biopharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
1.Males and females aged 18 - 65 years (inclusive)
2.Diagnosis of Ross River virus infection based on laboratory definitive or laboratory suggestive diagnosis according to Australian Government Ross River virus case definition
3.Current Ross River virus symptoms including a minimum of 2 joints involved (swollen and/or tender joint on examination)
4.Medically documented onset of RRV infection symptoms minimum 12 weeks and maximum 52 weeks prior to Day 1
5.Able to speak, read and understand English sufficiently to understand the purposes and risks of the study and to provide written informed consent
6.If applicable, subjects must be willing to comply with the medically acceptable contraceptive requirements of the study from Screening to at least 28 days after the last IMP administration
7.Body Mass Index (BMI) of 18.0 to 35.0 kg/m2 (inclusive)
Subjects must be willing and able to comply with all scheduled visits, treatment plan, laboratory tests and other study procedures
1.Documented or reported bleeding tendency with anticoagulant or antiplatelet drugs
2.Current treatment with anticoagulants or antiplatelet drugs
3.Subject taking any current or recent medication specified as per Prohibited Medications for this study.
4.Subject unwilling to withhold paracetamol and alcohol for 24 hours prior to study assessment visits
5.Any clinically significant abnormalities not related to RRV infection on clinical chemistry, haematology, urinalysis, physical examination, medical history, 12-lead ECG, or vital signs as judged by the investigator or sponsor (at Screening and/or Day 1)
6.Coagulation parameters or platelets outside normal range at Screening and/or Day 1
7.Evidence of any active or clinically significant chronic condition including autoimmune disease involving the musculoskeletal system
8.Current evidence or recent history of other arthrogenic virus infection
9.Blood or plasma donation of more than 500 mL during the 3 months prior to Day 1
10.Currently hospitalised or any planned hospitalisations during the study period
11.Participation in another clinical trial or administration of any investigational agent within 8 weeks or 5 half-lives (whichever is longer) prior to Day 1
12.Currently active or recent history (within previous 12 months) of a gastric or duodenal ulcer, or suspicion of alimentary tract bleeding
13.History of significant hypersensitivity to PPS or drugs of a similar chemical or pharmacological class, including a history of heparin induced thrombocytopenia
14.Females who are breast feeding, pregnant or planning to become pregnant during participation in the study
15.Major surgery within 3 months prior to Day 1 or anticipated surgery in the study period
16.History of or current clinically-significant gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, oncological, immunological, neurological, ophthalmological, haematological or psychiatric disorder or any other condition, which in the opinion of the investigator or sponsor would jeopardize the safety of the subject or the validity of the study results
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method