Clotting Disorders Clinical Trial
Official title:
Mobius PT-INR Accuracy Clinical Study
| Verified date | June 2011 |
| Source | Universal Biosensors Pty Ltd |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this study is to measure prothrombin time (PT) expressed in International Normalised Ratio (INR) units in persons receiving coumadin (warfarin) treatment on an experimental device and a commercially available device. This study will involve taking a finger-puncture and testing onto a strip and meter system for the experimental and commercially available devices.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | September 2010 |
| Est. primary completion date | September 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Are currently taking coumadin (warfarin) - Are aged 18 years or older - Able and willing to provide informed consent - Can understand (read and write) English - Required to provide a capillary sample as part of their routine medical check Exclusion Criteria: - Previously participated in this study |
| Country | Name | City | State |
|---|---|---|---|
| United States | White River Diagnostic Clinic | Batesville | Arkansas |
| Lead Sponsor | Collaborator |
|---|---|
| Universal Biosensors Pty Ltd |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | PT/INR values from the experimental device will be statistically correlated to results obtained from a commercially available device | To determine the correlation of PT/INR values between an experimental and commercial device | Five days to collect data and up to two weeks to generate correlation graph |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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