A Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients
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ClinicalTrials.gov Identifier: NCT03037489 |
Recruitment Status :
Completed
First Posted : January 31, 2017
Results First Posted : March 18, 2019
Last Update Posted : March 18, 2019
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Sponsor:
Medivir
Information provided by (Responsible Party):
Medivir
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Tracking Information | ||||
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First Submitted Date ICMJE | December 22, 2016 | |||
First Posted Date ICMJE | January 31, 2017 | |||
Results First Submitted Date ICMJE | November 26, 2018 | |||
Results First Posted Date ICMJE | March 18, 2019 | |||
Last Update Posted Date | March 18, 2019 | |||
Actual Study Start Date ICMJE | September 2016 | |||
Actual Primary Completion Date | November 28, 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients [ Time Frame: Group A: 0-56 weeks; Group B: 0-30 weeks ]
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Original Primary Outcome Measures ICMJE |
Safety and tolerability of MIV-711 in OA patients [ Time Frame: 26 weeks ]
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Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients | |||
Official Title ICMJE | An Open-Label, One-Arm Phase II Extension Study to Evaluate Safety and Tolerability of MIV-711 in Patients With Knee Joint Osteoarthritis | |||
Brief Summary | This is a multicentre, open-label, one-arm Phase II extension study to evaluate the safety and tolerability of MIV-711 in patients with knee joint osteoarthritis (OA). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Osteoarthritis, Knee | |||
Intervention ICMJE | Drug: MIV-711
MIV-711 administered orally once daily
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Study Arms ICMJE | Experimental: MIV-711
MIV-711 for a total of 26 weeks
Intervention: Drug: MIV-711
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
50 | |||
Original Estimated Enrollment ICMJE |
80 | |||
Actual Study Completion Date ICMJE | November 28, 2017 | |||
Actual Primary Completion Date | November 28, 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: - Previously enrolled in the MIV-711-201 study including completion of Visit 8 either by
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 40 Years to 81 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Bulgaria, Georgia, Germany, Moldova, Republic of | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT03037489 | |||
Other Study ID Numbers ICMJE | MIV-711-202 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Responsible Party | Medivir | |||
Study Sponsor ICMJE | Medivir | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Medivir | |||
Verification Date | March 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |