Status:
TERMINATED
Long-Term Follow-Up Study of Patients With Osteoarthritis of the Knee Treated With UBX0101 or Placebo
Lead Sponsor:
Unity Biotechnology, Inc.
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40-85 years
Brief Summary
A follow-up study to assess the long-term safety of intra-articular (IA) administration of UBX0101 in patients with painful knee osteoarthritis (OA).
Detailed Description
This is a blinded, multi-center study to provide approximately 1 additional year of follow-up for patients with knee OA who participated in a randomized placebo-controlled study of IA UBX0101. No inte...
Eligibility Criteria
Inclusion
- Patients with knee OA who have completed a randomized placebo-controlled study of UBX0101.
- Patients who are willing and able to consent to having blinded, long-term follow-up; consent via legally authorized representative is not accepted.
Exclusion
- Patients with any condition that, in the opinion of the Investigator, would likely interfere with adhering to the study schedule of visits for 12 months.
- Patients who are scheduled to undergo knee arthroplasty on either knee during the study.
- Patients who anticipate arthroscopic surgery on either knee at any time during the study.
- Patients who plan to receive treatment with an anti-nerve growth factor agent during the study.
- Patients who plan to participate in another investigational study (including interventional studies of investigational drugs and investigational treatments \[e.g., braces, stem cells, and procedures\]) during the study.
Key Trial Info
Start Date :
April 20 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 2 2020
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT04349956
Start Date
April 20 2020
End Date
November 2 2020
Last Update
November 17 2020
Active Locations (17)
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1
Coastal Clinical Research, LLC.
Mobile, Alabama, United States, 36608
2
Fiel Family and Sports Medicine
Tempe, Arizona, United States, 85283
3
Tucson Orthopaedic Institute
Tucson, Arizona, United States, 85712
4
Biosolutions Clinical Research Center
La Mesa, California, United States, 91942