At a glance
ClinicalIndex Comparison RecordN/ACompleted· 65 enrolled
Drug / intervention
Hydrous biopolymer with silver ions "Argiform" (HBISA) endoprosthesis of synovial fluid NOLTREX™device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label Multicenter Postmarketing Extension Study of Efficacy and Safety of Intra-articular HBISA Endoprosthesis of Synovial Fluid NOLTREX™ in Knee Osteoarthritis
In Brief
A clinical study evaluating Hydrous biopolymer with silver ions "Argiform" (HBISA) endoprosthesis of synovial fluid NOLTREX™ for Osteoarthritis. Completed, enrolled 65 participants across 4 sites.
Detailed Summary
The OLE was aimed to assess long-term safety and efficacy of one and two courses of IA HBISA in patients with knee osteoarthritis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis
CountriesRussia
Collaborators--
Timeline
N/ACompletedFinished
202120222023202420252026
Enrollment StartMay 2020
Primary CompletionDec 2020
Study CompletionMay 2021
First PostedMay 2024
TodayJul 2026
First PostedMay 24, 2024
Enrollment StartMay 28, 2020
Primary CompletionDec 28, 2020
Study CompletionMay 12, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 2.1 years ago
Interventions
Hydrous biopolymer with silver ions "Argiform" (HBISA) endoprosthesis of synovial fluid NOLTREX™device
If clinically indicated patients received a repeat course of NOLTREX™ (one or two weekly intra-articular injections of 4.0 NOLTREX™ at the investigator's discretion depending on the stage of OA and clinical response to treatment).