OsteoarthritisNCT06429319
Intra-articular Polyacrylamide Hydrogel in Gonarthrosis
A study testing Hydrous biopolymer with silver ions "Argiform" (HBISA) endoprosthesis of synovial fluid NOLTREX™ in people with Osteoarthritis, run by Research Centre BIOFORM at 4 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Hydrous biopolymer with silver ions "Argiform" (HBISA) endoprosthesis of synovial fluid NOLTREX™
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 4 sitesRussia
- Study dates
- 28 May 2020to 12 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over 50 years of age;
- Provision of signed informed consent form;
- Patients met ACR classification criteria for knee osteoarthritis (pain in the knee and at least three of the following: age >50 years, stiffness <30 min, crepitus, bony tenderness, bony enlargement and no palpable warmth);
- OA grades 2 and 3 on the Kellgren-Lawrence scale with the predominant involvement of the medial tibiofemoral region of the knee joint;
- Patients from the NOLTREX™ group of the parent study (IA/PAAG-SI/OA/2019) who completed all (5) study visits
Who cannot join
- Pregnancy and breastfeeding;
- History of trauma or surgery on the target knee joint;
- Instability of the target knee joint;
- Microcrystalline arthropathies (according to the history and taking into account clinical manifestations);
- History of systemic inflammatory diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.);
- Seronegative spondyloarthritis and reactive arthritis;
Show all 24Show fewer
- Increased rheumatoid factor;
- Increased uric acid > 360 µmol/l;
- Intra-articular injection into the target knee joint:
- hyaluronates - within 12 months prior to patient enrollment in the study;
- other synovial fluid endoprostheses (except for NOLTREX™ in the IA/PAAG- SI/OA/2019 study) within 24 months;
- glucocorticoids - within 1 month before enrollment in the study;
- NSAIDs - intra-articular injection at any time in the history.
- Systemic pain medications (NSAIDs, opioid analgesics) within 1 week prior to Visit 0;
- Effusion in the target joint;
- The presence of inflammation or infection in the target joint, synovitis;
- The need for continuous use of glucocorticoids in any dosage form;
- Use of paracetamol within 48 hours prior to Visit 0;
- A positive blood test result for one or more of the following infections: HIV, hepatitis B and C, syphilis;
- Severe liver disease, defined as an increase in one of the following: ALT, AST, alkaline phosphatase, total bilirubin, GGT more than 3 times the upper limit of normal;
- Kidney disease with a glomerular filtration rate as assessed by the Cockcraft-Gault formula less than 60 mL/min/1.73 m2 (stages III-V chronic kidney disease [CKD]);
- Clinical manifest coxarthrosis;
- Severe decompensated chronic or acute diseases and other conditions or other causes that, in the investigator's opinion, may prevent the patient from participating in the study or affect the study results ;
- Participation in any other clinical trial except that IA/PAAG-SI/OA/2019 within 90 days prior to enrollment in the OLE.
Trial locations and contacts
4 sites in 1 country.
Russia4 sites
Non-budgetary healthcare facility "Railway clinical hospital n.a. Semashko N.A. at Lublino, OJSC "Russian Railways"
Moscow
"Clinical Diagnostic Center "Ultramed", LLC
Omsk
Private Healthcare Facilty "Clinical hospital "RZHD-Medicina" of the city Saint-Petersburg
Saint Petersburg
State budgetary healthcare facility of Yaroslavl Region "Clinical hospital №3"
Yaroslavl
About this study
Official title: An Open-label Multicenter Postmarketing Extension Study of Efficacy and Safety of Intra-articular HBISA Endoprosthesis of Synovial Fluid NOLTREX™ in Knee Osteoarthritis
The OLE was aimed to assess long-term safety and efficacy of one and two courses of IA HBISA in patients with knee osteoarthritis.
Read the detailed description
HBISA (polyacrylamide hydrogel) endoprosthesis of synovial fluid NOLTREX™ is intended for the symptomatic treatment of adult patients with osteoarthritis (OA) reducing pain and improving mobility.
The aim of the 6-month OLE was to evaluate the long-term safety and efficacy of one and two courses of IA Polyacrylamide hydrogel with silver ions in patients with knee osteoarthritis who had received at least one IA injection of NOLTREX™ and completed the visit 5 in the IA/PAAG-SI/OA/2019 study.
In OLE patients who had received a course of treatment (one or two weekly intra-articular injections of 4.0 NOLTREX™ depending on the stage of OA and the clinical response to treatment) in the parent study might receive a single repeat course of NOLTREX™ at the visits 1/2 or 3/4 when clinically indicated. The WOMAC was the primary outcome measure.
- Conditions
- Osteoarthritis
- Being tested
- Hydrous biopolymer with silver ions "Argiform" (HBISA) endoprosthesis of synovial fluid NOLTREX™
- Keywords
- intra-articular, polyacrylamide hydrogel, PAAG, HBISA (Hydrous biopolymer with silver ions "Argiform"), NOLTREX
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrous biopolymer with silver ions "Argiform" (HBISA) endoprosthesis of synovial fluid NOLTREX™Device
Also called Polyacrylamide hydrogel with silver ions
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).
| Study group | Role | What they receive |
|---|---|---|
| Medical Device: HBISA (polyacrylamide hydrogel) synovial fluid endoprosthesis NOLTREX™ | Other | Sixty-five (65) patients were included in the study and divided into three groups based on the number of NOLTREX™ courses received:
* Group A consisted of 5 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 1/2 of OLE (IA/PAAG-SI/OA/2020) study.
* Group B comprised 43 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 3/4 of OLE.
* Group C consisted of 17 patients who had received only 1 NOLTREX™ course in the parent study. Receives: Device: Hydrous biopolymer with silver ions "Argiform" (HBISA) endoprosthesis of synovial fluid NOLTREX™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Total WOMAC Score (WOMAC-T)
Mean change in WOMAC-T from baseline (visit 0 [screening] of OLE and visit 1 (week 1) of the parent study) to visit 3 (week 11) and visit 5 (week 23). Patients were asked to complete the questionnaire during the study visits. The Western Ontario and McMaster Universities Osteoarthritis Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100-mm VAS and consists of three subscales: pain (5 questions), stiffness (2 questions), and physical function (17 questions). The scores for each subscale are summed up, with a possible score range of 0-500 for Pain, 0-200 for Stiffness, and 0-1700 for Physical Function. Higher scores represent worse pain, stiffness, and functional limitations. A sum of the scores for all three subscales gives a total WOMAC score (0-2400), where 0 represents the best and 2400 the worst possible health status. The higher the score, the poorer the function. Therefore, an improvement was achieved by reducing the overall score.
Measured: baseline (OLE visit 0 and visit 1 study 1 [week 1]), OLE visits 3 (week 11) and 5 (week 23)
Secondary outcomes (9)
Change in the WOMAC Pain Score (WOMAC-A)
Mean change in WOMAC-A from baseline (visit 1 (week 1) of the parent study AND visit 0 [screening] of OLE) to visit 3 (week 11) and visit 5 (week 23). Patients were asked to complete the questionnaire during the study visits. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a set of standardized questionnaires used by health professionals to evaluate pain, stiffness and physical functioning of the joints in patients with knee and/or hip osteoarthritis. The WOMAC Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100 mm VAS. The WOMAC pain scale consists of five items: (1) walking on flat ground; (2) going up or down stairs; (3) at night while in bed; (4) sitting or lying; and (5) standing upright. The scores for the Pain subscale are summed up, with a possible score range of 0-500. Higher scores represent worse pain.
Measured: baseline (OLE visit 0 and visit 1 study 1 [week 1]), OLE visits 3 (week 11) and 5 (week 23)
Change in the WOMAC Stiffness (WOMAC-B) Score
Mean change in WOMAC-B from baseline (visit 0 [screening] of the OLE and visit 1 [week 1] of the parent study) to visits 3 (week 11) and 5 (week 23). Patients were asked to complete the questionnaire during the study visits. The Western Ontario and McMaster Universities Osteoarthritis Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100 mm VAS and consists of three subscales: pain (5 questions), stiffness (2 questions), and physical function (17 questions). The scores for each subscale are summed up, with a possible score range of 0-200 for Stiffness, and 0-1700 for Physical Function. Higher scores represent worse stiffness and functional limitations. The higher the score, the poorer the function. Therefore, an improvement was achieved by reducing the overall score.
Measured: baseline (OLE visit 0 and parent study visit 1 [week 1]), visits 3 (week 11) and 5 (week 23)
Change in the WOMAC Physical Function (WOMAC-C) Score
Mean change in WOMAC-C from baseline (visit 0 [screening] of the OLE and visit 1 [week 1] of the parent study) to visits 3 (week 11) and 5 (week 23). Patients were asked to complete the questionnaire during the study visits. The Western Ontario and McMaster Universities Osteoarthritis Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100 mm VAS and consists of three subscales: pain (5 questions), stiffness (2 questions), and physical function (17 questions). The scores for each subscale are summed up, with a possible score range of 0-200 for Stiffness, and 0-1700 for Physical Function. Higher scores represent worse stiffness and functional limitations. The higher the score, the poorer the function. Therefore, an improvement was achieved by reducing the overall score.
Measured: baseline (OLE visit 0 and parent study visit 1 [week 1]), visits 3 (week 11) and 5 (week 23)
Change in the 100-mm VAS Pain Score Visual Analogue Scale (100 mm VAS)
Mean change in the VAS pain score from baseline (visit 0 [screening] of the OLE and visit 1 [week 1] of the parent study to visit 2 (week 1), visit 3 (week 11) and visit 5 (week 23). The 0 to 100 mm visual analogue scale (VAS) was used for measuring pain intensity. VAS ratings between 0 and 4 mm were interpreted as no pain, 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain. The pain VAS was self-completed by the patients.
Measured: baseline (OLE visit 0 and study 1 visit 1 [week 1]), OLE visits 3 (week 11) and 5 (week 23)
Patient's Assessment of the Treatment Efficacy
Patient satisfaction with treatment was measured by a 6-point Likert scale (evident aggravation, aggravation, without changes, weak improvement, improvement, significant improvement) at the study visits 3 (week 11) and 5 (week 23).
Measured: visits 3 (week 13) and 5 (week 25)
Investigator's Assessment of the Treatment Efficacy
Investigator satisfaction with treatment was measured by a 6-point Likert scale (evident aggravation, aggravation, without changes, weak improvement, improvement, significant improvement) at the study visits 3 (week 11) and 5 (week 23).
Measured: visits 3 (week 13) and 5 (week 25)
Total Number of Paracetamol Tablets Taken
A patient diary was used to capture data about the number of paracetamol 500 mg tablets taken.
Measured: visits 3 (week 13) and 5 (week 25)
Total Number of NSAID Tablets Taken
A patient diary was used to capture data about the number of NSAID tablets taken. In case of paracetamol ineffectiveness and pain persistence patient was allowed to take protocol-permitted NSAID at certain doses.
Measured: visits 3 (week 11) and 5 (week 23)
The JSN in the Target Knee
Joint space narrowing (JSN) was scored by comparison of subsequent radiographs taken over time. An increase in the radiographic knee JSN is associated with osteoarthritis progression.
Measured: baseline (visit 1 of the parent study IA/PAAG-SI/OA/2019), visit 5 (week 23) of OLE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start28 May 2020
- Primary completion28 Dec 2020
- Study completion12 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This was an open-label extension (OLE) of the IA/PAAG-SI/OA/2019 study designed to evaluate the long-term safety and efficacy of MD NOLTREX™ in patients with knee osteoarthritis (OA). The study was expected to enroll 72 patients who had completed the parent study. Actually 67 patients rolled over into the OLE, 2 of them were classified as screen failures and 65 were enrolled into the trial.
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Centre BIOFORM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vladimir V Popov, DSc, Principal investigator, Non-budgetary HCF "Railway clinical hospital n.a. Semashko N.A. at Lublino, OJSC "Russian Railways"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429319
- Sponsor's protocol ID
- IA/PAAG-SI/OA/2020
- Status last verified
- Nov 2024
- First submitted
- 14 Aug 2020
- Last updated
- 6 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Multicenter Postmarketing Extension Study of Efficacy and Safety of Intra-articular HBISA Endoprosthesis of Synovial Fluid NOLTREX™ in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06429319
- Acronym / sponsor ID
- IA/PAAG-SI/OA/2020
- Conditions
- Osteoarthritis
- Keywords
- intra-articular, polyacrylamide hydrogel, PAAG, HBISA (Hydrous biopolymer with silver ions "Argiform"), NOLTREX
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Research Centre BIOFORMIndustry (pharma, biotech, devices)
- Study start
- 28 May 2020 (actual)
- Primary completion
- 28 Dec 2020 (actual)
- Study completion
- 12 May 2021 (actual)
- First posted
- 24 May 2024 (actual)
- Results
- Posted 6 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The OLE was aimed to assess long-term safety and efficacy of one and two courses of IA HBISA in patients with knee osteoarthritis.
Detailed description
HBISA (polyacrylamide hydrogel) endoprosthesis of synovial fluid NOLTREX™ is intended for the symptomatic treatment of adult patients with osteoarthritis (OA) reducing pain and improving mobility.
The aim of the 6-month OLE was to evaluate the long-term safety and efficacy of one and two courses of IA Polyacrylamide hydrogel with silver ions in patients with knee osteoarthritis who had received at least one IA injection of NOLTREX™ and completed the visit 5 in the IA/PAAG-SI/OA/2019 study.
In OLE patients who had received a course of treatment (one or two weekly intra-articular injections of 4.0 NOLTREX™ depending on the stage of OA and the clinical response to treatment) in the parent study might receive a single repeat course of NOLTREX™ at the visits 1/2 or 3/4 when clinically indicated. The WOMAC was the primary outcome measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This was an open-label extension (OLE) of the IA/PAAG-SI/OA/2019 study designed to evaluate the long-term safety and efficacy of MD NOLTREX™ in patients with knee osteoarthritis (OA). The study was expected to enroll 72 patients who had completed the parent study. Actually 67 patients rolled over into the OLE, 2 of them were classified as screen failures and 65 were enrolled into the trial.
| Arm | Type | Receives |
|---|---|---|
| Medical Device: HBISA (polyacrylamide hydrogel) synovial fluid endoprosthesis NOLTREX™ | Other | Device: Hydrous biopolymer with silver ions "Argiform" (HBISA) endoprosthesis of synovial fluid NOLTREX™Sixty-five (65) patients were included in the study and divided into three groups based on the number of NOLTREX™ courses received: * Group A consisted of 5 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 1/2 of OLE (IA/PAAG-SI/OA/2020) study. * Group B comprised 43 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 3/4 of OLE. * Group C consisted of 17 patients who had received only 1 NOLTREX™ course in the parent study. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women over 50 years of age;
- Provision of signed informed consent form;
- Patients met ACR classification criteria for knee osteoarthritis (pain in the knee and at least three of the following: age >50 years, stiffness <30 min, crepitus, bony tenderness, bony enlargement and no palpable warmth);
- OA grades 2 and 3 on the Kellgren-Lawrence scale with the predominant involvement of the medial tibiofemoral region of the knee joint;
- Patients from the NOLTREX™ group of the parent study (IA/PAAG-SI/OA/2019) who completed all (5) study visits
Key exclusion criteria (24 listed)
- Pregnancy and breastfeeding;
- History of trauma or surgery on the target knee joint;
- Instability of the target knee joint;
- Microcrystalline arthropathies (according to the history and taking into account clinical manifestations);
- History of systemic inflammatory diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrous biopolymer with silver ions "Argiform" (HBISA) endoprosthesis of synovial fluid NOLTREX™Also: Polyacrylamide hydrogel with silver ionsIf 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). | Device | Medical Device: HBISA (polyacrylamide hydrogel) synovial fluid endoprosthesis NOLTREX™ |
Primary outcome
Change in the Total WOMAC Score (WOMAC-T)
Time frame: baseline (OLE visit 0 and visit 1 study 1 [week 1]), OLE visits 3 (week 11) and 5 (week 23)
Mean change in WOMAC-T from baseline (visit 0 [screening] of OLE and visit 1 (week 1) of the parent study) to visit 3 (week 11) and visit 5 (week 23). Patients were asked to complete the questionnaire during the study visits. The Western Ontario and McMaster Universities Osteoarthritis Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100-mm VAS and consists of three subscales: pain (5 questions), stiffness (2 questions), and physical function (17 questions). The scores for each subscale are summed up, with a possible score range of 0-500 for Pain, 0-200 for Stiffness, and 0-1700 for Physical Function. Higher scores represent worse pain, stiffness, and functional limitations. A sum of the scores for all three subscales gives a total WOMAC score (0-2400), where 0 represents the best and 2400 the worst possible health status. The higher the score, the poorer the function. Therefore, an improvement was achieved by reducing the overall score.
9 secondary outcomes
Change in the WOMAC Pain Score (WOMAC-A)
Time frame: baseline (OLE visit 0 and visit 1 study 1 [week 1]), OLE visits 3 (week 11) and 5 (week 23)
Change in the WOMAC Stiffness (WOMAC-B) Score
Time frame: baseline (OLE visit 0 and parent study visit 1 [week 1]), visits 3 (week 11) and 5 (week 23)
Change in the WOMAC Physical Function (WOMAC-C) Score
Time frame: baseline (OLE visit 0 and parent study visit 1 [week 1]), visits 3 (week 11) and 5 (week 23)
Change in the 100-mm VAS Pain Score Visual Analogue Scale (100 mm VAS)
Time frame: baseline (OLE visit 0 and study 1 visit 1 [week 1]), OLE visits 3 (week 11) and 5 (week 23)
Patient's Assessment of the Treatment Efficacy
Time frame: visits 3 (week 13) and 5 (week 25)
Investigator's Assessment of the Treatment Efficacy
Time frame: visits 3 (week 13) and 5 (week 25)
Total Number of Paracetamol Tablets Taken
Time frame: visits 3 (week 13) and 5 (week 25)
Total Number of NSAID Tablets Taken
Time frame: visits 3 (week 11) and 5 (week 23)
The JSN in the Target Knee
Time frame: baseline (visit 1 of the parent study IA/PAAG-SI/OA/2019), visit 5 (week 23) of OLE
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir V Popov, DSc principal investigator
Non-budgetary HCF "Railway clinical hospital n.a. Semashko N.A. at Lublino, OJSC "Russian Railways"
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrous biopolymer with silver ions "Argiform" (HBISA) endoprosthesis of synovial fluid NOLTREX™ in people with Osteoarthritis, run by Research Centre BIOFORM at 4 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Total WOMAC Score (WOMAC-T) (time frame: baseline (OLE visit 0 and visit 1 study 1 [week 1]), OLE visits 3 (week 11) and 5 (week 23)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.