Osteo Arthritis of the KneeHALONCT07516457
Hydrogel Assessment for Local Treatment of Osteoarthritis
A study testing Injection of Hydrogel OA 2% in people with Osteo Arthritis of the Knee, run by Allegro NV/SA at 3 sites in Belgium.
Trial summary
The study aims to evaluate the safety and tolerability of one intra-articular injection of Hydrogel OA 2% for the symptomatic treatment of osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Osteo Arthritis of the Knee
- What is being tested?
- Injection of Hydrogel OA 2%
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesBelgium
- Study dates
- 17 Apr 2026to 15 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults accepting to participate in the study and having signed the written informed consent form before any protocol-specific procedures and able to understand and follow the instructions as described in the protocol.
- Unilateral symptomatic tibiofemoral KOA confirmed by a "stand-ing knee" X-ray. In case of bilateral KOA on X-ray only one knee (index knee) presents symptomatic OA pain.
- Age 35 ≤ 75 years.
- BMI 20 ≤ 35.
- Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain score 25 ≤ 70.
- Patients impacted by pain in the index knee during daily activi-ties.
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- Radiological Kellgren and Lawrence (K\&L) grade II and III of the index knee from a standing knee radiograph assessed during the screening visit, using the most recent X-ray taken either im-mediately or within the past 3 months.
- Fully ambulatory for functional assessments.
- Willingness to refrain from taking any pain medication for 48 hours prior to investigational device injection on day 0.
- Female subjects must be on effective contraception (pill, patch, ring, diaphragm, implant or intrauterine device) and must perform a pregnancy test, of which the result must be negative, at the treatment visit unless they are surgically sterile (tubal ligation or hysterectomy) or postmenopausal for at least one year.
Who cannot join
- Bilateral tibiofemoral KOA where the non-index knee presents a worse radiological grade of KOA than the index knee.
- Significant clinically assessed varus or valgus deformation of the selected knee side of more than 10 degrees.
- Extension deficit of the index knee higher than 5 degrees.
- Bilateral symptomatic tibiofemoral KOA or combined ipsilateral symptomatic tibiofemoral knee and hip OA.
- Clinical signs of significant effusion with noticeable swelling and/or inflammation related to severe pain.
- Active lymphatic or venous stasis or serious blood disorders (e.g., anemia), bleeding disorders (e.g., hemophilia), blood clots, or blood cancers (e.g., leukemia, lymphoma, and myeloma).
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- Active bacterial infection, resulting in hospitalization and/or requiring intravenous antibiotic treatment.
- Synovial infection, skin infection or skin diseases in the area of the injection site.
- History of autoimmune diseases that causes chronic joint pain and inflammation in the knee joint, including rheumatoid arthritis, psoriasis arthritis, juvenile idiopathic arthritis, systemic lupus erythematosus, gout, pseudogout, systemic sclerosis, Sjögren's disease, adult-onset still's disease.
- Known or suspected generalized chronic pain disorder.
- Severe alteration of mobility preventing any functional assessment.
- Allergy or hypersensitivity to any of the product components of Hydrogel OA 2%.
- Conditions (orthopedic, rheumatologic, musculoskeletal or inflammatory) causing symptomatic and/or radiating pain in the lower extremities that might interfere with the symptomatic OA knee pain, including hip OA assessed by physical examination by the physician.
- Symptomatic patellofemoral knee OA.
- Oral corticotherapy in the last 3 months before injection of the investigational device.
- Regular/chronic use of opioid drugs in the last 3 months before injection. Use of any opioid drug during the last 7 days prior to injection of the investigational device.
- Severe acute illness within 14 days prior to injection of the investigational device.
- Pain Catastrophizing Scale score of 30 or higher.
- Any intra-articular injection (hyaluronan, hydrogel, soft implant, corticosteroid, platelet-rich plasma, local anesthetic etc.) arthroscopy, surgery in the index knee; or cell-based therapy or an invasive procedure on the index knee in the last 6 months before injection of the investigational device.
- Anticipated need for any surgical or other invasive procedure in the index knee throughout the course of the clinical investigation, including prosthesis and/or any concurrent OA treatments including alternative treatments.
- Any investigator-assessed clinically significant condition that may represent a substantial risk to the patient or may have an impact on the study assessments.
- Participation in another clinical trial in the last 3 months before injection of the investigational device.
- Pregnancy and breastfeeding.
- Legal incapacity or limited legal capacity to consent.
- Trauma of the index knee in the last 6 months before injection of the investigational device.
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: A Prospective, Multi-Center, Open-Label Study to Evaluate the Safety and Tolerability of Hydrogel OA 2% in Patients With Knee Osteoarthritis
The study aims to evaluate the safety and tolerability of one intra-articular injection of Hydrogel OA 2% for the symptomatic treatment of osteoarthritis of the knee.
Read the detailed description
The primary objective of this investigation is to assess the safety and tolerability of Hydrogel OA 2% in subjects with symptomatic KOA up to 13 weeks after injection of the device.
The secondary objective of this investigation is to assess the safety and tolerability of Hydrogel OA 2% in subjects with symptomatic KOA up to 12 months after injection of the device.
The exploratory objective of this investigation is to assess the clinical efficacy of Hydrogel OA 2% in subjects with symptomatic KOA.
- Conditions
- Osteo Arthritis of the Knee
- Being tested
- Injection of Hydrogel OA 2%
- Keywords
- osteoarthritis, knee
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of Hydrogel OA 2%Device
Single injection
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Single Injection of Investigational Device Receives: Device: Injection of Hydrogel OA 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Device- or Procedure-Related Serious Adverse Events
Occurrence of any device or procedure related (serious) adverse event up to 13 weeks after injection of the investigational device.
Measured: 13 weeks
Secondary outcomes (1)
Occurrence of Device- or Procedure-Related Serious Adverse Events
Occurrence of any device or procedure related (serious) adverse event up to 12 months after injection of the investigational device.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start17 Apr 2026
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis of the KneeStudies 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allegro NV/SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516457
- Sponsor's protocol ID
- DHF-001-DVaP-002-01
- Acronym
- HALO
- Status last verified
- Jul 2026
- First submitted
- 1 Apr 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Open-Label Study to Evaluate the Safety and Tolerability of Hydrogel OA 2% in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07516457
- Acronym / sponsor ID
- HALO / DHF-001-DVaP-002-01
- Conditions
- Osteo Arthritis of the Knee
- Keywords
- osteoarthritis, knee
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Allegro NV/SAIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to evaluate the safety and tolerability of one intra-articular injection of Hydrogel OA 2% for the symptomatic treatment of osteoarthritis of the knee.
Detailed description
The primary objective of this investigation is to assess the safety and tolerability of Hydrogel OA 2% in subjects with symptomatic KOA up to 13 weeks after injection of the device.
The secondary objective of this investigation is to assess the safety and tolerability of Hydrogel OA 2% in subjects with symptomatic KOA up to 12 months after injection of the device.
The exploratory objective of this investigation is to assess the clinical efficacy of Hydrogel OA 2% in subjects with symptomatic KOA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Device: Injection of Hydrogel OA 2%Single Injection of Investigational Device |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adults accepting to participate in the study and having signed the written informed consent form before any protocol-specific procedures and able to understand and follow the instructions as described in the protocol.
- Unilateral symptomatic tibiofemoral KOA confirmed by a "stand-ing knee" X-ray. In case of bilateral KOA on X-ray only one knee (index knee) presents symptomatic OA pain.
- Age 35 ≤ 75 years.
- BMI 20 ≤ 35.
- Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain score 25 ≤ 70.
Key exclusion criteria (25 listed)
- Bilateral tibiofemoral KOA where the non-index knee presents a worse radiological grade of KOA than the index knee.
- Significant clinically assessed varus or valgus deformation of the selected knee side of more than 10 degrees.
- Extension deficit of the index knee higher than 5 degrees.
- Bilateral symptomatic tibiofemoral KOA or combined ipsilateral symptomatic tibiofemoral knee and hip OA.
- Clinical signs of significant effusion with noticeable swelling and/or inflammation related to severe pain.
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 |
|---|---|---|
| Injection of Hydrogel OA 2%Single injection | Device | Interventional |
Primary outcome
Occurrence of Device- or Procedure-Related Serious Adverse Events
Time frame: 13 weeks
Occurrence of any device or procedure related (serious) adverse event up to 13 weeks after injection of the investigational device.
1 secondary outcome
Occurrence of Device- or Procedure-Related Serious Adverse Events
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of Hydrogel OA 2% in people with Osteo Arthritis of the Knee, run by Allegro NV/SA at 3 sites in Belgium.
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 10 inclusion and 25 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: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. 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?
This study is still under way. Results are not available in the source record yet.
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?
Occurrence of Device- or Procedure-Related Serious Adverse Events (time frame: 13 weeks). 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 14 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.