Degenerative OsteoarthritisPhase 2/3NCT02687399
Determine the Efficacy of TT-173. Reducing the the Total Blood Loss Associated With Total Knee Arthroplasty (HESTAT)
A Phase 2/3 study testing TT-173 in people with Degenerative Osteoarthritis, run by Thrombotargets Europe S.L at 1 site in Spain.
Trial summary
The purpose of this study is to determine the haemostatic efficacy of TT-173, reducing the total blood loss associated with the total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Osteoarthritis
- What is being tested?
- TT-173
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2016to Dec 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who signed the informed consent.
- Patients affected of degenerative osteoarthritis of the knee that have to undergo a primary total knee replacement.
- Patients of both sexes older than 18 years.
- Female patients in childbearing age* that are not permanently sterile, should present a negative pregnancy test and should agree to use a medically accepted anti contraceptive method during its participation in the study. This includes oral, intravaginal, transdermal, injectable or implantable hormonal contraceptives, sexual abstinence, bilateral tubal occlusion, intrauterine hormone-releasing system or dispositive and vasectomy of the partner.
- Includes the period between menarche and until becoming post-menopausal. A woman is considered post-menopausal when she has gone without a period for 12 consecutive months.
- Patients must have a haemoglobin concentration ≥ to 12.5 g/dL at the selection visit.
Who cannot join
- Patients affected of any kind of congenital or acquired coagulopathies or with personal history of abnormal haemorrhagic episodes.
- Patients subjected to knee replacement due to rheumatoid or seronegative arthritis, infection or other autoimmune inflammatory causes of join degeneration.
- Patients subjected to revision procedures of the knee, hemiarthroplasty or that will receive non-cemented knee prosthesis.
- Subjects affected of a serious medical condition that would compromise their clinical outcome such as hepatic, respiratory, cardiac or renal insufficiency, acute infectious disease and active cancer.
- Subjects with known history of haematological alterations which are causative of thrombophilia.
- Subjects with personal history of deep vein thrombosis, pulmonary thromboembolism, retinal vascular occlusion or multiple abortions.
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- Subjects with known hypersensitivity or allergy to any component of the drug.
- Subjects that are currently under treatment with anticoagulant, antiplatelet or antifibrinolytic drugs. These subjects may be eligible if the treatment is stopped preoperatively according with the conditions indicated in section 9.2.
- Subjects who have received treatment (erythropoietin, iron, folate) to improve preoperative anaemia.
- Subjects who are not free to give informed consent or who are mentally incapacitated to the discretion of investigators.
- Subjects who participate or have participated in the past three months in another clinical trial with drug treatment.
- Subjects that are the investigators, collaborators, nurses, centre employees or any other person directly related to the development of the protocol.
- Subjects who are pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Thrombotargets Europe SL
Castelldefels, Barcelona, 08860
Ramon Lopez, +34 93 6642040, ramonlopez@thrombotargets.com
About this study
Official title: A Phase II/III, Randomized, Controlled, Single Blind Study to Evaluate the Haemostatic Efficacy and Safety of Topically Applied TT-173 in Patients Undergoing Knee Arthroplasty
The purpose of this study is to determine the haemostatic efficacy of TT-173, reducing the total blood loss associated with the total knee arthroplasty.
Read the detailed description
As the TT-173 has been cleared for use as a topical hemostatic agent, the proposed study will further investigate the safety and efficacy of TT-173 in the knee arthroplasty.
- Conditions
- Degenerative Osteoarthritis
- Being tested
- placebo, TT-173
- Keywords
- knee arthroplasty
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
After prosthesis cementation and just before knee suture and tourniquet liberation, the patients randomized in the placebo group will receive placebo for inyection sprayed on the exposed tissues of the knee.
TT-173Biological
After prosthesis cementation and just before knee suture and tourniquet liberation, the patients randomized in the treatment group will receive TT-173 for inyection sprayed on the exposed tissues of the knee.
| Study group | Role | What they receive |
|---|---|---|
| TT-173 | Experimental | It will be sprayed using this syringe and a nozzle tip couplet to it one time over the surgical lesion surfaces on the exposed tissues of the knee Receives: Biological: TT-173 |
| placebo | Placebo comparator | It will be sprayed over the surgical lesion surfaces on the exposed tissues of the knee Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
total blood loss
Measured: 2 day
Secondary outcomes (7)
Maximum decrease in venous haemoglobin concentration
Measured: 2 day
Blood collected in the drainage
Measured: 1 day
Transfusion rate
Measured: 35 days
Number of units of blood concentrates transfused
Measured: 35 days
Range of knee motion (Knee flexion and extension)
Measured: 35 days
Systemic absorption (detectable increase of TF blood concentration at any time of the pharmacokinetics sampling)
Measured: 15 days
Immunogenicity (detectable increase of reactive antibodies against the product )
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Degenerative 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thrombotargets Europe S.L
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Santiago Rojas, Study director, Thrombotargets Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687399
- Sponsor's protocol ID
- THO-IM_02-CT
- Other IDs
- 2015-003408-21, 2015
- Status last verified
- Feb 2018
- First submitted
- 9 Feb 2016
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Lopez-Lopez J, Jane-Salas E, Santamaria A, Gonzalez-Navarro B, Arranz-Obispo C, Lopez R, Miquel I, Arias B, Sanchez P, Rincon E, Rodriguez JR, Rojas S, Murat J. TETIS study: evaluation of new topical hemostatic agent TT-173 in tooth extraction. Clin Oral Investig. 2016 Jun;20(5):1055-63. doi: 10.1007/s00784-015-1586-1. Epub 2015 Sep 15.
PubMed 26374745Gonzalez-Osuna A, Videla S, Canovas E, Urrutia G, Rojas S, Lopez R, Murat J, Aguilera X. HESTAT: Study protocol for a phase II/III, randomized, placebo-controlled, single blind study to evaluate the new hemostatic agent TT-173 in total knee arthroplasty. Contemp Clin Trials. 2017 Oct;61:16-22. doi: 10.1016/j.cct.2017.07.004. Epub 2017 Jul 4.
PubMed 28687347
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III, Randomized, Controlled, Single Blind Study to Evaluate the Haemostatic Efficacy and Safety of Topically Applied TT-173 in Patients Undergoing Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02687399
- Acronym / sponsor ID
- THO-IM_02-CT
- Conditions
- Degenerative Osteoarthritis
- Keywords
- knee arthroplasty
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Thrombotargets Europe S.LIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 22 Feb 2016 (estimated)
- 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 purpose of this study is to determine the haemostatic efficacy of TT-173, reducing the total blood loss associated with the total knee arthroplasty.
Detailed description
As the TT-173 has been cleared for use as a topical hemostatic agent, the proposed study will further investigate the safety and efficacy of TT-173 in the knee arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TT-173 | Experimental | Biological: TT-173It will be sprayed using this syringe and a nozzle tip couplet to it one time over the surgical lesion surfaces on the exposed tissues of the knee |
| placebo | Placebo comparator | Other: placeboIt will be sprayed over the surgical lesion surfaces on the exposed tissues of the knee |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who signed the informed consent.
- Patients affected of degenerative osteoarthritis of the knee that have to undergo a primary total knee replacement.
- Patients of both sexes older than 18 years.
- Female patients in childbearing age* that are not permanently sterile, should present a negative pregnancy test and should agree to use a medically accepted anti contraceptive method during its participation in the study. This includes oral, intravaginal, transdermal, injectable or implantable hormonal contraceptives, sexual abstinence, bilateral tubal occlusion, intrauterine hormone-releasing system or dispositive and vasectomy of the partner.
- Patients must have a haemoglobin concentration ≥ to 12.5 g/dL at the selection visit.
Key exclusion criteria (13 listed)
- Patients affected of any kind of congenital or acquired coagulopathies or with personal history of abnormal haemorrhagic episodes.
- Patients subjected to knee replacement due to rheumatoid or seronegative arthritis, infection or other autoimmune inflammatory causes of join degeneration.
- Patients subjected to revision procedures of the knee, hemiarthroplasty or that will receive non-cemented knee prosthesis.
- Subjects affected of a serious medical condition that would compromise their clinical outcome such as hepatic, respiratory, cardiac or renal insufficiency, acute infectious disease and active cancer.
- Subjects with known history of haematological alterations which are causative of thrombophilia.
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 |
|---|---|---|
| placeboAfter prosthesis cementation and just before knee suture and tourniquet liberation, the patients randomized in the placebo group will receive placebo for inyection sprayed on the exposed tissues of the knee. | Other | placebo |
| TT-173After prosthesis cementation and just before knee suture and tourniquet liberation, the patients randomized in the treatment group will receive TT-173 for inyection sprayed on the exposed tissues of the knee. | Biological | TT-173 |
Primary outcome
total blood loss
Time frame: 2 day
7 secondary outcomes
Maximum decrease in venous haemoglobin concentration
Time frame: 2 day
Blood collected in the drainage
Time frame: 1 day
Transfusion rate
Time frame: 35 days
Number of units of blood concentrates transfused
Time frame: 35 days
Range of knee motion (Knee flexion and extension)
Time frame: 35 days
Systemic absorption (detectable increase of TF blood concentration at any time of the pharmacokinetics sampling)
Time frame: 15 days
Immunogenicity (detectable increase of reactive antibodies against the product )
Time frame: 35 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Background: PubMed 26374745Lopez-Lopez J, Jane-Salas E, Santamaria A, Gonzalez-Navarro B, Arranz-Obispo C, Lopez R, Miquel I, Arias B, Sanchez P, Rincon E, Rodriguez JR, Rojas S, Murat J. TETIS study: evaluation of new topical hemostatic agent TT-173 in tooth extraction. Clin Oral Investig. 2016 Jun;20(5):1055-63. doi: 10.1007/s00784-015-1586-1. Epub 2015 Sep 15.
- Derived from this study: PubMed 28687347Gonzalez-Osuna A, Videla S, Canovas E, Urrutia G, Rojas S, Lopez R, Murat J, Aguilera X. HESTAT: Study protocol for a phase II/III, randomized, placebo-controlled, single blind study to evaluate the new hemostatic agent TT-173 in total knee arthroplasty. Contemp Clin Trials. 2017 Oct;61:16-22. doi: 10.1016/j.cct.2017.07.004. Epub 2017 Jul 4.
- For more information about this study; Clinical Oral Investigations journalLink provided by the sponsor.
- 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.
Santiago Rojas study director
Thrombotargets Europe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TT-173 in people with Degenerative Osteoarthritis, run by Thrombotargets Europe S.L at 1 site in Spain.
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 6 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Santiago Rojas, Manager (+34936642040, santiagorojasz@thrombotargets.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total blood loss (time frame: 2 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02687399, which also lists 2 linked publications.
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 22 Feb 2018.