Thrombotic DisordersPhase 2NCT03393481
Prevention of Thromboembolic Events in Total Knee Replacement Patients
A Phase 2 study testing MAA868 and Enoxaparin in people with Thrombotic Disorders, run by Novartis Pharmaceuticals.
Trial summary
The purpose of the study is to find out whether MAA868, is able to prevent blood clots following your medical condition (surgery for knee replacement) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thrombotic Disorders
- What is being tested?
- MAA868 and Enoxaparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 3 Oct 2018to 17 Apr 2020
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo elective unilateral total knee arthroplayts (TKA)
- Willing to comply with study requirements including bilateral venography at Day 12 ± 2 days
- Body weight between 50 kg and 130 kg inclusive.
- Normal aPTT, PT, INR at screening
Who cannot join
- History of arterial or venous thromboembolism; abnormally extended primary or secondary bleeding after trauma or intervention, stroke, transient ischemic attack or traumatic or non-traumatic intracranial bleed; bleeding disorder; MI or unstable angina pectoris within 12 months of the screening; Uncontrolled hypertension (SBP/DBP ≥ 150/95 mmHg at the screening).
- Medications that increase the risk of bleeding, including antiplatelet (such as aspirin), anticoagulant and fibrinolytic agents; eGFR < 60 mL/min/1.73m2; Poorly controlled diabetes (HbA1C >10%); Liver dysfunction (ALT/AST >3 xULN or TBL >2 x ULN); BMI ≥ 40 kg/m2
About this study
Official title: A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Active-controlled Phase 2 Study to Compare the Efficacy and Safety of s.c. MAA868 Versus s.c. Enoxaparin in Adult Patients Undergoing Unilateral Total Knee Arthroplasty
The purpose of the study is to find out whether MAA868, is able to prevent blood clots following your medical condition (surgery for knee replacement)
- Conditions
- Thrombotic Disorders
- Being tested
- MAA868, Enoxaparin
- Keywords
- biologic,, venous thromboembolism,, unilateral knee arthroplasty
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAA868Drug
MAA868 dose 1 and dose 2, single administration, subcutaneous,
EnoxaparinDrug
Enoxaparin 40 mg, o.d X 10 days
| Study group | Role | What they receive |
|---|---|---|
| MAA868 dose 1 | Experimental | MAA868 dose 1, single administration, subcutaneous Receives: Drug: MAA868 |
| MAA868 dose 2 | Experimental | MAA868 dose 2, single administration, subcutaneous Receives: Drug: MAA868 |
| Enoxaparin | Active comparator | Enoxaparin 40mg, once daily (o.d.) for 10 days Receives: Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with confirmed composite endpoint
Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death
Measured: Day 14
Secondary outcomes (2)
Number of patients with composite bleeding
Occurrence of confirmed composite endpoint of major bleeding and clinically relevant non-major (CRNM) bleeding events
Measured: Day 1 to Day 50
Number of patients with composite venous thromboembolic events (VTE)
Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), Confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death
Measured: Day 1 to Day 110
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start3 Oct 2018 (estimated)
- Primary completion8 Jan 2020 (estimated)
- Study completion17 Apr 2020 (estimated)
Why it stopped: Trial cancelled before First Patient First Visit (no patient enrolled)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombotic DisordersStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393481
- Sponsor's protocol ID
- CMAA868A2201
- Other IDs
- 2017-002925-39, 2017
- Status last verified
- Oct 2020
- First submitted
- 3 Jan 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Active-controlled Phase 2 Study to Compare the Efficacy and Safety of s.c. MAA868 Versus s.c. Enoxaparin in Adult Patients Undergoing Unilateral Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03393481
- Acronym / sponsor ID
- CMAA868A2201
- Conditions
- Thrombotic Disorders
- Keywords
- biologic,, venous thromboembolism,, unilateral knee arthroplasty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Trial cancelled before First Patient First Visit (no patient enrolled)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2018 (estimated)
- Primary completion
- 8 Jan 2020 (estimated)
- Study completion
- 17 Apr 2020 (estimated)
- First posted
- 8 Jan 2018 (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 purpose of the study is to find out whether MAA868, is able to prevent blood clots following your medical condition (surgery for knee replacement)
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MAA868 dose 1 | Experimental | Drug: MAA868MAA868 dose 1, single administration, subcutaneous |
| MAA868 dose 2 | Experimental | Drug: MAA868MAA868 dose 2, single administration, subcutaneous |
| Enoxaparin | Active comparator | Drug: EnoxaparinEnoxaparin 40mg, once daily (o.d.) for 10 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled to undergo elective unilateral total knee arthroplayts (TKA)
- Willing to comply with study requirements including bilateral venography at Day 12 ± 2 days
- Body weight between 50 kg and 130 kg inclusive.
- Normal aPTT, PT, INR at screening
Key exclusion criteria (2 listed)
- History of arterial or venous thromboembolism; abnormally extended primary or secondary bleeding after trauma or intervention, stroke, transient ischemic attack or traumatic or non-traumatic intracranial bleed; bleeding disorder; MI or unstable angina pectoris within 12 months of the screening; Uncontrolled hypertension (SBP/DBP ≥ 150/95 mmHg at the screening).
- Medications that increase the risk of bleeding, including antiplatelet (such as aspirin), anticoagulant and fibrinolytic agents; eGFR < 60 mL/min/1.73m2; Poorly controlled diabetes (HbA1C >10%); Liver dysfunction (ALT/AST >3 xULN or TBL >2 x ULN); BMI ≥ 40 kg/m2
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 |
|---|---|---|
| MAA868MAA868 dose 1 and dose 2, single administration, subcutaneous, | Drug | MAA868 dose 1, MAA868 dose 2 |
| EnoxaparinEnoxaparin 40 mg, o.d X 10 days | Drug | Enoxaparin |
Primary outcome
Number of patients with confirmed composite endpoint
Time frame: Day 14
Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death
2 secondary outcomes
Number of patients with composite bleeding
Time frame: Day 1 to Day 50
Number of patients with composite venous thromboembolic events (VTE)
Time frame: Day 1 to Day 110
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: Undecided. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MAA868 and Enoxaparin in people with Thrombotic Disorders, run by Novartis Pharmaceuticals.
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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of patients with confirmed composite endpoint (time frame: Day 14). 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 8 Oct 2020.