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AzTrials

Venous Thromboembolism (VTE)Phase 2NCT07850453

Vortosiran for VTE Prevention

A Phase 2 study testing Vortosiran in people with Venous Thromboembolism (VTE) and Cancer, run by Ribocure Pharmaceuticals AB at 30 sites in 4 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Blood clots remain a serious cause of illness and death. Long-term treatment and prevention of these clots with blood thinners is often limited by bleeding risk, drug interactions, and daily dosing, leading many patients to stop treatment early. Both cancer and chemotherapy further increase the risk of clot formation. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Vortosiran
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
30 sitesin 4 countries
Study dates
Oct 2026to May 2028
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cohort A
  • Adult male and female participants (≥18 years) meeting the specified below criteria for Cohort A.
  • Postmenopausal women are eligible without additional contraceptive measures.
  • Postmenopausal status is defined as:
  • Age ≥55 years with ≥12 months of spontaneous amenorrhoea, or
  • Age <55 years with ≥12 months of spontaneous amenorrhoea and follicle-stimulating hormone in the postmenopausal range, or surgical menopause (bilateral oophorectomy, with or without hysterectomy) documented in the medical history.
Show all 23Show fewer
  • Women of childbearing potential must agree to use highly effective contraception for the duration of trial treatment and for the specified post-treatment period.
  • Able and willing to provide written informed consent and to comply with trial procedures and follow-up.
  • Objectively confirmed symptomatic index of the lower limbs at the popliteal vein or more proximal, and/or symptomatic PE, documented by objective imaging modalities (eg. DVT: compression ultrasonography/duplex ultrasound; computed tomography/magnetic resonance venography; or contrast venography. PE: computed tomography pulmonary angiography; high probability ventilation/perfusion scan; or pulmonary angiography).
  • Completed 3 to 12 months of standard therapeutic anticoagulant therapy for the index VTE episode (vitamin K antagonists, DOACs, low molecular weight heparin, or fondaparinux at therapeutic dose) at least 2 weeks before randomization.
  • Cohort B
  • Adult male and female participants (≥18 years) meeting the specified below criteria for Cohort B.
  • Postmenopausal women are eligible without additional contraceptive measures.
  • Postmenopausal status is defined as:
  • Age ≥55 years with ≥12 months of spontaneous amenorrhoea, or
  • Age <55 years with ≥12 months of spontaneous amenorrhoea and follicle-stimulating hormone in the postmenopausal range, or surgical menopause (bilateral oophorectomy, with or without hysterectomy) documented in the medical history.
  • Women of childbearing potential must agree to use highly effective contraception for the duration of trial treatment and for the specified post-treatment period.
  • Able and willing to provide written informed consent and to comply with trial procedures and follow-up.
  • Eastern Cooperative Oncology Group performance status 0-2 during screening
  • Newly diagnosed cancer site or progression of malignant disease, with:
  • No recent chemotherapy or radiotherapy (≤3 months), and
  • No recent surgery (≤2 weeks).
  • Histologically or cytologically confirmed active malignancy (solid tumor or lymphoma) requiring initiation of a new systemic cytotoxic chemotherapy course; newly diagnosed disease or documented progression/recurrence qualifies.

Who cannot join

  • Cohort A
  • Women who are pregnant, currently breastfeeding, or planning pregnancy during the trial or within the defined post-treatment period are not eligible.
  • Evidence of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection at Screening, defined as any of the following:
  • Positive hepatitis B surface antigen (HBsAg), or positive total hepatitis B core antibody (anti-HBc) with detectable HBV DNA;
  • Positive hepatitis C virus antibody (anti-HCV) with detectable HCV RNA; or
  • Reactive HIV-1/2 antigen/antibody test confirmed by a positive confirmatory test.
Show all 44Show fewer
  • Participants who are total anti-HBc-positive must undergo HBV DNA testing, and participants who are anti-HCV-positive must undergo HCV RNA testing. Participants with undetectable HBV DNA or HCV RNA may be eligible provided there is no clinical or laboratory evidence of active liver disease.
  • Planned surgery that may change VTE/bleeding risk during the trial period and no recent surgery (≤2 weeks prior screening).
  • Any serious medical, psychiatric, or social condition that, in the investigator's opinion, would interfere with trial participation, compliance, or interpretation of trial results.
  • eGFR <30 mL/min (calculated per CKD-EPI 2021, expected to be reported in mL/min per 1.73 m2)
  • Clear indication for indefinite/extended anticoagulation for any reason, including but not limited to:
  • Atrial fibrillation or flutter requiring anticoagulation.
  • Mechanical heart valve or moderate/severe rheumatic mitral stenosis.
  • Recent or ongoing VTE requiring therapeutic anticoagulation (symptomatic or incidental).
  • Known antiphospholipid syndrome with a high-risk profile, defined as the presence of lupus anticoagulant.
  • Active cancer requiring anticoagulant prophylaxis or treatment.
  • Strong thrombophilia (eg, homozygous factor V Leiden, homozygous prothrombin mutation, combined thrombophilias, antithrombin deficiency) where guidelines favor extended anticoagulation.
  • Cohort B
  • Women who are pregnant, currently breastfeeding, or planning pregnancy during the trial or within the defined post treatment period are not eligible.
  • Evidence of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection at Screening, defined as any of the following:
  • Positive hepatitis B surface antigen (HBsAg), or positive total hepatitis B core antibody (anti-HBc) with detectable HBV DNA;
  • Positive hepatitis C virus antibody (anti-HCV) with detectable HCV RNA; or
  • Reactive HIV-1/2 antigen/antibody test confirmed by a positive confirmatory test.
  • Participants who are total anti-HBc-positive must undergo HBV DNA testing, and participants who are anti-HCV-positive must undergo HCV RNA testing. Participants with undetectable HBV DNA or HCV RNA may be eligible provided there is no clinical or laboratory evidence of active liver disease.
  • Planned surgery that may change VTE/bleeding risk during the trial period and no recent surgery (≤2 weeks prior screening).
  • Any serious medical, psychiatric, or social condition that, in the investigator's opinion, would interfere with trial participation, compliance, or interpretation of trial results.
  • eGFR <30 mL/min (calculated per CKD-EPI 2021, expected to be reported in mL/min per 1.73 m2)
  • High bleeding risk, defined as any of the following:
  • Any condition that, in the investigator's judgment, confers an increased risk of clinically significant bleeding.
  • Known intracranial malignancy at high hemorrhage risk, defined as known primary brain tumor, or known intracranial metastases with prior intracranial hemorrhage, known hemorrhagic metastases, or other intracranial lesion judged high risk by the investigator (no protocol-mandated screening imaging).
  • Active or untreated high risk gastrointestinal or GU lesions, including but not limited to active peptic ulcer disease, untreated/high risk esophageal or gastric varices, or GU lesions/tumors associated with active bleeding (eg, macroscopic hematuria from bladder/urinary tract tumor), unless adequately treated and clinically stabilized.
  • Clinically overt bleeding (eg, gastrointestinal bleeding, macroscopic hematuria, epistaxis requiring medical attention, or any bleeding requiring an acute care visit) within 4 weeks prior to screening.
  • Unexplained decrease in hemoglobin ≥2 g/dL within the 2 weeks prior to screening, unless evaluated and a bleeding source has been excluded or treated and clinically stabilized.
  • Red blood cell transfusion within the 2 weeks prior to screening, unless hemoglobin is clinically stable after correction and there is no evidence of ongoing bleeding (A patient is considered as clinically stabilized if there is no clinically overt bleeding for ≥7 days and no planned urgent endoscopic/urologic intervention for bleeding during the immediate treatment initiation period. A hemoglobin stability is defined as no further decrease >1 g/dL over ≥72 hours [without additional transfusion] with the patient being clinically stable).
  • Hepatic disease with coagulopathy, including but not limited to:
  • Ascites, cirrhosis, encephalopathy, or jaundice
  • Hypoalbuminemia <3.5 g/dL
  • Total bilirubin >1.5 × ULN
  • Transaminases >2 × the ULN
  • Biochemical evidence of biliary obstruction
  • Cancer types not eligible as the sole diagnosis:
  • Basal cell or squamous cell carcinoma of the skin only
  • Acute leukemia
  • Myeloproliferative neoplasm

Trial locations and contacts

30 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Rebeckha Magnusson, Head Clinical Operations contact

+46 31 72 07 800

rebeckha.magnusson@ribocure.com

30 sites in 4 countries

Poland11 sites

  • Cardiology Office Individual Specialist Medical Practice Elżbieta Dułak

    Gdynia

    Elzbieta Dulak, Doctor

    Elzbieta Dulak, Doctor

  • Oddział Kardiologii SPS Szpital Zachodni im św Jana Pawła iI

    Grodzisk Mazowiecki

    Janusz Bednarski, Doctor

    Janusz Bednarski, Doctor

  • Uniwersytet Jagiellonski Collegium Medicum

    Krakow

    Grzegorz Kopec, Professor

    Grzegorz Kopec, Professor

  • "Department of Cardiology European Health Center Otwock"

    Otwock

    Marcin Kurzyna, Professor

    Marcin Kurzyna, Professor

  • University Clinical Research Support Center of Medical University in Poznan

    Poznan

    Gabriel Marcin, Professor

    Gabriel Marcin, Professor

  • Clinical Oncology Department, Mazowiecki Szpital Wojewódzki

    Siedlce

    Marta Czeluścińska-Murawiec, Doctor

    Marta Czeluścińska-Murawiec, Doctor

  • Aidport Sp. z o.o.

    Skorzewo

    Michal Kwiatek, Doctor

    Michal Kwiatek, Doctor

  • Zachodniopomorskie Centrum Onkologii

    Szczecin

    Katarzyna Hetman, Doctor

    Katarzyna Hetman, Doctor

  • Centrum Medyczne LUX MED sp zoo ul 1 Sierpnia 8, 02-143 Warszawa

    Warsaw

    Piotr Pruszczyk, Professor

    Piotr Pruszczyk, Professor

  • Klinika Sienna Sp. z o.o.

    Warsaw

    Jacek Opalinski, Doctor

    Jacek Opalinski, Doctor

  • Maria Skłodowska-Curie National Research Institute of Oncology

    Warsaw

    Lucjan Wyrwicz, Professor

    Lucjan Wyrwicz, Professor

Other trials in Poland

Bulgaria8 sites

  • Multiprofile Hospital For Active Treatment - Pazardzhik AD

    Pazardzhik

    Petar Lazov, Doctor

    Petar Lazov, Doctor

  • Specialized Hospital for Active Treatment in Cardiology - Medica Cor EAD

    Rousse

    Dobrin Vasilev, Professor

  • Acibadem City Clinic Tokuda University Hospital EAD

    Sofia

    Milena Staneva, Professor

    Milena Staneva, Professor

  • Multiprofile Hospital for Active Treatment "National Cardiology Hospital" EAD

    Sofia

    Elena Goranova Lazarova, Professor

    Elena Goranova Lazarova, Professor

  • Multiprofile Hospital for Active Treatment "National Cardiology Hospital" EAD

    Sofia

    Nadelin Nikolov, Associate Professor

  • University Hospital for Active Treatment and Emergency Medicine N.I. Pirogov EAD

    Sofia

    Rossen Stoytchev, Associate Professor

    Rossen Stoytchev, Associate Professor

  • University Multiprofile Hospital for Active Treatment "Alexandrovska"

    Sofia

    Kirik Karamfiloff, Professor

    Kiril Karamfiloff, Professor

  • Multiprofile District Hospital for Active Treatment "Dr. Stefan Cherkezov" AD

    Veliko Tarnovo

    Shkvarla Lyuboslav, Doctor

    Shkvarla Lyuboslav, Doctor

Other trials in Bulgaria

Romania7 sites

  • Gral Medical - Oncofort Pitesti

    Piteşti

    Adela Lucia Chirila, Doctor

    Adela Lucia Chirila, Doctor

  • Satu Mare County Emergency Hospital

    Satu Mare

    Maria Melinda Kurtinecz, Doctor

    Maria Melinda Kurtinecz, Doctor

  • Spitalul European Polisano - Constitutiei Sibiu

    Sibiu

    Victor Nimirceag, Doctor

    Victor Nimirceag, Doctor

  • Sigmedical Services S.R.L.

    Suceava

    Doina Elena Ganea, Professor

    Doina Elena Ganea, Professor

  • Centrul Medical Cardiomed

    Târgu Mureş

    Imre Benedek, Professor

    Imre Benedek, Professor

  • Spitalul Clinic Judeţean Mureş

    Târgu Mureş

    Attila Frigy, Associate Professor

    Attila Frigy, Associate Professor

  • Institutului de Boli Cardiovasculare Timişoara

    Timișoara

    Dan Gaita, Professor

    Dan Gaita, Professor

Other trials in Romania

France4 sites

  • Centre Oncologie Radiotherapie (CORT 37)

    Chambray-lès-Tours

    Pierre Combe, Doctor

    Pierre Combe, Doctor

  • Louis-Mourier (AP-HP)

    Colombes

    Isabelle Mahe, Doctor

    Isabelle Mahe, Doctor

  • CHU de Grenoble

    Grenoble

    Gilles Pernod, Professor

    Gilles Pernod, Professor

  • Hôpital Européen Georges Pompidou (HEGP)

    Paris

    Olivier Sanchez, Professor

    Olivier Sanchez, Professor

Other trials in France

About this study

Official title: Randomized, Double-blind, Phase II Trial of Vortosiran to Evaluate Safety, Tolerability, and Pharmacodynamic Efficacy in Participants With Prior Venous Thromboembolism After Completion of Initial Anticoagulant Therapy (Cohort A) and in Cancer Patients at High Risk of Venous Thromboembolism (Cohort B)

Blood clots remain a serious cause of illness and death. Long-term treatment and prevention of these clots with blood thinners is often limited by bleeding risk, drug interactions, and daily dosing, leading many patients to stop treatment early. Both cancer and chemotherapy further increase the risk of clot formation.

Vortosiran is an injectable therapy that lowers Factor XI (one of the body's natural clotting helpers) production in the liver, leading to a strong and long-lasting reduction in blood clotting activity with less risk of bleeding compared to current available treatments. Studies conducted so far have shown that vortosiran is safe and shows a dose-dependent Factor XI suppression (that is, a higher dose results in a higher level of suppression) that lasts for several months, supporting testing using a limited number of injections in patients who are at higher risk of blod clot formation.

This study aims to study how safe and effective vortosiran is in patients who have had blood clots in the past and in cancer patients who are at high risk of developing blood clots.

Read the detailed description

Venous thromboembolism, encompassing DVT and PE, is a common condition with a durable risk of recurrence after completion of initial therapy with systemic anticoagulation. In a systematic review and meta-analysis of patients with a first unprovoked VTE who completed at least 3 months of anticoagulant therapy and then discontinued treatment, the cumulative incidence of recurrent VTE was approximately 10% in the first year, 25% at 5 years, and 36% at 10 years, with recurrent events carrying measurable case fatality (Khan et al, 2019). Decisions about extended therapy are frequently individualized because continued anticoagulation reduces VTE recurrence but also exposes patients to ongoing bleeding risk, treatment burden, and complexity of care.

Venous thromboembolism, including in patients with cancer and chemotherapy, remains a major cause of morbidity and mortality. Despite effective anticoagulants, long-term management is constrained by clinically meaningful bleeding risk, drug-drug interactions with anticoagulation therapy, and the need for continuous dosing and adherence. Furthermore, many patients discontinue therapy when they perceive recurrence risk to be moderate or when bleeding risk, treatment burden, or patient preference argues against indefinite anticoagulation. These combined factors constitute an unmet need for a convenient strategy that can reduce recurrent VTE risk with a lower risk of bleeding.

Vortosiran is a subcutaneously administered siRNA designed to selectively inhibit hepatic synthesis of FXI, resulting in robust and durable suppression of FXI activity. FXI inhibition is novel and innovative anti-thrombotic strategy inhibiting blood clot formation by the intrinsic pathway without interfering with hemostatic control through the extrinsic and commen clotting pathways. Thereby reducing blood clot formation and VTE without increasing the risk of bleeding compared to current available anti-coagulant treatments.

This Phase II trial is designed to establish dose-related FXI suppression, characterize safety with repeated dosing, and generate an initial signal on clinical outcomes in two VTE prevention settings.

This multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase II trial will be conducted in two cohorts. Cohort A and Cohort B are independently enrolled and randomized. Participants are randomized (2:2:1) to low-dose vortosiran, high-dose vortosiran, or matched placebo, with dosing on Day X and Day Y and follow-up through Week 56. This trial aims to evaluate vortosiran in two complementary populations where FXI suppression could provide clinically relevant benefit and where the risk-benefit of conventional anticoagulation is often challenging.

  • Cohort A (post-VTE, with participants judged to be at equipoise for extended therapy): Participants have completed 3 to 12 months of standard anticoagulation for symptomatic proximal DVT and/or PE as originally prescribed, and have had no recurrence during that initial treatment period. The cohort is restricted to patients for whom discontinuation of anticoagulation is consistent with local standard of care and where there is true equipoise about extended therapy vs only follow-up and observation.
  • Cohort B (active cancer; high VTE risk): Ambulatory patients initiating a new course of systemic chemotherapy and with intermediate to high VTE risk (Khorana score ≥2), but no history of prior VTE.
Being tested
Vortosiran, Placebo
Keywords
VTE, Venous Thromboembolism, siRNA, Phase 2, RCT
Medical subject headings
Venous Thromboembolism, Neoplasms, Pulmonary Embolism, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VortosiranDrug

    Vortosiran, active drug.

  • PlaceboDrug

    Placebo that is identical in appearance of active IMP.

Study groups in NCT07850453
Study groupRoleWhat they receive
Low-dose groupActive comparatorNot described
Receives: Drug: Vortosiran
High-dose groupActive comparatorNot described
Receives: Drug: Vortosiran
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary objective

    To evaluate the effect of two dose levels of vortosiran on coagulation Factor XI (FXI) activity.

    Measured: At Week 8

  2. Primary endpoint

    Percentage change from baseline in FXI activity, compared with placebo.

    Measured: Baseline to Week 8.

Secondary outcomes (5)

  1. Secondary objective

    To evaluate the safety of vortosiran at two dose levels.

    Measured: Up to week 56

  2. Secondary objective

    To assess the plasma exposure of vortosiran after dosing

    Measured: 0 [pre-dose] to 24 hours after dosing.

  3. Secondary objective

    To evaluate the effect of 2 dose levels of vortosiran on FXI antigen concentration.

    Measured: At week 16

  4. Secondary Objective

    To evaluate the effect of 2 dose levels of vortosiran on specific blood coagulation test aPTT.

    Measured: At week 16

  5. Secondary objective

    To evaluate the effect of 2 doses of vortosiran on specific blood clotting test PT-INR.

    Measured: At week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionJul 2027 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase II trial will be conducted in two cohorts. Cohort A and Cohort B are independently enrolled and randomized. Participants are randomized (2:2:1) to low-dose vortosiran, high-dose vortosiran, or matched placebo, with dosing on Day X and Day Y and follow-up through Week 56. This trial aims to evaluate vortosiran in two complementary populations where FXI suppression could provide clinically relevant benefit and where the risk-benefit of conventional anticoagulation is often challenging.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07850453
Sponsor's protocol ID
RC03T003
Other IDs
2026-525479-15
Status last verified
Sep 2026
First submitted
17 Sep 2026
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Salomon O, Steinberg DM, Dardik R, Rosenberg N, Zivelin A, Tamarin I, Ravid B, Berliner S, Seligsohn U. Inherited factor XI deficiency confers no protection against acute myocardial infarction. J Thromb Haemost. 2003 Apr;1(4):658-61. doi: 10.1046/j.1538-7836.2003.00195.x.

    PubMed 12871398

  • Doggen CJ, Rosendaal FR, Meijers JC. Levels of intrinsic coagulation factors and the risk of myocardial infarction among men: Opposite and synergistic effects of factors XI and XII. Blood. 2006 Dec 15;108(13):4045-51. doi: 10.1182/blood-2005-12-023697. Epub 2006 Aug 24.

    PubMed 16931632

  • Konings J, Govers-Riemslag JW, Spronk HM, Waltenberger JL, ten Cate H. Activation of the contact system in patients with a first acute myocardial infarction. Thromb Res. 2013 Jul;132(1):138-42. doi: 10.1016/j.thromres.2013.05.016. Epub 2013 Jun 7.

    PubMed 23746628

  • Paszek E, Pociask E, Zabczyk M, Piorkowski A, Butenas S, Legutko J, Undas A. Active factor XI is associated with the risk of cardiovascular events in stable coronary artery disease patients. Atherosclerosis. 2022 Apr;346:124-132. doi: 10.1016/j.atherosclerosis.2022.02.009. Epub 2022 Feb 11.

    PubMed 35246318

  • Lewandowska MD, Connors JM. Factor XI Deficiency. Hematol Oncol Clin North Am. 2021 Dec;35(6):1157-1169. doi: 10.1016/j.hoc.2021.07.012. Epub 2021 Sep 15.

    PubMed 34535287

  • Key NS. Epidemiologic and clinical data linking factors XI and XII to thrombosis. Hematology Am Soc Hematol Educ Program. 2014 Dec 5;2014(1):66-70. doi: 10.1182/asheducation-2014.1.66. Epub 2014 Nov 18.

    PubMed 25696836

  • Khorana AA, Kuderer NM, Culakova E, Lyman GH, Francis CW. Development and validation of a predictive model for chemotherapy-associated thrombosis. Blood. 2008 May 15;111(10):4902-7. doi: 10.1182/blood-2007-10-116327. Epub 2008 Jan 23.

    PubMed 18216292

  • Khan F, Rahman A, Carrier M, Kearon C, Weitz JI, Schulman S, Couturaud F, Eichinger S, Kyrle PA, Becattini C, Agnelli G, Brighton TA, Lensing AWA, Prins MH, Sabri E, Hutton B, Pinede L, Cushman M, Palareti G, Wells GA, Prandoni P, Buller HR, Rodger MA; MARVELOUS Collaborators. Long term risk of symptomatic recurrent venous thromboembolism after discontinuation of anticoagulant treatment for first unprovoked venous thromboembolism event: systematic review and meta-analysis. BMJ. 2019 Jul 24;366:l4363. doi: 10.1136/bmj.l4363.

    PubMed 31340984

  • Walsh M, Bethune C, Smyth A, Tyrwhitt J, Jung SW, Yu RZ, Wang Y, Geary RS, Weitz J, Bhanot S; CS4 Investigators. Phase 2 Study of the Factor XI Antisense Inhibitor IONIS-FXIRx in Patients With ESRD. Kidney Int Rep. 2021 Nov 24;7(2):200-209. doi: 10.1016/j.ekir.2021.11.011. eCollection 2022 Feb.

    PubMed 35155859

  • Carrier M, Abou-Nassar K, Mallick R, Tagalakis V, Shivakumar S, Schattner A, Kuruvilla P, Hill D, Spadafora S, Marquis K, Trinkaus M, Tomiak A, Lee AYY, Gross PL, Lazo-Langner A, El-Maraghi R, Goss G, Le Gal G, Stewart D, Ramsay T, Rodger M, Witham D, Wells PS; AVERT Investigators. Apixaban to Prevent Venous Thromboembolism in Patients with Cancer. N Engl J Med. 2019 Feb 21;380(8):711-719. doi: 10.1056/NEJMoa1814468. Epub 2018 Dec 4.

    PubMed 30511879

  • Khorana AA, Francis CW, Culakova E, Kuderer NM, Lyman GH. Thromboembolism is a leading cause of death in cancer patients receiving outpatient chemotherapy. J Thromb Haemost. 2007 Mar;5(3):632-4. doi: 10.1111/j.1538-7836.2007.02374.x. No abstract available.

    PubMed 17319909

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vortosiran in people with Venous Thromboembolism (VTE) and Cancer, run by Ribocure Pharmaceuticals AB at 30 sites in 4 countries.

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 23 inclusion and 44 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: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Poland, Bulgaria, Romania, France. 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 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?

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?

Contact Rebeckha Magnusson, Head Clinical Operations (+46 31 72 07 800, rebeckha.magnusson@ribocure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary objective (time frame: At Week 8). The study lists 2 primary outcomes in all. 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 NCT07850453, which also lists 11 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 30 Sep 2026.

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