A study to learn more about how well BAY 3018250 works and how safe it is for people with proximal deep vein thrombosis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bayer AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

20 Dec 2023 → 3 Dec 2025

Decision date (initial)

2023-11-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Funds of Bayer AG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Pharmacodynamic, Pharmacokinetic, Efficacy, Safety, Pharmacogenetic

The primary objectives are to quantify the effect of BAY 3018250 on clot lysis in patients with proximal DVT, and to assess the safety of BAY 3018250 in patients with proximal DVT.

Secondary objectives 1

1. The secondary objective is to quantify the effect of BAY 3018250 on clot lysis in patients with proximal DVT based on additional endpoints

Conditions and MedDRA coding

Thrombolysis of symptomatic proximal vein thrombosis

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Male and female (if postmenopausal or hysterectomized) aged 18 years or older
2. Acute symptomatic proximal deep vein thrombosis (DVT) documented by compression ultrasound (CUS) and all of the following: a. duration of symptoms 14 days or less b. Proximal DVT involving at least 1 of the following proximal veins: the popliteal vein, the femoral vein, the common femoral vein and the external iliac vein c. adequate visualization of the most proximal end of the thrombus d. receiving therapeutic dose anticoagulation with LMWHs and/or DOACs according to the respective product labels
3. Measured body weight within 50 to 130 kg
4. Signed informed consent

Exclusion criteria 7

1. Acute symptomatic PE requiring systemic or catheter-directed thrombolytic therapy, catheter-directed mechanical thrombectomy, or surgical embolectomy
2. Active bleeding or high risk for bleeding (at the discretion of the investigator)
3. Recent (<3 months) ischemic stroke, myocardial infarction, intracranial hemorrhage, or major surgery or severe trauma (at the discretion of the investigator)
4. Active cancer, i.e., locally active, regionally invasive or metastatic and/or anticancer therapy within the last 6 months, except basal cell or squamous cell carcinoma
5. Therapeutic-dose anticoagulants for > 72 hours before randomization, or current use of vitamin K antagonists
6. Planned or current use of the following medications: Planned or current use of the following medications: a. Any antiplatelet therapy, except ASA ≤100 mg/day, b. Antifibrinolytic drugs, c.Therapeutic antibodies
7. Male participants with WOCBP partners unwilling to use highly effective contraception from start of study intervention until end of study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Area under the curve AUCn(6h-30d) of the ratio to baseline of clot burden, as assessed by repeated quantitative ultrasound at 6h, 24h, Day 7 and Day 30
2. Number of participants with composite of major and clinically relevant non-major (CRNM) bleeding events (ISTH definition) up to Day 15

Secondary endpoints 4

1. Ratio to baseline of clot burden, as assessed by repeated quantitative ultrasound at 6h, 24h, Day 7, Day 30 and Day 90, respectively.
2. Change from baseline in leg pain severity at 6h, 24h, Day 7, Day 30 and Day 90 (Likert pain scale)
3. Change from baseline in post- venous thromboembolism functional status (PVFS) scale at Day 7, Day 30 and Day 90
4. Number participants with recurrent venous thromboembolism (VTE) up to Day 90

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bayer AG

Sponsor organisation

Bayer AG

Address

-

City

Leverkusen

Postcode

51368

Country

Germany

Scientific contact point

Organisation

Bayer AG

Contact name

Therapeutic Area Head

Public contact point

Organisation

Bayer AG

Contact name

Therapeutic Area Head

Third parties 6

Locations

11 EU/EEA countries · 84 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 99 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

30 submissions — initial application plus substantial / non-substantial modifications