Status:
UNKNOWN
A Study of Dabigatran Etexilate as Primary Treatment of Malignancy Associated Venous Thromboembolism
Lead Sponsor:
The University of Hong Kong
Conditions:
Venous Thromboembolism
Deep Vein Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This trial aims at determining if dabigatran is effective in the treatment of malignancy associated VTE. Tolerance and safety of dabigatran will also be assessed. This is a single armed trial of dabi...
Detailed Description
Patients with malignancies are at increased risks of venous thromboembolism (VTE). The annual incidence of VTE in cancer patients is 0.5%, which is 5-fold more than the general population . Low molecu...
Eligibility Criteria
Inclusion
- are aged 18 years or above;
- have acute symptomatic deep vein thrombosis or pulmonary embolism with objective confirmation;
- have active cancer, which is defined as a diagnosis of cancer other than basal cell or squamous cell carcinoma of skin within six months before enrollment, any treatment for cancer within the previous six months or recurrent or metastatic cancer.
- Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year.
- Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
Exclusion
- have Eastern Cooperative Oncology Group (ECOG) performance status score of \> 2 at the time of randomization;
- have life expectancy of less than 3 months;
- have active bleeding, are at high risk of bleeding, or have contraindications to anticoagulant treatment;
- receive thrombectomy or fibrinolytic agent to treat the current episode of VTE;
- receive more than 72 hours pre-treatment with therapeutic dosages of anticoagulant treatment prior to randomization to treat the current VTE episode;
- are already on long term oral anticoagulation;
- are on low molecular weight heparin for indications other than VTE;
- have platelet count of less than 100 x 109/L;
- are on dual antiplatelet therapy;
- have a serum creatinine level of more than 220 umol/L or have a calculated creatinine clearance (CrCl) of less than 30 ml/min;
- have alanine aminotransferase level more than 2 times the upper limit of normal range or cirrhosis;
- have history of heparin induced thrombocytopenia;
- are on treatment of potent inhibitors or inducers of P-glycoprotein.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT03240120
Start Date
September 1 2017
End Date
December 31 2021
Last Update
April 17 2019
Active Locations (1)
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1
The University of Hong Kong
Hong Kong, Hong Kong