Cancer Clinical Trial
Official title:
A Multinational, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AVE5026 in the Prevention of Venous Thromboembolism (VTE) in Cancer Patients at High Risk for VTE and Who Are Undergoing Chemotherapy
The primary objective was to compare the efficacy of once daily subcutaneous injections of
Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism [VTE]
in cancer patients at high risk for VTE and who were undergoing chemotherapy.
The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to
document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of
VTE and to assess the survival status at one year in this population.
Randomization had to take place just prior to the first study drug injection (randomization
ratio 1:1).
The study period per participant was variable depending on the duration of chemotherapy. It
included:
- a screening period up to 3 weeks,
- a double-blind treatment period,
- a follow-up period of 1 month.
Study end date was at the latest 7 months following the randomization of the last
participant (6 months treatment and 1 month follow-up).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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