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Cancer Venous Thromboembolism (VTE)

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ClinicalTrials.gov Identifier: NCT02073682
Recruitment Status : Completed
First Posted : February 27, 2014
Results First Posted : October 24, 2018
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Tracking Information
First Submitted Date  ICMJE February 25, 2014
First Posted Date  ICMJE February 27, 2014
Results First Submitted Date  ICMJE September 26, 2018
Results First Posted Date  ICMJE October 24, 2018
Last Update Posted Date March 6, 2019
Actual Study Start Date  ICMJE July 16, 2015
Actual Primary Completion Date September 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 25, 2014)
  • incidence of recurrent VTE at end of study [ Time Frame: 6 months ]
    primary efficacy outcome is incidence of recurrent VTE at end of study
  • incidence of of clinically relevant bleeding while on treatment [ Time Frame: 6 months ]
    primary safety outcome is incidence of clinically relevant bleeding while on treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
  • Number of Participants With Adjudicated Major Bleeding Events While on Treatment [ Time Frame: 12 months ]
    The primary safety endpoint was major bleeding events during the On-Treatment Study Period (defined as on-study drug or up to 3 days after the last dose of study drug).
  • Number of Participants With Recurrent Venous Thromboembolism (VTE) During the Overall Study Period [ Time Frame: 12 months ]
  • Number of Participants With Recurrent Deep Vein Thrombosis (DVT) During the Overall Study Period [ Time Frame: 12 months ]
  • Number of Participants With Recurrent Non-Fatal Pulmonary Embolism (PE) During the Overall Study Period [ Time Frame: 12 months ]
  • Number of Participants With VTE-Related Death [ Time Frame: 12 months ]
  • Number of Participants With Recurrent VTE, Major Bleed or All-Cause Death [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cancer Venous Thromboembolism (VTE)
Official Title  ICMJE A Phase 3b, Prospective, Randomized, Open-label, Blind Evaluator (PROBE) Study Evaluating the Efficacy and Safety of (LMW) Heparin/Edoxaban Versus Dalteparin in Venous Thromboembolism Associated With Cancer
Brief Summary The primary objective is to demonstrate the non-inferiority of edoxaban (preceded by a short course of LMWH) compared with dalteparin for the prevention of the combined outcome of recurrent venous thromboembolism (VTE) or major bleeding in subjects with VTE associated with cancer during a 12-month study period. If non-inferiority is established, LMWH/edoxaban will be compared with dalteparin for superiority.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Venous Thromboembolism (VTE)
  • Deep Vein Thrombosis (DVT)
  • Pulmonary Embolism (PE)
  • Cancer
Intervention  ICMJE
  • Drug: Edoxaban
    After the 5 day treatment with LMWH, patients receive edoxaban 60 mg once daily (QD) as 2 × 30 mg tablets (or 1 x 30 mg tablet QD for patients requiring dose adjustment) for the remainder of the treatment period.
    Other Name: DU-176b
  • Drug: Dalteparin
    Dalteparin was administered via subcutaneous injection at a dose of 200 IU/kg (maximum daily dose 18,000 IU) for 30 days, and at a dose of 150 IU/kg from Day 31 to the end of treatment.
    Other Name: Active comparator
  • Drug: Low molecular weight heparin
    Therapeutic doses of subcutaneous LMWH were administered for at least 5 days (to patients in the edoxaban group); this 5-day period may have included the pre-randomization LMWH (if applicable). The choice of parenteral LMWH was up to the treating physician.
    Other Name: LMWH
Study Arms  ICMJE
  • Experimental: Edoxaban group
    After 5 days of low molecular weight heparin (LMWH), patients receive edoxaban treatment daily - tablet for oral use
    Interventions:
    • Drug: Edoxaban
    • Drug: Low molecular weight heparin
  • Active Comparator: Dalteparin group
    Participants receive Dalteparin treatment daily -solution for subcutaneous injection
    Intervention: Drug: Dalteparin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2018)
1046
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 15, 2017
Actual Primary Completion Date September 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subjects with age ≥ 18 years or the otherwise legal lower age according to the country of residence;
  • Confirmed acute lower extremity proximal DVT or PE for which long term treatment with low molecular weight heparin (LMWH) is indicated;
  • Cancer, other than basal-cell or squamous-cell carcinoma of the skin;
  • Able to provide written informed consent.

Exclusion Criteria:

  • Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current (index) episode of DVT and/or PE;
  • Treatment with therapeutic doses of an anticoagulant other than that used for pretreatment of the current (index) VTE episode prior to randomization;
  • Active bleeding or high risk for bleeding contraindicating treatment with LMWH or edoxaban;
  • Any other contraindication listed in the local labeling of dalteparin, enoxaparin, or edoxaban;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Hungary,   Italy,   Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02073682
Other Study ID Numbers  ICMJE DU176b-D-U311
2014-004708-30 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://vivli.org/ourmember/daiichi-sankyo/
Responsible Party Daiichi Sankyo, Inc.
Study Sponsor  ICMJE Daiichi Sankyo, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Leader Daiichi Sankyo, Inc.
PRS Account Daiichi Sankyo, Inc.
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP