Long-Term Innohep® Treatment Versus a Vitamin K Antagonist (Warfarin) for the Treatment of Venous Thromboembolism (VTE) in Cancer

This study is currently recruiting participants.

Verified December 2012 by LEO Pharma

Sponsor:

Information provided by (Responsible Party):

LEO Pharma

ClinicalTrials.gov Identifier:

NCT01130025

First received: May 24, 2010

Last updated: December 21, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 24, 2010

Last Updated Date

December 21, 2012

Start Date ^ICMJE

August 2010

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Composite end-point represented by the time in days from randomisation to the first occurrence of VTE [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Symptomatic non-fatal DVTs.
Symptomatic non-fatal PEs.
Fatal PE.
Incidental proximal DVT (popliteal vein or higher).
Incidental proximal PE (segmental arteries or larger).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01130025 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time in days from randomisation to the first occurrence of VTE. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

The 5 individual components of the composite primary efficacy endpoint.
A composite endpoint of symptomatic DVT and/or PE, including fatal PE.

Safety endpoints will consist of bleeding and overall mortality

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Long-Term Innohep® Treatment Versus a Vitamin K Antagonist (Warfarin) for the Treatment of Venous Thromboembolism (VTE) in Cancer

Official Title ^ICMJE

Efficacy and Safety of Long-Term (6 Months) Innohep® Treatment Versus Anticoagulation With a Vitamin K Antagonist (Warfarin) for the Treatment of Acute Venous Thromboembolism in Cancer Patients / IN 0901 INT

Brief Summary

The purpose of this study is to assess the efficacy and safety of Innohep® in preventing the recurrence of VTE in patients with active cancer who have had an acute VTE episode.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Venous Thromboembolism

Intervention ^ICMJE

Drug: Warfarin
Tablets. Once daily for 6 months (180 days) to maintain therapeutic international normalised ratio (INR) levels in combination with initial (5-10 days) overlapping treatment with Innohep®.
Drug: Innohep®
Solution for sub-cutaneous injection, pre-filled syringes. Once daily for 6 months (180 days). 175 anti Xa IU/kg.

Study Arm (s)

Experimental: Innohep®
Long-term treatment with Innohep® only.

Intervention: Drug: Innohep®
Active Comparator: Warfarin
Oral treatment with warfarin in combination with overlapping initial (5 to 10 days) treatment with Innohep®.

Intervention: Drug: Warfarin

Publications *

Not Provided

* 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

Recruiting

Estimated Enrollment ^ICMJE

900

Estimated Completion Date

April 2014

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with a diagnosis of active cancer.
Symptomatic and objectively confirmed VTE.
≥ 18 years of age or above the legal age of consent as per country specific regulations.
Patients with Eastern Co-operative Oncology Group (ECOG) performance status of 0, 1 or 2.
Signed informed consent.

Exclusion Criteria:

Life expectancy < 6 months.
Patients with basal cell carcinoma or non-melanoma skin cancer.
Creatinine clearance ≤ 20 ml/min.
Contra-indications to anticoagulation.
Known hypersensitivity to the investigational product (Innohep®) or the reference product (warfarin).
History of heparin-induced thrombocytopenia (HIT).
Pre-randomisation therapeutic anticoagulant treatment for acute VTE administered for more than 72 hours prior to randomisation.
Patients unlikely to comply with the protocol.
Participation in another interventional study.
Pregnant or breast-feeding women.
Women of childbearing potential.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Lars Rosendal, MSc, PhD	+45 41883006	lars.rosendal@leo-pharma.com
Contact: Charlotte Irps	+44 1844276310	charlotte.irps@leo-pharma.com

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01130025

Other Study ID Numbers ^ICMJE

IN 0901 INT, 2009-018141-20

Has Data Monitoring Committee

Yes

Responsible Party

LEO Pharma

Study Sponsor ^ICMJE

LEO Pharma

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Agnes Y. Y. Lee, MD, MSc, FRCPC

Director of Thrombosis, Division of Hematology, University of British Columbia, Canada

Information Provided By

LEO Pharma

Verification Date

December 2012

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

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