Back to results

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

Primary Purpose

Venous Thromboembolism

Status

Completed

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Warfarin

Innohep®

About this trial

This is an interventional treatment trial for Venous Thromboembolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Diamond Health Care Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Innohep®

Warfarin

Arm Description

Long-term treatment with Innohep® only.

Oral treatment with warfarin in combination with overlapping initial (5 to 10 days) treatment with Innohep®.

Outcomes

Primary Outcome Measures

Composite end-point represented by the time in days from randomisation to the first occurrence of VTE

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

Secondary Outcome Measures

Time in days from randomisation to the first occurrence of VTE.

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

Full Information

NCT ID

NCT01130025

First Posted

May 24, 2010

Last Updated

June 13, 2014

Sponsor

LEO Pharma

1. Study Identification

Unique Protocol Identification Number

NCT01130025

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LEO Pharma

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Thromboembolism

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

900 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Innohep®

Arm Type

Experimental

Arm Description

Long-term treatment with Innohep® only.

Arm Title

Warfarin

Arm Type

Active Comparator

Arm Description

Oral treatment with warfarin in combination with overlapping initial (5 to 10 days) treatment with Innohep®.

Intervention Type

Drug

Intervention Name(s)

Warfarin

Intervention Description

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®.

Intervention Type

Drug

Intervention Name(s)

Innohep®

Intervention Description

Solution for sub-cutaneous injection, pre-filled syringes. Once daily for 6 months (180 days). 175 anti Xa IU/kg.

Primary Outcome Measure Information:

Title

Composite end-point represented by the time in days from randomisation to the first occurrence of VTE

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Time in days from randomisation to the first occurrence of VTE.

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Diamond Health Care Centre

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

BC V5Z 1M9

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

34878173

Citation

Kahale LA, Matar CF, Hakoum MB, Tsolakian IG, Yosuico VE, Terrenato I, Sperati F, Barba M, Schunemann H, Akl EA. Anticoagulation for the initial treatment of venous thromboembolism in people with cancer. Cochrane Database Syst Rev. 2021 Dec 8;12(12):CD006649. doi: 10.1002/14651858.CD006649.pub8.

Results Reference

derived

PubMed Identifier

29618162

Citation

Bauersachs R, Lee AYY, Kamphuisen PW, Meyer G, Janas MS, Jarner MF, Khorana AA; CATCH Investigators. Renal Impairment, Recurrent Venous Thromboembolism and Bleeding in Cancer Patients with Acute Venous Thromboembolism-Analysis of the CATCH Study. Thromb Haemost. 2018 May;118(5):914-921. doi: 10.1055/s-0038-1641150. Epub 2018 Apr 4.

Results Reference

derived

PubMed Identifier

26284719

Citation

Lee AYY, Kamphuisen PW, Meyer G, Bauersachs R, Janas MS, Jarner MF, Khorana AA; CATCH Investigators. Tinzaparin vs Warfarin for Treatment of Acute Venous Thromboembolism in Patients With Active Cancer: A Randomized Clinical Trial. JAMA. 2015 Aug 18;314(7):677-686. doi: 10.1001/jama.2015.9243. Erratum In: JAMA. 2017 Nov 28;318(20):2048.

Results Reference

derived

PubMed Identifier

23764005

Citation

Lee AY, Bauersachs R, Janas MS, Jarner MF, Kamphuisen PW, Meyer G, Khorana AA; CATCH Investigators. CATCH: a randomised clinical trial comparing long-term tinzaparin versus warfarin for treatment of acute venous thromboembolism in cancer patients. BMC Cancer. 2013 Jun 13;13:284. doi: 10.1186/1471-2407-13-284.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs