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

NCT01130025 | Completed Phase 3 DMC

• 2 other identifiers: IN 0901 INT2009-018141-20
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (1)

• 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).

  6 months

Secondary Outcomes (1)

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

  6 months

Study Arms (2)

Innohep®

EXPERIMENTAL

Long-term treatment with Innohep® only.

Drug: Innohep®

Warfarin

ACTIVE COMPARATOR

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

Drug: Warfarin

Interventions

Warfarin DRUG

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®.

Warfarin

Innohep® DRUG

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

Innohep®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Diamond Health Care Centre

Vancouver, British Columbia, BC V5Z 1M9, Canada

Location

Related Publications (4)

• 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.

  PMID: 34878173 DERIVED

• 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.

  PMID: 29618162 DERIVED

• 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.

  PMID: 26284719 DERIVED

• 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.

  PMID: 23764005 DERIVED

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Warfarin; Tinzaparin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Agnes Y. Y. Lee, MD, MSc, FRCPC

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2010
• First Posted: May 25, 2010
• Study Start: August 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: February 24, 2025

Record last verified: 2014-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)