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

Venous Thromboembolism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01130025
• Other study ID #: IN 0901 INT
• Secondary ID: 2009-018141-20
• Status: Completed
• Phase: Phase 3
• First received: May 24, 2010
• Last updated: June 13, 2014
• Start date: August 2010
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustria: Agency for Health and Food SafetyBrazil: National Health Surveillance AgencyBulgaria: Bulgarian Drug AgencyCanada: Health CanadaChile: Instituto de Salud Pública de ChileColombia: National Institutes of HealthCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyEgypt: Ministry of Health, Drug Policy and Planning CenterGermany: Federal Institute for Drugs and Medical DevicesGreece: National Organization of MedicinesGuatemala: Ministry of Public Health and Social AssistanceIndia: Central Drugs Standard Control OrganizationIsrael: Ministry of HealthItaly: Ministry of HealthJordan: Jordanian Food and Drug AdministrationLatvia: State Agency of MedicinesLebanon: Ministry of Public HealthHong Kong: Ministry of HealthMexico: Ministry of HealthPeru: Instituto Nacional de SaludPoland: The Central Register of Clinical TrialsPortugal: National Pharmacy and Medicines InstituteRomania: National Medicines AgencyRussia: Ministry of Health of the Russian FederationSaudi Arabia: Ministry of HealthSerbia and Montenegro: Agency for Drugs and Medicinal DevicesSlovakia: State Institute for Drug ControlSouth Africa: Medicines Control CouncilSouth Korea: Korea Food and Drug Administration (KFDA)Spain: Agencia Española de Medicamentos y Productos SanitariosTaiwan: Department of HealthThailand: Ministry of Public HealthUkraine: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

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

Locations

Country	Name	City	State
Canada	Diamond Health Care Centre	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	6 months	Yes