Clinical Trials Register

Summary
EudraCT Number:	2015-001478-16
Sponsor's Protocol Code Number:	CONKO-011_AIO-SUP-0115/ass.
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Temporarily Halted
Date on which this record was first entered in the EudraCT database:	2015-09-09
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2015-001478-16

A.3

Full title of the trial

Rivaroxaban in the treatment of venous thrombembolism (VTE) in cancer patients – a randomized phase III Study

Randomisierte Phase III Studie zum Stellenwert von Rivaroxaban zur Behandlung venöser Thrombosen bei Patienten mit aktiver maligner Erkrankung

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

The role of Rivaroxaban in the treatment of tumor patients with thrombosis

Rivaroxaban in der Behandlung von Tumorpatienten mit Thrombosen

A.3.2

Name or abbreviated title of the trial where available

CONKO-011

A.4.1

Sponsor's protocol code number

CONKO-011_AIO-SUP-0115/ass.

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	AIO-Studien-gGmbH
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	AIO Studien gGmbH
B.4.2	Country	Germany
B.4.1	Name of organisation providing support	Bayer Vital GmbH
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	CONKO-study group
B.5.2	Functional name of contact point	clinical research group Charite
B.5.3	Address:
B.5.3.1	Street Address	Augustenburger Platz 1
B.5.3.2	Town/ city	Berlin
B.5.3.3	Post code	13353
B.5.3.4	Country	Germany
B.5.4	Telephone number	4930450553222
B.5.5	Fax number	4930450553959
B.5.6	E-mail	conko-studien@charite.de

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Xarelto
D.2.1.1.2	Name of the Marketing Authorisation holder	Bayer Health Care AG
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Xarelto
D.2.1.1.2	Name of the Marketing Authorisation holder	EU/1/08/472/011 – 016, EU/1/08/472/023
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Clexane
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi Aventis
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Innohep
D.2.1.1.2	Name of the Marketing Authorisation holder	Leo Pharma
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 5
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Fragmin
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 6
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Mono-Embolex
D.2.1.1.2	Name of the Marketing Authorisation holder	Aspen
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 7
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Fraxiparin
D.2.1.1.2	Name of the Marketing Authorisation holder	Glaxo Smith Klein
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 8
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Fraxodi
D.2.1.1.2	Name of the Marketing Authorisation holder	Aspen
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for infusion in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Tumor patients with active cancer and
newly diagnosed thrombembolic events were randomised to receive
either Rivaroxaban
or the standard treatment with low-molecular heparine

Tumorpatienten mit aktiver Erkrankung und
einem neu aufgetretenen thrombembolischen Ereignis erhalten randomisiert
Rivaroxaban oder
die Standardtherapie mit niedermolekularem Heparin

E.1.1.1

Medical condition in easily understood language

Tumor patients with newly diagnosed thrombosis were treated either with Rivaroxaban or with low-molecular heparine (the actual standard treatment)

Tumorpatienten mit einem neu aufgetretener Thrombose oder Lungenembolie werden entweder mit Rivaroxaban oder einem niedermolekularem Heparin (der aktuelle Therapiestandard) behandelt

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Patient-reported treatment satisfaction (convenience) with Rivaroxaban in the treatment of acute VTE in cancer patients in comparison with the standard treatment with low molecular weight heparin (LMWH)

Behandlungszufriedenheit während der Therapie mit Rivaroxaban (Xarelto®) von akuten venösen Thromboembolien (VTE) bei Patienten mit aktiver maligner Erkrankung im Vergleich zur Standardbehandlung mit niedermolekularem Heparin (LMWH)

E.2.2

Secondary objectives of the trial

Rate of symptomatic VTE-recurrence within 12 weeks
exploratory analysis for patients with treatment “on protocol” (complete treatment exposure for 12 weeks)
exploratory analysis for “time on treatment”
Subgroup analysis with regard to Pulmonary embolism (PE,) VTE recurrence and bleedings (major, clinically relevant, minor) according to stratification characteristics
Rate of myocardial infarction
Rate of ischemic stroke
Compliance
Overall mortality 3 and 6 months after randomization
Quality of Life measured by Spitzer Index (Spitzer 1981), Correlaton of ACTS and Spitzer Index
Rate of clinically relevant bleeding (major + clinically relevant non major) within 12 weeks
Rate of minor bleedings within 3 months

Rate der symptomatischen VTE-Rezidive innerhalb von 12 Wochen
Explorative Analyse der Patienten mit Behandlung »on protocol« (Komplette Behandlungsdauer über 12 Wochen)
Explorative Analyse der Patienten mit Behandlung »time on treat-ment«
Subgruppenanalysen in Hinblick auf Lungenarterienembolie (LAE), VTE Rezidiv und Blutungen (Schwere [Major] Blutungen, klinische Relevanz, leichte [Minor] Blutungen) in Abhängigkeit von den Stratifizierungsmerkmalen
Rate an Herzinfarkten
Rate an ischämischen Schlaganfällen
Compliance
Gesamtmortalität 3 und 6 Monate nach Randomisierung
Beurteilung der Lebensqualität gemessen mit Spitzer-Index und »Treatment Satisfaction Questionnaire for Medication« (TSQM II) (Spitzer u. a. 1981), Korrelation von ACTS ,Spitzer-Index und TSQM II über 12 Wochen
Rate an klinisch relevanten Blutungen innerhalb von 12 Wochen
Rate an Minor Blutungen innerhalb von 12 Wochen

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Newly diagnosed and objectively confirmed acute venous thrombo-embolism
Active malignancy
Life expectancy of at least 6 months
Performance-Status according to Karnofsky Performance Scale ≥ 70 %
Patient’s compliance and geographical situation allowing an adequate follow up
platelets ≥ 100.000 /μl, INR < 1.5, PTT < 40 sec.
written informed consent of the patient prior to any procedure in connection with the study
male and female patients with an age of at least 18 years

Neu diagnostizierte und objektiv bestätigte akute venöse Thrombose oder Thrombembolie
Aktive, prinzipiell behandlungspflichtige Tumorerkrankung mit oder ohne kausale Therapie
Lebenserwartung von mindesten 6 Monaten
Leistungsfähigkeit / Performance Status > 70% analog zu Karnofsky Perfomance Scale oder Eastern Coopertive Oncology Group perfor-mance status (ECOG) 0–1
Patientencompliance und wohnortnähe, lassen eine adäquate Nachbeobachtung zu
Thrombozytenzahl ≥ 100.000/µl, INR < 1,5, aPTT < 40s
Unterschriebene Einwilligungserklärung des Patienten vor irgendei-ner Maßnahme im Zusammenhang mit der Studie
Frauen und Männer mit einem Mindestalter von 18 Jahren

E.4

Principal exclusion criteria

therapeutic anticoagulation > 96 hours prior to study treatment
known allergic reactions against the study drugs or the substances included therein
known conditions associated with high risk of bleeding, known history of hemorrhagic diathesis
acute clinically relevant bleeding in the last 2 weeks
any history of spontaneous major/cerebral bleeding
history of HIT II
pregnant or breast-feeding women. Women of child-bearing potential must have a negative pregnancy test performed < 7 days prior to start of the treatment
severe renal insufficiency (GFR < 30 ml/min)
liver disease with coagulation impairment, including Child B and C cirrhosis
acute medical illness
treatment of the underlying cancer with experimental therapies (in Germany not approved)

Therapeutische Antikoagulation > 96 Stunden vor Studienbehand-lung/ Einschluss
Bekannte allergische Reaktionen auf die Studienmedikation oder Substanzen, die in der Studienmedikation enthalten sind
Bekanntes hohes Blutungsrisiko, vorbekannte Episode einer hämorr-hagische Diathese
Akute klinisch relevante Blutung in den letzten zwei Wochen
Episode(n) einer spontanen schweren oder intracerebralen Blutung
HIT II in der Anamnese
Schwangere oder stillende Frauen. Frauen im gebährfähigem Alter müssen eine negativen Schwangerschaftstest aufweisen (nicht älter als 7 Tage).
Mittelschwere bis schwere Niereninsuffiezienz (GFR < 30ml/min)
Leberinsuffizienz mit Gerinnungsstörungen, inklusive Leberzirrhose Child B und C
unkontrollierte schwere Begleiterkrankungen)
Behandlung der Krebserkrankung mit experimentellen Therapien/Medikamenten (die in Deutschland nicht zugelassen sind.)

E.5 End points

E.5.1

Primary end point(s)

Patient’s treatment satisfaction (convenience) measured with the anti-clot treatment scale (ACTS Burden)

Zufriedenheit der Patienten mit der Behandlung (Convenience)
gemessen mit »Anticlot Treatment Scale« (ACTS Burden)

E.5.1.1

Timepoint(s) of evaluation of this end point

4 , 8, 12 weeks after start of treatment

4, 8, 12 Wochen nach Therapiebeginn

E.5.2

Secondary end point(s)

Rate of symptomatic VTE-recurrence within 12 weeks
exploratory analysis for patients with treatment “on protocol” (complete treatment exposure for 12 weeks)
exploratory analysis for “time on treatment” (endpoints in relation to time on-study-drug)
Subgroup analysis with regard to Pulmonary embolism (PE,) VTE recurrence and bleedings (major, clinically relevant, minor) according to stratification characteristics
Rate of myocardial infarction
Rate of ischemic stroke
Compliance
Overall mortality 3 and 6 months after randomization
Quality of Life measured by Spitzer Index (Spitzer 1981), Correlaton of ACTS and Spitzer Index
Rate of clinically relevant bleeding (major + clinically relevant non major) within 12 weeks
Rate of minor bleedings within 12 weeks

Rate der symptomatischen VTE-Rezidive innerhalb von 12 Wochen
Explorative Analyse der Patienten mit Behandlung »on protocol« (Komplette Behandlungsdauer über 12 Wochen)
Explorative Analyse der Patienten mit Behandlung »time on treat-ment« (Endpunkte im Verhältnis zur time-to-study-drug)
Subgruppenanalysen in Hinblick auf Lungenarterienembolie (LAE), VTE Rezidiv und Blutungen (Schwere [Major] Blutungen, klinische Relevanz, leichte [Minor] Blutungen) übereinstimmend zu den Strati-fizierungsmerkmalen
Rate an Herzinfarkten
Rate an ischämischen Schlaganfällen
Compliance
Gesamtmortalität 3 und 6 Monate nach Randomisierung
Beurteilung der Lebensqualität gemessen mit Spitzer-Index und »Treatment Satisfaction Questionnaire for Medication« (TSQM II) (Spitzer u. a. 1981), Korrelation von ACTS ,Spitzer-Index und TSQM II über 12 Wochen
Rate an klinisch relevanten Blutungskomplikation (schwerwiegende + klinisch relevante nicht schwerwiegende) innerhalb von 12 Wochen
Rate an Minor-Blutungen innerhalb der letzten 12 Wochen

E.5.2.1

Timepoint(s) of evaluation of this end point

4 , 8, 12 weeks after start of treatment

4, 8, 12 Wochen nach Therapiebeginn

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

convenience, Quality of life

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

250

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

200

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

450

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

keine

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-01-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-10-26

P. End of Trial
P.	End of Trial Status	Temporarily Halted

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