Clinical Trials Register

Summary
EudraCT Number:	2011-005317-37
Sponsor's Protocol Code Number:	THR-2010-01
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-04-02
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

Austria - BASG

A.2

EudraCT number

2011-005317-37

A.3

Full title of the trial

Double blind, placebo controlled, escalating single-dose, pilot study to assess the safety of THR-18 when administered to patients suffering acute ischemic stroke and treated with tPA

A.3.1

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

Double blind, placebo controlled, escalating single-dose, pilot study to assess the safety of THR-18 when administered to patients suffering acute ischemic stroke and treated with tPA

A.4.1

Sponsor's protocol code number

THR-2010-01

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01253512

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	Thrombotech Ltd.
B.1.3.4	Country	Israel
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Thrombotech Technologies Ltd.
B.4.2	Country	Israel
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Thrombotech Ltd.
B.5.2	Functional name of contact point	Arnon Aharon
B.5.3	Address:
B.5.3.1	Street Address	5 Golda Meir St.
B.5.3.2	Town/ city	Ness Ziona
B.5.3.3	Post code	74036
B.5.3.4	Country	Israel
B.5.4	Telephone number	97208-9102920
B.5.5	Fax number	97208-9102867
B.5.6	E-mail	arnon@thrombotech.com

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	No
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.3.2	Product code	THR-18
D.3.4	Pharmaceutical form	Lyophilisate for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	THR-18
D.3.9.3	Other descriptive name	18 mer peptide
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Lyophilisate for solution for injection
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Acute ischemic stroke

E.1.1.1

Medical condition in easily understood language

Acute ischemic stroke

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10061256
E.1.2	Term	Ischaemic stroke
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Assess the safety of intravenous administration of two escalating doses (0.25 and 0.5 mg/kg, 150 ml) of THR-18 or placebo, infused as a 10% bolus over 2 minutes (15 ml) followed by a 60 min infusion of the remaining dose (135 ml), to acute ischemic stroke patients treated with tPA.

E.2.2

Secondary objectives of the trial

Assess the feasibility of evaluation of the efficacy parameters following intravenous administration of two escalating doses (0.25 and 0.5 mg/kg, 150 ml) of THR-18 or placebo, infused as a 10% bolus over 2 minutes (15 ml) followed by a 60 min infusion of the remaining dose (135 ml), to acute ischemic stroke patients treated with tPA.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Male or female.
2) Diagnosis of acute ischemic stroke onset less than 3 hours prior to the planned start of intravenous tPA (alteplase).
3) Have suffered an acute hemispheric ischemic stroke, defined as acute, focal, neurological deficit(s), secondary to a presumed vascular event, which must include at least one of the following:
• At least one of the following components (as reflected by at least 1 point on any of the corresponding items of the NIHSS: 9, 3 or 11):
o Language dysfunction (aphasic disorder, excluding dysarthria)
o Visual field defect (excluding monocular blindness)
o Extinction and Inattention (formerly Neglect)
Or
• An indication on routine diffusion-weighted magnetic resonance imaging (DW-MRI) or computed tomography perfusion scan at screening /baseline that the acute stroke involves the cerebral cortex
4) NIHSS larger > 5 and < 18 for left and right hemisphere strokes.
5) Age 18-85 years both inclusive.
6) Signed informed consent from patient or legally authorized representative or an independent witness or an independent physician, if applicable according to the Details about the consent procedure described in country-specific supplements to this protocol.
7) Subjects are indicated for the application of intravenous tPA (alteplase).

E.4

Principal exclusion criteria

2) Time interval since stroke onset of less than 3 hours is impossible to determine with high degree of confidence.
3) Symptoms suggestive of subarachnoid haemorrhage, even if CT or MRI scan is negative for haemorrhage.
7) Neurological deficit that has led to stupor or coma (NIHSS level of consciousness score greater than or equal to 2).
8) High clinical suspicion of septic embolus.
9) Minor stroke with non-disabling deficit or rapidly improving neurological symptoms in the absence of major vessel occlusion.
10) Baseline NIHSS greater than 18 for left and right hemisphere strokes.
11) Evidence of acute or chronic ICH by head CT or MRI.
14) Persistent hypertension with systolic BP greater than 185 mmHg or diastolic BP greater than 110 mmHg (mean of 3 consecutive arm cuff readings over 20-30 minutes), not controlled by antihypertensive therapy or requiring nitroprusside for control.
15) Blood glucose greater than 200 mg/dl.
18) Have suffered a stroke within 90 days of the screening/baseline assessments that is either diagnostically confirmed or assumed to be in the same cerebral territory as is the current acute stroke.
32) Subjects with disabling congestive heart failure (CHF) or unstable angina.
34) Subjects that suffered a myocardial infarction in the last 90 days.
47) Have a positive urine pregnancy test at screening/baseline or be a lactating female.
48) Any condition that in the investigator’s judgement precludes participation in the study.

E.5 End points

E.5.1

Primary end point(s)

The primary study variables will include the evaluation of the safety and elucidation of the PK profile of THR-18 in ischemic stroke subjects treated with tPA.

E.5.1.1

Timepoint(s) of evaluation of this end point

Throughout the whole study (safety parameters),
Day 1 (PK profile).

E.5.2

Secondary end point(s)

The secondary study variables include evaluation of the feasibility to use the efficacy parameters to detect an initial signal of efficacy.

E.5.2.1

Timepoint(s) of evaluation of this end point

96-120 hours post drug administration,
day 30,
month 3,
depending on the endpoint.

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

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

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)

E.8.2.2

Placebo

Yes

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

India

Israel

E.8.7

Trial has a data monitoring committee

Yes

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

Last visit of the last patient.

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

The further treatment and medical care of the trial subjects after the end of the clinical trial does not differ from the treatment of patients with the same indication according to appropriate clinical practice (see protocol section 8.5.1.5).

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

2012-05-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-04-27

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-07-17

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