Clinical Trials Register

Summary
EudraCT Number:	2012-000066-37
Sponsor's Protocol Code Number:	NM-V-101
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-07-02
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

Germany - BfArM

A.2

EudraCT number

2012-000066-37

A.3

Full title of the trial

Double-blind, randomized, placebo-controlled study on efficacy, safety and tolerability of ancrod in patients with sudden sensorineural hearing loss

Doppelblinde, randomisierte, plazebokontrollierte Studie zur Wirksamkeit, Sicherheit und Verträglichkeit von Ancrod bei Patienten mit plötzlichem sensorineuralem Hörverlust (Hörsturz).

A.3.1

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

Efficacy, safety, and tolerability of Ancrod in patients with sudden hearing loss

Wirksamkeit, Sicherheit und Veträglichkeit von Ancrod bei Hörsturzpatienten

A.3.2

Name or abbreviated title of the trial where available

n.a.

A.4.1

Sponsor's protocol code number

NM-V-101

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01621256

A.5.4

Other Identifiers

Name:

NM-V-101

Number:

n.a.

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	Nordmark Arzneimittel GmbH & Co. KG
B.1.3.4	Country	Germany
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	Nordmark Arzneimittel GmbH & Co
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	Nordmark Arzneimittel GmbH & Co. KG
B.5.2	Functional name of contact point	Clinical Development
B.5.3	Address:
B.5.3.1	Street Address	Pinnauallee 4
B.5.3.2	Town/ city	Uetersen
B.5.3.3	Post code	25436
B.5.3.4	Country	Germany
B.5.4	Telephone number	494122712667
B.5.5	Fax number	494122712740
B.5.6	E-mail	maike.mellulis@nordmark-pharma.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	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.3.1	Product name	Ancrod (Viprinex TM)
D.3.2	Product code	NM-V
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ANCROD
D.3.9.1	CAS number	9046-56-4
D.3.9.2	Current sponsor code	Venotrombin A
D.3.9.3	Other descriptive name	Agkistrodon serine protease
D.3.9.4	EV Substance Code	SUB00525MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU/ml international unit(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	70
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	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

sudden sensorineural hearing loss (SSHL)

Plötzlicher unilateraler Hörverlust

E.1.1.1

Medical condition in easily understood language

hearing loss

Hörsturz

E.1.1.2

Therapeutic area

Diseases [C] - Ear, nose and throat diseases [C09]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10040016
E.1.2	Term	Sensorineural hearing loss
E.1.2	System Organ Class	100000004854

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of this study is to determine the efficacy of ancrod as primary treatment of SSHL compared to placebo in patients with unilateral sudden sensorineural hearing loss as determined by audiometry

Primäres Ziel:
Bestimmung der Wirksamkeit von Ancrod im Vergleich zu Placebo als primäre Behandlung des plötzlichen, unilateralen sensorineuralen Hörsturzes bestimmt anhand der Audiometrie

E.2.2

Secondary objectives of the trial

The secondary objectives of this study are to evaluate:
- The relationship between biomarkers and clinical efficacy.
- The safety and tolerability of ancrod.

Sekundäre Ziele der Studie sind:
- Die Bestimmung der Beziehung zwischen Biomarkern und klinischer Wirksamkeit .
- Bestimmung von Sicherheit und Verträglichkeit von Ancrod

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients must meet all of the following inclusion criteria in order to be eligible for this study:
1. Unilateral idiopathic sudden sensorineural hearing loss ≥30 dB in at least 2 consecutive frequencies in the affected ear or ≥20 dB in 3 consecutive frequencies based upon evaluation of 8 frequencies, 0.125, 0.25, 0.5, 1, 2, 4, 6, and 8 kHz, compared to the contralateral ear.
2. Symmetric hearing prior to onset of SSHL, according to patient’s recollection.
3. Patients with hearing loss not greater than 90dB at 0.125, 0.25, 0.5, 1, 2, 4, 6, and 8 kHz.
4. Enrollment has to be accomplished within 7 days after SSHL onset.
5. Male or female aged ≥18 to ≤70 years.
6. Women of childbearing potential who are sexually active with opposite partners have to perform adequate contraception with a combination of a highly effective method of birth control and additional barrier contraception.
[Highly effective method of birth control is defined as those, alone or in combination, that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly for the entire study duration: combined (oestrogen and gestagen) oral contraceptives, hormone implants, hormone injectables, or hormone containing intrauterine device that needed to be in place for a period of at least 2 months prior to screening. Additional barrier contraception (at least the following methods are allowed: condom of the male, diaphragm with spermicide, portio cap with spermicide) has to be used for the duration of the trial, defined as from the time of screening to at least 10 days after day 6 (Visit 4). A single barrier method is not acceptable. Women of non-childbearing potential can be included if surgically sterile (documented complete hysterectomy or bi-tubal ligations) or post-menopausal >1 year.]
7. Men of reproductive potential must use condoms. In addition, the female partner should also be on a safe hormonal contraception (e.g. combined oral contraceptives, hormone implants, hormone injectables or hormone containing intrauterine device) or use a barrier contraception (e.g. intrauterine device, diaphragm or portio cap with spermicide), if she is of childbearing potential.
8. Ability to understand and to follow the study protocol.

1. Unilateraler, idiopathischer Hörsturz mit einem Hörverlust von ≥30 dB in zwei benachbarten Frequenzen oder ≥20 dB in 3 benachbarten Frequenzen im Frequenzbereich von 0.125-8 kHz, im Vergleich zum kontralateralen Ohr.
2. Symmetrisches Hörvermögen vor dem Hörsturz
3. Patienten mit einem Häöärverlust nicht größer als 90dB bei 0.125, 0.25, 0.5, 1, 2, 4, 6 und 8 kHz.
4. Aufnahme in die Studie innerhalb von 7 Tagen nach Beginn des Hörsturzes
5. Frauen oder Männer im Alter von 18 bis 70 Jahre
6. Sexuell aktive Frauen im fortpflanzungsfähigen Alter müssen adäquate Methoden zur Kontrazeption bestehend aus einer Kombination einer hockeffektiven Empfängnisverhütungsmethode zusammen mit einer Barrieremethode durchführen. Hocheffektive Methoden der Geburtenkontrolle sind definiert als solche– alleine oder in Kombination - , die eine Versagen von unter 1 % pro Jahr aufweisen, sofern sie über die gesamte Studiendauer verwendet werden: Kombinierte (Gestagen und Östrogen) orale Kontrazeptiva, Hormonimplantate, injizierbare Hormone oder hormonhaltige intrauterine Medizinprodukte, die mind. 2 Monate vor der Screeningvisite implantiert worden sind. Zusätzliche Barrieremethoden, die während der gesamten Studiendauer (vom Screening bis mind. 10 Tage nach Tag 6(Visite 4) verwendet werden müssen, sind: Kondome für Männer, Diaphragma oder Portiokappe mit Spermizid. Eine Barrieremethode alleine ist nicht akzeptabel. Frauen, die nicht gebärfähig sind, können eingeschlossen werden, sofern sie operativ sterilisiert (dokumentierte komplette Hysterektomie oder Ligation beider Eileiter) oder seit >1 Jahr postmenopausal sind.
7. Männer im reproduktionfähigen Alter müssen Kondome verwenden. Zusätzlich müssen die Partnerinnen im gebährfähigen Alter eine sichere hormonelle Kontrazeptionsmethode verwenden (z.B kombinierte orale Kontrazptiva, Hormonimplante, injezierbare Hormonpräparate, oder hormonhaltige intrauterine Medizinprodukte) oder eine weitere Barrieremethode verwenden (z.B. intrauterine Medizinprodukte Diaphragma, oder Portiopkappe mit Spermizid

8. Fähigkeit das Protokoll zu verstehen und den Anordnungen des Studienleiters zu folgen

E.4

Principal exclusion criteria

1. Pregnant or breast-feeding female.
2. positive pregnancy test before receiving study drug
3. Body weight >140 kg.
4. Bilateral SSHL.
5. Incomplete recovery after previous SSHL, when symetric hearing loss was not reached again, according to patient´s recollection
6. Due to history of physical efforts suspected perilymph fistula or membrane rupture.
7. Previously existing, known retrocochlear hearing loss.
8. Any history of any ear operation or local inflammatory disease in the past one year
9. History of blunt or penetrating ear trauma, head trauma, barotrauma, or acoustic trauma immediately preceding SSHL.
10. History of Menière’s disease, autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops.
11. Any pre-treatment within the preceding 30 days prior to screening, ongoing treatment or planned treatment of SSHL-related hearing loss.
12. History of chronic inflammatory diseases or autoimmune diseases e.g. rheumatic disease, including rheumatoid arthritis, scleroderma, lupus erythematosus, polymyalgia rheumatica, polyarteritis nodosa, temporal/giant cell arteritis, Sjögren’s syndrome, or ulcerative colitis and Crohn’s disease.
13. History of unstable angina, coronary artery stenting or bypass grafting within three months of enrolment, transient ischemic attacks or stroke within four weeks of enrolment.
14. Prior chemotherapy or treatment with immunosuppressant drugs (azathioprine, chlorambucil, cyclophosphamide, or other alkylating agents), cyclosporine, etanercept, infliximab, interferon or any therapy with drugs known as ototoxic (e.g. aminoglycosides, cisplatin, loop diuretics, quinine etc.) in the past 6 months.
15. Gastrointestinal pathology: lesions liable to bleed such as active peptic ulcer disease, inflammatory bowel disease, history of gastrointestinal bleeding, or recent hemorrhage at any anatomical site requiring medical intervention.
16. Screening plasma fibrinogen level of <180 mg/dL.
17. Known disorder of platelet function or coagulation abnormality.
18. Platelet count of <100,000/mm3.
19. Severe liver disease.
20. Hepatic failure (e.g., aspartate aminotransferase (SGOT) or alanine aminotransferase (SGPT) ≥3 × upper limit of normal [ULN])
21. Treatment with hyperbaric oxygen within one week prior to study drug.
22. Renal insufficiency (e.g., blood urea nitrogen or creatinine ≥2 × ULN) or patients on renal dialysis.
23. Use of another investigational drug within 30 days prior to SSHL onset.
24. Any other serious medical condition that might interfere with subject evaluation over the 90-day study period, based on the investigator’s judgment, e.g. planned surgical intervention or any other condition which might give doubt for non-completing the study e.g. planned holiday, distance between investigational center and place of origin.
25. Known hypersensitivity to the drug substance or excipients.
26. Blood or blood product infusion within one week prior to study drug.
27. Use of any prohibited drug listed in chapter 6.4.1 and 6.4.2 of this study protocol.
28. Immunoglobulin infusion 4 weeks prior to study drug.
29. Planned treatment using intramuscular injections (e.g. vaccinations, vitamin B therapy)
30. Conditions associated with an increased risk of hemorrhaging such as major surgery, history of hemorrhagic stroke, intracranial hematoma, subarachnoid hemorrhage, diabetic retinopathy, retinopathy grade 3 or worse, known hemostatic disorders
31. Uremia and renal colic with calculus, cerebrovascular accident, and history of neurosurgery
32. History of malignant hypertension and/or diastolic pressure > 105 mmHg
33. Acute pericarditis
34. Subacute bacterial endocarditis
35. Septicemic states with or without evidence of diffuse intravascular coagulation
36. History of clinically relevant immediate-type allergy (type I) with respect to e.g. mildew, (house dust) mite, cockroach, hymenoptera venom, dog, cow and honeydew melon
37. Hearing loss of infectious or oncology origin

1. Schwangere oder stillende Mütter
2. postiver Schwangerschaftstest vor Einnahme der Studienmedikation
3. Körpergewicht > 140 kg
4. Bilateraler Hörsturz
5. Unvollständige Wiederherstellung des Hörvermögens nach vorhergehendem Hörsturz, wenn das symetrische Hörvermögen nach Einschätzung des Patienten nicht wieder erreicht wurde
6. Durch körperliche Anstrengung verursachte Perilymph-Fistel oder Membranruptur
7. Vorbestehender, bekannter retrocochlearer Hörverlust
8. Vorgeschichte jeglicher Ohroperation oder lokaler Entzündungen im vergangenen Jahr
9. Vorgeschichte eines stumpfen oder penetrierenden Ohrtraumas, Kopftraumas, Barotraumas oder eines akustischen Traumas unmittelbar vor dem Hörsturz
10. Vorgeschichte von Menière'scher Krankheit, Hörverlust aufgrund einer Autoimmunerkrankung, strahlungsbedingter Hörverlust oder endolymphatischer Hydrops
11. Jegliche Vorbehandlung innerhalb der letzten 30 Tage vor dem Screening, fortlaufende Behandlung oder geplante Behandlung des Hörsturzes.
12. Vorgeschichte chronisch entzündlicher oder Autoimmunerkrankungen, wie z.B. rheumatoide Arthritis, Sklerodermie, Lupus erythematodes, Polymyalgia rheumatica, Polyarteritis nodosa, Riesenzellarteriitis, Sjögren’s Syndrom, oder ulcerative Colitis
13. Vorgeschichte von instabiler Angina pectoris, koronare Stent- oder Bypass-Operation innerhalb der letzten 3 Monate, transiente ischämische Attacke oder Schlaganfall vier Wochen vor Aufnahme in die Studie
14. Vorhergehende Chemotherapie oder Behandlung mit Immunsuppressiva (Azothioprine, Chlorambucil, Cyclophosphamide oder andere alkylierende Substanzen), Cyclosporin, Etanercept, Infliximab, Interferon oder Substanzen mit ototoxischem Potential (Aminoglycoside, Cisplatin, Schleifendiuretika, Chinin, etc.) in den letzten 6 Monaten
15. Gastrointestinale Pathologie: Läsionen, die ursächlich für Blutungen sind: Aktiver Magenulcus, chronisch entzündliche Darmerkrankungen, Vorgeschichte von gastrointestinalen Blutungen oder anderen behandlungsbedürftigen Blutungen
16. Plasma Fibrinogenkonzentration bei der Screeninguntersuchung < 180 mg/dl
17. Thrombozytenfunktionsstörung oder Gerinnungsanomalien
18. Thrombozytenzahl < 100,000/mm3
19. Schwere Lebererkrankungen
20. Leberversagen (SGOT, SGPT ≥ 3 × oberer Normwert)
21. Behandlung mit hyperbarem Sauerstoff eine Woche vor Applikation der Studienmedikation
22. Niereninsuffizienz (Kreatinin ≥ 2 × oberer Normwert) oder Dialysepflicht
23. Einnahme einer anderen Studienmedikation innerhalb der letzten 30 Tage vor Beginn des Hörsturzes
24. Jede andere ernsthafte Erkrankung, die sich nach Einschätzung des Studienarztes auf die Untersuchung des Patienten in der 90 Tage dauernden Studienperiode auswirken könnten, wie z.B. eine geplante Operation, aber auch andere Einschränkungen wie z.B. geplanter Urlaub oder die Entfernung zum behandelnden Studienzentrum, die eine vollständige Teilnahme an der Studie zweifelhaft machen
25. Überempfindlichkeit gegen die Prüfsubstanz oder die verwendeten Hilfsstoffe
26. Transfusion von Blut oder Blutprodukten eine Woche vor Applikation der Studienmedikation
27. Verwendung nicht erlaubter Medikamente und Behandlungen (Kapitel 6.4.1 und 6.4.2. im Studienprotokoll)
28. Immunoglobulin-Infusion 4 Wochen vor Applikation der Studienmedikation
29. Geplante Behandlung mit intramuskulären Injektionen (z.B. Impfungen, Vitamin B Therapie)
30. Alle Zustände, die ein erhöhtes Blutungsrisiko beinhalten: große Operationen, Vorgeschichte eines Schlaganfalls, intrakranielles Hämatom, SAB, diabetische Retinopathie, Retinopathy Grad 3 oder schlechter, bekannte hämostatische Erkrankungen
31. Urämie und Nierenkoliken mit Steinen, zerebrovaskuläre Vorfälle, Vorgeschichte neurochirurgischer Operationen.
32. Vorgeschichte maligner Hypertension und/ oder diastolischer Blutdruck von > 105 mmHg
33. Akute Perikarditis
34. Subakute bakterielle Perikarditis
35. Sepsis mit oder ohne Evidenz diffuser intravaskulärer Koagulation
36. Vorgeschichte klinisch relevanter allergischer Reaktion vom Soforttyp 1 z.B. Reaktion auf Schimmel, (Hausstaub-)Milben, Schaben, Insektengifte, Hunde, Kühe und Honigmelone.
37. Hörverlust infektiösen oder onkologischen Ursprunges

E.5 End points

E.5.1

Primary end point(s)

The primary outcome measure for this study is the change in pure tone audiogram (PTA) in the affected ear from screening until Day 8. The PTA will be calculated as the arithmetic mean of air conduction thresholds at the affected consecutive frequencies in the frequency range of 0.125 to 8 kHz. A non-affected frequency within two affected frequencies will be included.

Als Primävariablen wird die Veränderung des betroffenen Ohres von der Screeningmessung bis zum Tag 8 in der Tonaudiometrie (PTA) gemessen. Diese wird als arithmetisches Mittel der Hörschwellen für die betroffenen Frequenzen (0,125-8 kHz) berechnet. Nicht betroffene Frequenzen zwischen 2 betroffenen eingeschlossen.



E.5.1.1

Timepoint(s) of evaluation of this end point

Day 8

Tag 8

E.5.2

Secondary end point(s)

Secondary outcome measures will include:
- Change in word recognition score from screening to Day 8, Day 30 and Day 90.
- Change of audiogram in the affected ear from screening to Day 30 and Day 90.
- Change in fibrinogen concentration from screening to Day 2 and Day 8.
- Change in biomarkers from screening to Day 8.
- Patient assessment of change in hearing impairment.
 Physician assessment of change in hearing impairment.
 Change in tinnitus severity.

Die Sekundärvariablen beinhalten die Messungen:
- Veränderung der Worterkennung vom Screening bis zum Tag 8, 30 und 90.
- Veränderungen des Audiogrammes (betroffenes Ohr) vom Screening bis zum Tag 30 und 90.
- Veränderung der Fibrinogenkonzentration vom Screening bis zum Tag, 2, 8, 30 und 90.
- Veränderungen der Biomarker vom Screening bis zum Tag 8.
- Die Veränderung der Hörverschlechterung in der Patientenbeurteilung
- Veränderung der Tinnitusschwere

E.5.2.1

Timepoint(s) of evaluation of this end point

Day 8 as well as 30 and 90

Tag 8 bzw 30 und 90

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

Yes

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

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

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

Letzter Teilnehmer . letzte visite

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

100

F.4.2.2

In the whole clinical trial

115

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 post study treatment should be done by the treating physician according to basic medical services. In case of premature study-drop out a final medical examination should be done in the study centre.

Der Patient soll im Rahmen der ärztlichen Grundversorgung nach Beendigung der Studie in Verantwortung des behandelnden Arztes weiter versorgt werden. Sollte der Patient frühzeitig aus der Studie ausscheiden, findet abschließend eine komplette Nachuntersuchung im Studienzentrum statt.

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

2012-12-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-01-16

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-09-14

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