Clinical Trials Register

Summary
EudraCT Number:	2010-019587-36
Sponsor's Protocol Code Number:	DSHNHL2009-1
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2011-04-19
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

2010-019587-36

A.3

Full title of the trial

Improvement of outcome and reduction of toxicity in elderly patients with CD20+ aggressive B-cell lymphoma by an optimised schedule of the monoclonal antibody rituximab, substitution of conventional by liposomal vincristine and FDG-PET based reduction of therapy in combination with vitamin D substitution

A.3.1

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

Improvement of outcome and reduction of toxicity in elderly patients with
CD20+ aggressive B-cell lymphoma by an optimised schedule of the
monoclonal antibody rituximab, substitution of conventional by another
vincristine and FDG-PET based reduction of therapy in combination with
vitamin D substitution

A.3.2

Name or abbreviated title of the trial where available

OPTIMAL>60/DR.CHOP

A.4.1

Sponsor's protocol code number

DSHNHL2009-1

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01478542

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	Universität des Saarlandes
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	Acrotech Biopharma LLC
B.4.2	Country	United States
B.4.1	Name of organisation providing support	F. Hofmann la Roche Ltd.
B.4.2	Country	Germany
B.4.1	Name of organisation providing support	Amgen 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	Universität des Saarlandes
B.5.2	Functional name of contact point	Central Study Office
B.5.3	Address:
B.5.3.1	Street Address	Klinik für Innere Medizin I
B.5.3.2	Town/ city	Homburg (Saar)
B.5.3.3	Post code	66421
B.5.3.4	Country	Germany
B.5.4	Telephone number	+4968411615014
B.5.5	Fax number	+4968411615015
B.5.6	E-mail	dshnhl@uks.eu

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	Marqibo
D.3.2	Product code	L01CA02
D.3.4	Pharmaceutical form	Dispersion for infusion
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.3.8	INN - Proposed INN	vincristine sulphate
D.3.9.1	CAS number	N/A
D.3.9.3	Other descriptive name	vincristine sulphate, liposomes
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.3	Concentration number	0,16
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	Yes
D.3.11.13.1	Other medicinal product type	cytostatic drug
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	Mabthera 100 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Mabthera 100 mg
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
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.3.8	INN - Proposed INN	Rituximab
D.3.9.1	CAS number	17472231
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
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	No
D.3.11.9	Recombinant medicinal product	Yes
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	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	Mabthera 500 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Rituximab (MabThera) 500 mg
D.3.2	Product code	45-2294
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
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.3.8	INN - Proposed INN	Rituximab
D.3.9.1	CAS number	17472231
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
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	No
D.3.11.9	Recombinant medicinal product	Yes
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.2.5	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	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.3.8	INN - Proposed INN	VINCRISTINE SULFATE
D.3.9.1	CAS number	2068-78-2
D.3.9.4	EV Substance Code	SUB05101MIG
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	Yes
D.3.11.13.1	Other medicinal product type	cytostatic drug

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

Diffuse large B-cell lymphoma

Diffus-großzelliges B-Zell-Lymphom

E.1.1.1

Medical condition in easily understood language

aggressive B-Cell Non-Hodgkin's Lymphoma

aggressives Non-Hodgkin Lymphom vom B-Zell Typ

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	SOC
E.1.2	Classification code	10005329
E.1.2	Term	Blood and lymphatic system disorders
E.1.2	System Organ Class	10005329 - Blood and lymphatic 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

Patients with less favourable prognosis:
1:To test whether progression-free survival (PFS) can be improved by substituting conventional by liposomal vincristine;
2:To test whether PFS can be improved by 12 optimised applications instead of 8 2-week applications of rituximab
Patients with favourable pro¬gnosis:
3:Comparison of neurotoxicity of conventional and liposomal vincristine;
4:Determination of PFS for the treatment strategy of reducing treatment in patients with negative FDG-PET after 4 x R-CHOP/CHLIP-14 (PET-4) and comparison with the corresponding patient population in RICOVER-60.

bei Patienten mit weniger günstiger Prognose:1.Kann das progressionsfreie Überleben (PFS) durch Ersatz des konv.Vincristins (VCR) in der CHOP-Chemotherapie (CTX) durch lip.VCR verbessert werden? 2.lässt sich das PFS durch 12 optimierte Gaben des Antikörpers Rituximab (R) anstelle von 8 Gaben im Abstand von 2 Wochen in Kombination mit CHOP-14 oder CHLIP-14 CTX verbessern? b)bei Patienten mit günstiger Prognose:3.Vergleich der Neurotoxizität von konventionellem und liposomalem VCR 4.Bestimmung des PFS unter Reduktion der Therapie im Falle eines negativen FDG-PETnach 4x R-CHOP/CHLIP-14 und Vergleich mit der entsprechenden Patientenpopulation in RICOVER-60

E.2.2

Secondary objectives of the trial

all
-progn val of pre-treatm PET with conv CT/MRT
-progn val of diff PET derived imaging biomarkers
-PET-based indivi treatm strategy in OPTIMAL>60 with fixed treatm strategy in RICOVER>60
-VCR-rel neurotox (Less Fav)&other tox (all)
-therap efficacy vit D subst by comparing the first pat w/o vit D subst with pat with vit D subst
-VCR rel neurotox &CNS events before/after A#4
- Comp Cheson, Lugano&RECIL resp crit
-Role of (M)TV
-progn value of pre- & post-prephase treatm ECOG, of ref path and plasma biomarkers
Fav pat:
Determ, if adding 2xChemo+inv-node RX can compensate for assumed worse progn of pat with pos PET after 4xR-Chemo compared to pat with neg PET after 4xR-Chemo. Comp of PET pos pat who receive 2additional R-Chemo+RX with those who do not.
Less Fav:
Determ whether assumed worse progn of pat with bulk PET-pos after CTX compared to pat with PET-neg bulk after CTX can be compensated by RX to PET-pos bulk. Comp of pat with pos PET with/without RX

alle: Vergl progn Wert prätherap PET mit konv CT/MRT
-progn Wert. versch. PET abgeleiteter Biomarker
-Vergl.PET-bas indiv Therapiestrat OPTIMAL-Studie mit fixer Therapiestrat RICOVER-60
-VCR-ass Tox (Less Fav) u. sonst. Tox (alle)
-therap Stellenwert VitD-Substit durch Vergl Pat ohne/mit VitD-Subst
-VCR-ass. Tox, CNS-Events vor/nach A#4
-Cheson-, Lugano-& Recil-Resp Krit
-Rolle (M)TV
-progn Wert ECOG vor/nach Vorphase, refpath Biomarker, ctDNA
Fav: Prüfung, ob 2 zus Chemozyklen + inv-node RX die angenommene schlechtere Progn der Pat mit nach 4xR-Chemo pos PET im Vergl zur Progn von Pat mit neg PET kompensieren können. Vergl PET pos Pat, die zusätzlich 2x R-Chemo+RX erhalten mit PET pos Pat, die diese zusätzliche Therapie nicht erhalten
Less Fav: Prüf ob RX die angenommene schlechtere Progn der Pat mit nach CTX PET-pos Bulk im Vergl zu Pat mit PET-neg Bulk kompensieren kann sowie Vergl Therapieergebnisse Pat mit posttherap pos PET, die eine/keine Strahlentherapie erhalten

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Cf. chapter 17 of the protocol:
1)Special investigations: rituximab and vincristine pharmacokinetics
Another goal of this study is the acquisition of pharmacokinetic data of the different rituximab application schedules as well as of vincristine.
Therefore, rituximab pharmacokinetic data will be obtained from 20 male and 20 female patients with less favourable patients treated with bi-weekly and optimised rituximab, respectively (i. e. 80 patients in total), irrespective of the type of vincristine given.
In addition, pharmacokinetic data of conventional and liposomal vincristine will be obtained in 5 male and 5 female patients with less favourable prognosis treated with conventional and liposomal vincristine, respectively in each of the 4 protocol arms (i.e. in 40 patients in total). ). The samples for pharmacokinetic data will be obtained 10 minutes before and 10 minutes after the end of the application of vincristine in cycle 1 . One additional sample will be obtained 12-24 hours after the application of vincristine in cycle 1 . At cycle 6 one sample will be taken 10 minutes before start of vincristine infusion. Even in case of any discontinuation of vincristine/Marqibo one serum sample should be taken before the application of chemotherapy in cycle 6. The schedule for the pharmacokinetic sampling must be strictly adhered to.
These analyses will not be performed in patients receiving HD-MTX.
Any pharmacokinetic studies will only be performed in centres with the necessary infrastructure after obtaining written informed consent from the patients.

2) Circulating lymphoma-derived DNA
Another goal of this study is the determinaton of circulating lymphoma derived DNA (ctDNA) in the blood of the patients randomised after Amendment #4. This “liquid biopsy” will be taken together with the necessary blood tests before each cycle of CHOP/CHLIP, at restaging after completion of therapy, and at each follow-up during the first two years after the end of treatment.
Any “liquid biopsy” will only be performed in patients after obtaining a seperate written informed consent.

E.3

Principal inclusion criteria

Elderly patients (61-80 years) with newly diagnosed aggressive CD20+ B-NHL. All risk groups with good general condition (ECOG 0-2) without majour accompanying diseases after patient's information and written patient's informed consent

Patienten im Alter von 61 bis 80 Jahren mit neu diagnostiziertem CD20-positivem aggressivem Lymphom aller Risikogruppen in gutem Allgemeinzustand (ECOG 0-2) ohne wesentliche Begleiterkrankungen nach Aufklärung und schriftlicher Einverständniserklärung

E.4

Principal exclusion criteria

Already initiated lymphoma therapy ; Serious accompanying disorder or impaired organ function; Platelets <75 000/mm3, leukocytes <2 500/mm3; Known hypersensitivity to the medications to be used; Known HIV-positivity; Chronic active hepatitis; Poor patient compliance; Simultaneous participation in other treatment studies or in another clinical trial; Prior chemo- or radiotherapy, long-term use of corticosteroids or anti-neoplastic drugs for previous disorder; CNS involvement of lymphoma; Persistent neuropathy grade ≥2 (unless due to lymphoma involvement) ;Pregnancy or breast-feeding women Persons depending on sponsor or investigator
Persons from highly protected groups.

Bereits begonnenen Behandlung des Lymphoms, schwerwiegende Begleiterkrankung; Thrombozyten <75 000/mm3, Leukozyten <2500/mm3, bekannte Allergie gegen eingesetzte Medikament, bekannte HIV-Positivität, chronisch aktive Hepatitis, schlechte Patienten-Compliance, gleichzeitige Teilnahme an anderen klinischen Prüfungen, frühere Chemo- oder Radiotherapie oder Langzeitgebrauch von Corticosteroiden oder Zytostatika bei früheren Erkrankungen, ZNS-Beteiligung des Lymphoms, Polyneuropathie Grad ≥2 (außer lymphomassoziiert), Schwangerschaft oder Stillzeit, vom Sponsor oder Prüfarzt abhängige Personen; sonstige unter besonderem Schutz stehende Personen

E.5 End points

E.5.1

Primary end point(s)

Progression free survival.
PFS is defined by the time between the day of randomisation until one of the following events occurs, whichever comes first:
-Disease progression (PD)
-Relapse after achieving CR
-Progression after PR, NC or unknown
-Death due to any cause.
Patients who have not experienced an event at the time of analysis will be censored at the most recent date of disease assessment

E.5.1.1

Timepoint(s) of evaluation of this end point

during the restagings and the follow-up assessments as planned in the protocol (cf. chapter 8.11 of the protocol).

E.5.2

Secondary end point(s)

for efficacy: rate of complete remissions (CR rate), rate of partial responses (PR rate), rate of primary progressions, relapse rate, event-free survival (EFS) and overall survival (OS); rate and CTC grades of polyneuropathy.
Prognostic value of the FDG-PET derived imaging biomarkers for lymphoma load: SUV (standardized uptake value), SUR (standardized uptake ratio), metabolic tumor volume (MTV), total lesion glycolysis (TLG), SUR-derived TLG (TLGSUR).
Different reference pathology biomarkers from tumor tissue and circulating tumor DNA in the plasma

E.5.2.1

Timepoint(s) of evaluation of this end point

for efficacy and FDG-PET derived Imaging biomarkers: during the restagings and the follow-up assessments as planned in the protocol (cf. chapter 8.11 of the protocol). The incidence and rates of polyneuropathy will additionally be assessed before each cycle of chemotherapy. Assessment of ctDNA: before each cycle of CHOP/CHLIP, at restaging after completion of therapy, and at each follow-up during the first two years after the end of treatment.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

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

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)

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

Yes

E.8.2.3.1

Comparator description

Vergleichspräparat für Marqibo (liposomales Vincristin) ist konventionelles Vincristin

Comparator fo Marqibo (liposomal vincristine) is conventional vincristine

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

130

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

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

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	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.1.3.1	Number of subjects for this age range:	1152
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	No
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	No
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	1152

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

2011-10-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-06-16

P. End of Trial
P.	End of Trial Status	Ongoing

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