Clinical Trials Register

Summary
EudraCT Number:	2015-000057-20
Sponsor's Protocol Code Number:	HC-G-H-1209
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2015-08-10
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

2015-000057-20

A.3

Full title of the trial

PROSPECTIVE, RANDOMIZED, CONTROLLED, DOUBLE-BLIND, MULTI-CENTRIC, INTERNATIONAL, STUDY ON THE EFFICACY AND SAFETY OF AN EARLY TARGET CONTROLLED PLASMA VOLUME REPLACEMENT THERAPY WITH A BALANCED GELATIN SOLUTION VS A BALANCED ELECTROLYTE SOLUTION IN PATIENTS WITH SEVERE SEPSIS / SEPTIC SHOCK

A.3.1

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

Controlled, international study conducted in several centres on the therapeutic effect and safety of an early controlled plasma volume replacement treatment with a balanced gelatin solution tested against a balanced salt solution in patients with severe septis / septic shock

A.3.2

Name or abbreviated title of the trial where available

GENIUS (GELATIN IN ICU AND SEPSIS)

A.4.1

Sponsor's protocol code number

HC-G-H-1209

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	B. Braun Melsungen AG
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	B. Braun Melsungen AG
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	Accovion GmbH
B.5.2	Functional name of contact point	Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	Helfmann-Park 10
B.5.3.2	Town/ city	Eschborn
B.5.3.3	Post code	65760
B.5.3.4	Country	Germany
B.5.4	Telephone number	+49619677090
B.5.5	Fax number	+4961967709117
B.5.6	E-mail	tduerrbaum@clinipace.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	Yes
D.2.1.1.1	Trade name	Gelafundin ISO 40 mg/ml Infusionslösung
D.2.1.1.2	Name of the Marketing Authorisation holder	B. Braun Melsungen 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.3.1	Product name	Gelaspan
D.3.4	Pharmaceutical form	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.3.9.1	CAS number	8000049276
D.3.9.3	Other descriptive name	SUCCINYLATED GELATIN
D.3.9.4	EV Substance Code	SUB22228
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40.0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	7647-14-5
D.3.9.3	Other descriptive name	SODIUM CHLORIDE
D.3.9.4	EV Substance Code	SUB12581MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5.55
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	6131904
D.3.9.3	Other descriptive name	SODIUM ACETATE TRIHYDRATE
D.3.9.4	EV Substance Code	SUB15266MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3.27
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	7447-40-7
D.3.9.3	Other descriptive name	POTASSIUM CHLORIDE
D.3.9.4	EV Substance Code	SUB12559MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	19935-04-8
D.3.9.3	Other descriptive name	CALCIUM CHLORIDE DIHYDRATE
D.3.9.4	EV Substance Code	SUB12664MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	0
D.3.9.3	Other descriptive name	MAGNESIUM CHLORIDE HEXAHYDRATE
D.3.9.4	EV Substance Code	SUB12526MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.20
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	Yes
D.3.11.13.1	Other medicinal product type	Isotonic colloidal volume substitute
D.IMP: 2
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	Sterofundin ISO Infusionslösung
D.2.1.1.2	Name of the Marketing Authorisation holder	B. Braun Melsungen 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.3.1	Product name	Sterofundin ISO
D.3.4	Pharmaceutical form	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.3.9.1	CAS number	7647-14-5
D.3.9.3	Other descriptive name	SODIUM CHLORIDE
D.3.9.4	EV Substance Code	SUB12581MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	6.80
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	6131904
D.3.9.3	Other descriptive name	SODIUM ACETATE TRIHYDRATE
D.3.9.4	EV Substance Code	SUB15266MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3.27
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	7447-40-7
D.3.9.3	Other descriptive name	POTASSIUM CHLORIDE
D.3.9.4	EV Substance Code	SUB12559MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	10035-04-8
D.3.9.3	Other descriptive name	CALCIUM CHLORIDE DIHYDRATE
D.3.9.4	EV Substance Code	SUB12664MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.37
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	0
D.3.9.3	Other descriptive name	MAGNESIUM CHLORIDE HEXAHYDRATE
D.3.9.4	EV Substance Code	SUB12526MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	6915-15-7
D.3.9.3	Other descriptive name	MALIC ACID
D.3.9.4	EV Substance Code	SUB14455MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.67
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

Hypovolaemia in Severe Sepsis / Septic Shock

E.1.1.1

Medical condition in easily understood language

Volume replacement in Severe Sepsis / Septic Shock

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.1
E.1.2	Level	PT
E.1.2	Classification code	10040070
E.1.2	Term	Septic shock
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10040047
E.1.2	Term	Sepsis
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Investigate the efficacy of early goal directed fluid management of a combination of a gelatin and crystalloid regime in comparison to a pure crystalloid regime in achieving haemodynamic stability (HDS) in patients with severe sepsis / septic shock.

E.2.2

Secondary objectives of the trial

Investigation of safety and efficacy parameters of the applied fluid regimes.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Male or female patients ≥ 18 years of age
• Women of child bearing potential must test negative on standard pregnancy test (urine or serum)
• Patients with body weight ≤ 140 kg
• Patients diagnosed severe sepsis / septic shock (refer to section 7.2.1 for definitions) at admission on ICU who can be enrolled within 90 min after admission OR patients diagnosed severe sepsis / septic shock during ICU stay who can be enrolled within 90 min after diagnosis
• Patients where antibiotic therapy has already been started (prior to randomization)
• Patients who are fluid responsive. Fluid responsiveness is defined as increase of > 10% in mean arterial pressure (MAP) after PLR or fluid challenge (max. 250 ml crystalloid solution)
• Signed informed consent by patient, legal representative or authorized person or deferred consent

E.4

Principal exclusion criteria

• Administration of HES, dextrane solutions or > 500 ml Gelatin solution within the 24 h prior to randomization
• Death expected within the next 48 h (moribund patients as defined by ASA ≥ class V)
• Patients with confirmed acute SARS-CoV-2 (COVID-19) infection (as available from routine medical records/ patient chart)
• Patients for whom the need of pressure infusions are expected
• Requirement for renal support (either continuous or discontinuous techniques, including intermittent haemodialysis, haemofiltration and haemodiafiltration)
• Patients receiving therapeutic heparin medication due to chronic coagulation disease / anticoagulation medication (i.e.partial thromboplastin time > 60 sec)
• Acutely burned patients:
Burns are defined as having any of the following before the administration of investigational products:
1. Burns > 10 % of body surface area classified as third or second-degree yet re-epithelialised
• Renal failure with oliguria or anuria
• Severe general oedema
• Severe congestive cardiac failure
• Hypersensitivity to the active substance or ingredients of the IPs
• Hypersensitivity to galactose-α-1,3-galactose (alpha-Gal) or known allergy to red meat (mammal meat) and offal
• Hypervolaemia / hyperhydration
• Hyperkalaemia
• Hypercalcaemia
• Metabolic alkalosis
• Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)

E.5 End points

E.5.1

Primary end point(s)

Time until first / initial HDS is achieved (in minutes).

E.5.1.1

Timepoint(s) of evaluation of this end point

Time measurement will start with first administration of IPs and will be continued until first HDS is achieved.

E.5.2

Secondary end point(s)

• Safety
-Renal function
Serum creatinine (SCr)
Serum blood urea nitrogen (BUN)
Estimated glomerular filtration rate (eGFR)
Need and indication of renal replacement therapy (RRT)
Urine output
Kidney Disease Improving Global Outcome (KDIGO) score
-Coagulation
Prothrombin time (PT)
Activated partial thromboplastin time (aPTT)
International norm ratio (INR)
-Hepatic function
Bilirubin
Adverse Events
(Serious) adverse events ((S)AEs) / reactions ((S)ARs)
-Other
Number of red blood cell (RBC) units
Number of fresh frozen plasma (FFP) units
Number of other blood products
Vasopressor therapy
Inotropic therapy
- Efficacy
Fluid administration according to the volume algorithm
Volume needed to achieve first / initial HDS
Total volume until 48 h after randomization
Administered bottles
Additional administered crystalloid solutions for further volume treatment
Drug and volume
Fluid balance
Fluid intake
Fluid output
Fluid balance
Haemodynamics
Volume responsiveness upon passive leg raising (PLR) or exogenous fluid challenge
Haemodynamic readings as required by the volume algorithm and haemodynamics from 48 h after randomization until ICU discharge or day 28, whatever occurs first
-Tissue oxygenation and acid base balance
Arterial blood gas analyses (BGA)
Serum electrolytes
Base excess (BE)
Lactate / lactate decrease
Central venous BGA
Arterial oxygen content
Oxygen delivery

• Outcome
Length of stay (LOS) in the intensive care unit (ICU)
Hospital LOS
Days on RRT
Number of infection free days
Number of antibiotic free days
Number of ventilator free days
Number of vasopressor free days
-Follow-up
Last available SCr (day 28)
Colloid therapy (day 28)
Mortality & cause of death (if applicable) (day 28 & day 90)
Health-related quality of life (HRQoL) (day 90)
New RRT / kidney disease (day 90)
-Other variables
Demographic data
Age
Gender
Height
Weight
Race
Type of patient (e.g. trauma patient, surgical patient)
Anamnesis
APACHE II & SOFA score
Temperature
Fluid input in the 24 h prior to randomization
Origin of sepsis
Procalcitonin (optional)
Causative organism of infection
Medical history
Concomitant medication
Antibiotic therapy
Nephrotoxic therapy
Contrast agents
Anticoagulation therapy
Study termination
Fibrinogen
Antithrombin
Platelets

Time points of evaluation:
At random.: Demographics, Anamnesis, Med. history; APACHE II,; At random. until day 7 (once daily): eGFR, KDIGO; From random. to 48 hrs after random. (cont.): Fluid admin. acc. algorithm, Vol. needed to achieve first / initial HDS, Total volume, Vol. responsiveness upon PLR /exog. fluid challenge, Haemodyn. ; At ICU/hospital discharge: LOS; At random. to ICU discharge/day 28 (once daily): Renal function, Coagulation, Hepatic funct. & SOFA score, Temp.; From random.to ICU discharge/day 28 (once daily): RRT need, Urine output, Days on RRT, Con. Med.; From random. to ICU discharge/day 28 (cont.): (S)AEs / (S)ARs, Number of blood product units, Vasopressor/inotropic therapy, Add. admin. cryst. solutions, Fluid balance; From random. until ICU discharge/day 28: within the first 6 hrs every 2 hrs, then every 12 hrs; from 48 hrs until ICU discharge/day 28 (once daily): Tissue oxygenat. /acid base balance, S. electrolytes; Cumul.: infection/antibiotic/ventilator/vasopressor free days; Day 28: Last available SCr, Colloid therapy, Day 28 + 90: Mortality & cause of death (if applic.), Day 90: HRQoL, New RRT/kidney disease

E.5.2.1

Timepoint(s) of evaluation of this end point

See section E.5.2

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

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

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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)

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

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

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

Completion of last follow up of 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:

304

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

304

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-08-10.

Yes

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

Yes

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Study indication is severe sepsis or septic shock, therefore patients are in an emergency situation. In the setting of emergency situation, requiring ICU admission / immediate medical treatment, the patients will not be able to consent personally.

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

400

F.4.2

For a multinational trial

F.4.2.1

In the EEA

608

F.4.2.2

In the whole clinical trial

608

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)

Not different from the expected normal treatment of that condition. Treatment after study end is left to Medical standard of Care.

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

2015-11-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-11-04

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2021-12-08

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