Clinical Trials Register

Summary
EudraCT Number:	2012-004406-10
Sponsor's Protocol Code Number:	000
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2013-07-25
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

Czechia - SUKL

A.2

EudraCT number

2012-004406-10

A.3

Full title of the trial

The use of oxygen and hydrogen mixture for inhalation to prevent ischaemia-reperfusion injury

Inhalační aplikace směsi kyslíku a vodíku k prevenci ischemicko-reperfuzního poškození

A.3.1

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

The use of oxygen-hydrogen mixture as an antioxidant

Aplikace směsi kyslíku a vodíku jako antioxidantu

A.3.2

Name or abbreviated title of the trial where available

"Hydrogen"

"Vodík"

A.4.1

Sponsor's protocol code number

000

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	University Hospital Hradec Kralove
B.1.3.4	Country	Czech Republic
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	University Hospital Hradec Kralove
B.4.2	Country	Czech Republic
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	University Hospital Hradec Kralove
B.5.2	Functional name of contact point	Center for Research and Development
B.5.3	Address:
B.5.3.1	Street Address	Sokolska 581
B.5.3.2	Town/ city	Hradec Kralove
B.5.3.3	Post code	500 05
B.5.3.4	Country	Czech Republic
B.5.4	Telephone number	420495832241
B.5.5	Fax number	420495834841
B.5.6	E-mail	rhyspler@lfhk.cuni.cz

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	Nitrogen-oxygen-hydrogen gas mixture (58%-40%-2%, respectively) for inhalation
D.3.4	Pharmaceutical form	Medicinal gas, compressed
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Inhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	OXYGEN
D.3.9.3	Other descriptive name	oxygen gas
D.3.9.4	EV Substance Code	SUB14733MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (V/V) percent volume/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
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

The patients suffering form acute transmural myocardial infarction and treated with percutaneous transluminal coronary angioplasty will be included in the study. After the recanalisation of occluded artery, the reperfusion injury develops and the regeneration of ischemic tissue is impaired. The reactive oxygen species are partly responsible for reperfusion injury pathogenesis.

Do studie budou zařazeni pacienti s akutním transmurálním infarktem myokardu léčení perkutánní transluminální koronární angioplastikou. Po rekanalizaci okludované cévy dochází k reperfuznímu poškození, které zhoršuje regeneraci ischemické tkáně. Na patogenezi reperfuzního poškození se částečně podílí reaktivní kyslíkové radikály.

E.1.1.1

Medical condition in easily understood language

The patients suffering from heart attack will be included into the study.

Do studie bidou zařazeni pacienti postižení akutním infarktem myokardu.

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

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

Due to the fast growing body of information regarding positive effects of oxygen - hydrogen mixtures in various clinical conditions, it is necessary to evaluate its positive potential in the case of acute coronary angioplasty, where its fast diffusibility is especially profitable.

Vzhledem k rychlému nárůstu informací o pozitivních účincích směsi kyslíku a vodíku v různých klinických situacích za posledních pět let, je nezbytné vyhodnotit její potenciál v situaci akutní koronární angioplastiky, kdy vysoká difuzibilita složek směsi je vlastností zvláště výhodnou.

E.2.2

Secondary objectives of the trial

Althouth there are not any available data regarding hydrogen toxicity and 2% concentration is low, the safety of oxygen - hydrogen mixture must be validated in the situation of acute coronary angioplasty.

I když nejsou známa žádná data o toxicitě vodíku a 2%ní koncentrace ve směsi je nízká, bezpečnost aplikace směsi kyslíku a vodáíku v situaci akutní koronární angioplastiky musí být potvrzena.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

The patients, aged 50-75 years (postmenopausal women only), suffering from acute myocardial infarction, transmural, originating from large vessel damage, will be included in the study. There cannot be any previous myocardial infarction, any previous cardiosurgery or cardiogenic shock present (Kyllip 1-3).

Do studie budou zařazováni pacienti ve věkovém intervalu 50-75 let (ženy po menopauze) s akutním infarktem myokardu, transmurálním, vzniklým z poškození proximální části velké cévy. Bude se jednat o první infarkt v životě pacienta, pacient bude bez předchozího kardiochirurgického zákroku a bez přítomnosti kardiogenního šoku (Kyllip 1-3).

E.4

Principal exclusion criteria

Cardiogenic shock development, participation in another study, previus cardiosurgery, impossibility of primary PCI, diabetic decompensation, serious anamnestic nephropathy, serius anamnestic hepatopathy, cancer disease at present or previous five years, other serious comorbidities.

Rozvoj kardiogenního šoku, účast v jiné studii, předchozí kardiochirurgický zákrok, nemožnost provést primární PCI, dekompenzovaný diabetes, závažná nefropatie dle anamnézy, závažná hepatopatie dle anamnézy, nádorové onemocnění v současnosti nebo v posledních pěti letech, případně jiné závažné komorbidity.

E.5 End points

E.5.1

Primary end point(s)

The primary end-point is the effectivity evaluation of inhalational application of oxygen-hydrogen mixture against conventional oxygenotherapy on residual myocardial damage.

Primárním cílem sledování je zhodnocení účinnosti inhalační aplikace směsi kyslíku s vodíkem oproti standardní oxygenoterapii na snížení rozsahu reziduálního myokardiálního poškození.

E.5.1.1

Timepoint(s) of evaluation of this end point

Visit 1: Patient iclusion into the study (day 0)
Visit 2: The end of coronary angioplasty (day 0)
Visit 3:Admission to ICU (day 0)
Visit 4: The morning of following day (day 1)Visit 5: The morning of following day (day 2)
Visit 6: The day of patient discharge.

Vizita 1: Při zařazení pacienta do studie (den 0).
Vizita 2: Konec angioplastického výkonu (den 0).
Vizita 3: Příjem na JIP (den 0)
Vizita 4: Následující den ráno (den 1).
Vizita 5: Následující den ráno (den 2)
Vizita 6: Při dimisi nebo překladu pacienta.

E.5.2

Secondary end point(s)

The secondary end-point is the safety evaluation of inhalational application of oxygen(40%) -hydrogen (2%) mixture during coronary angioplasty.

Sekundárním cílem sledování je zhodnocení bezpečnosti inhalační aplikace 2 % vodíku ve vdechované směsi v průběhu koronární angioplastiky.

E.5.2.1

Timepoint(s) of evaluation of this end point

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

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

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Standardní aplikace kyslíku (FiO2 40%)

Standard oxygen therapy (FiO2 40%)

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the 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:

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

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

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

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.

Žádné.

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

2013-10-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-09-11

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

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