Clinical Trials Register

Summary
EudraCT Number:	2020-000147-31
Sponsor's Protocol Code Number:	19-211
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-09-02
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

Belgium - FPS Health-DGM

A.2

EudraCT number

2020-000147-31

A.3

Full title of the trial

VItamin C in Thermal injuRY: The VICToRY Pilot Trial
A feasibility study for a seamless adaptive phase II/III multi-center randomized trial

Vitamine C bij thermisch letsel: VICToRY Pilot Trial.
Een haalbaarheidsstudie voor een adaptieve Fase II/III multicentrische, gerandomiseerde studie.

A.3.1

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

VItamin C in Thermal injuRY: The VICToRY Pilot Trial
A feasibility study for a seamless adaptive phase II/III multi-center randomized trial

Vitamine C bij thermisch letsel: VICToRY Pilot Trial.
Een haalbaarheidsstudie voor een adaptieve Fase II/III multicentrische, gerandomiseerde studie.

A.3.2

Name or abbreviated title of the trial where available

The VICToRY Trial

A.4.1

Sponsor's protocol code number

19-211

A.5.4

Other Identifiers

Name:

Clinical trials.gov

Number:

NCT04138394

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	Clinical Evaluation Research Unit
B.1.3.4	Country	Canada
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	WÖRWAG Pharma GmbH & Co. KG
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	Clinical Evaluation Research Unit
B.5.2	Functional name of contact point	Clinical Progr. Manager/Coordinator
B.5.3	Address:
B.5.3.1	Street Address	76 Stuart Street
B.5.3.2	Town/ city	Kingston
B.5.3.3	Post code	ON K7L 2V7
B.5.3.4	Country	Canada
B.5.4	Telephone number	+16138884320
B.5.6	E-mail	maureen.dansereau@queensu.ca

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	Vitamin C 1000 Injektionslösung
D.2.1.1.2	Name of the Marketing Authorisation holder	WÖRWAG Pharma GmbH & Co. KG
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	Vitamin C
D.3.4	Pharmaceutical form	Solution for injection/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	ASCORBIC ACID
D.3.9.3	Other descriptive name	Vitamin C
D.3.9.4	EV Substance Code	SUB05579MIG
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	200
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	Solution for injection/infusion
D.8.4	Route of administration of the placebo	Intravenous use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection/infusion
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

Severely burned patients

E.1.1.1

Medical condition in easily understood language

Severely burned patients

E.1.1.2

Therapeutic area

Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

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	10006634
E.1.2	Term	Burn
E.1.2	System Organ Class	100000004863

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 objective of this pilot trial is to demonstrate feasibility and safety of a high-dose intravenous vitamin C administration in 180 severely burned patients.

E.2.2

Secondary objectives of the trial

a) to gain first information about the safety and pharmacokinetics of highdose intravenous vitamin C in this patient population
b) determine possible endpoints for a definitive study, and
c) to evaluate the oxidation-reduction potential as a new biomarker for oxidative stress.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

18 years of age or older with deep 2nd and/or 3rd degree burns, who are assessed as requiring skin grafting, and a minimum burn size ≥ 20% Total Body Surface Area (TBSA).
Patients with smaller burns are less likely to require fluid resuscitation and their risk of morbidity and mortality is lower. Burn size will be determined by the attending physician (and confirmed by the attending surgeon if it is not the same person).

E.4

Principal exclusion criteria

1. >24 hours from admission to ICU or burn unit to assessment.
2. Patients admitted to burn unit >24 hours from injury or accident.
3. Patients who are moribund (not expected to survive the next 72 hours).
4. Pregnancy (pregnancy will be ruled out as part of standard of care) or lactating.
5. Enrolment in another industry sponsored ICU interventional study
6. Receiving high-dose IV vitamin C already (enteral or oral vitamin C is allowed).
7. Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
8. Recent history of kidney stones (within the last year).

E.5 End points

E.5.1

Primary end point(s)

Feasibility metrics including compliance with the study protocol:
>90% compliance with study investigational product (IP)
<5% Lost-to-Follow up [LTFU])
low rate of consent failures (<30%)
adequate enrollment rates to support the larger confirmatory phase II/III trial.
Assessment of the pharmacokinetics and safety of the proposed dosing strategy in this patient population and the distribution of the oxidative reduction potential (ORP) as a marker of oxidative stress within treated and untreated burn patients.

E.5.1.1

Timepoint(s) of evaluation of this end point

6 Months +/- 2 Weeks

E.5.2

Secondary end point(s)

- Dose finding
- Hospital and ICU mortality
- Hospital and ICU length of stay
- ICU and hospital readmission rates
- Duration of mechanical ventilation
- Time-to-discharge alive from the hospital
- Time-to-95% graft closure (wound healing)
- In hospital bacteremia with gram-negative bacilli
- 6-month mortality
- 6 month quality of life
- Serious adverse events
- Frequency of operative procedures for burn care, antibiotic utilization, blood transfusions, and other major cost drivers (to be used for the economic evaluation)

E.5.2.1

Timepoint(s) of evaluation of this end point

6 Months +/- 2 Weeks

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

Canada

Costa Rica

Mexico

Paraguay

Singapore

Thailand

United States

Spain

Germany

Italy

Belgium

United Kingdom

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

Follow-up at 6 months will be the last visit and will define the end of the trial for the respective participant

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:

120

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 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 2022-09-02.

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

Most patients will not be able to give an informed consent. Thus, we will use an independent physician to decide on behalf of the patient about the participation. If available, Advance directive or authorized representative will be considered.

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

180

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)

Patients will be treated according to standard of care after study termination/the intervention ended.

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

2022-09-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

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

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