Clinical Trials Register

Summary
EudraCT Number:	2011-001819-30
Sponsor's Protocol Code Number:	Sano2011
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:	2011-07-18
Trial results	View 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

2011-001819-30

A.3

Full title of the trial

Detection of non-muscle invasive bladder cancer using PVP-Hypericin (Vidon®) fluorescence cystoscopy (Hypericin PDD)

A.3.1

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

Detection of bladder cancer using a fluorescent dye (PVP-Hypericin)

A.4.1

Sponsor's protocol code number

Sano2011

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	Sanochemia Pharmazeutika AG
B.1.3.4	Country	Austria
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	Sanochemia Pharmazeutika AG
B.4.2	Country	Austria
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Sanochemia Pharmazeutika AG
B.5.2	Functional name of contact point	Clinical Department
B.5.3	Address:
B.5.3.1	Street Address	Boltzmanngasse 11
B.5.3.2	Town/ city	Vienna
B.5.3.3	Post code	1090
B.5.3.4	Country	Austria
B.5.4	Telephone number	004313191456435
B.5.5	Fax number	004313191456453
B.5.6	E-mail	Sano2011@sanochemia.at

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	Vidon
D.3.2	Product code	PVP-Hypericin
D.3.4	Pharmaceutical form	Powder for intravesical solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravesical use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	548-04-9
D.3.9.2	Current sponsor code	SPH-3542
D.3.9.3	Other descriptive name	Hypericin
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	225
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Suspected non-muscle invasive (superficial) bladder cancer

E.1.1.1

Medical condition in easily understood language

Suspected bladder cancer

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.0
E.1.2	Level	PT
E.1.2	Classification code	10005003
E.1.2	Term	Bladder cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To collect preliminary data on the diagnostic performance of Hypericin-guided cystoscopy regarding the detection of non-muscle invasive
bladder cancer . Standard, white light cystoscopy will be compared with
Hypericin assisted cystoscopy (PVP-Hypericin instillation; white light
followed by blue light (Hypericin PDD)) using a within-patient design by
inspecting the bladder under white light first, followed by blue light.

E.2.2

Secondary objectives of the trial

• Diagnostic performance regarding flat and papillary tumours
• False-positive rate
• To evaluate systemic absorption and pharmacokinetics (PK) of
Hypericin after a single intravesical instillation of PVP-Hypericin in a
sub-group of patients (N=15-20)
• To assess the safety of PVP-Hypericin.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients who have given their signed declaration of consent and data
protection declaration
2. Males and females aged ≥ 18 years
3. Patients scheduled for transurethral resection of the bladder of a suspected bladder
cancer based on recent findings in cystoscopy that have to be diagnosed at the
respective study site prior to Visit 1
4. Patients including multiple bladder tumours or suspicious lesions
5. Patients with initial and/or recurrent bladder cancer
6. Patients with adequate renal and hepatic function according to the
investigator
7. No known anaesthetic risks (risk of narcosis ASA 1-3)
8. All women of child-bearing potential must have a negative serum or
urine pregnancy test at screening and must use hormonal contraception
or intrauterine device (IUD) during the treatment and for at least one
month thereafter.

E.4

Principal exclusion criteria

1. Intravesical BCG (Bacillus Calmette-Guérin) instillation ≤ 6 months
2. Intravesical Mitomycin instillation ≤ 3 months
3. Patients at high risk of suffering extensive bladder inflammation
4. Recent bladder surgery (resection) ≤ 3 months
5. Patients with symptoms and signs of urinary tract infection, e.g.
moderate or severe leukocyturia, dysuria, alguria, urgency, frequency,
polyuria, offensive urine, cloudy urine, significant bacteriuria (≥ 100000
CFU/mL), positive urine culture, asymptomatic bacteriuria, suprapubic
tenderness, pain or pressure, flank or back pain, fever ≥ 38°C,
costovertebral angle tenderness
6. Macroscopic hematuria
7. Bladder stones
8. Bladder capacity ≤ 50 mL
9. Administration of any other photosensitiser < 6 months
10. Oral intake of any drug or substance containing Hypericum extract,
Hypericin, Pseudohypericin or parts of Hypericum plants (capsules,
tablets, powder, drops, teas, etc.) within 14 days prior to PDD, during the study and until
Visit 4 for patients included in the PK subgroup
11. All anticoagulation therapy except low dose heparin and aspirin
12. Known allergy to Hypericin, polyvinylpyrrolidone (PVP, povidone) or
any similar compounds
13. Pregnant or breast-feeding women
14. Participation in other clinical studies with investigational drugs
either concurrently or within the last 30 days
15. Previous participation in this clinical study
16. Conditions associated with a risk of poor protocol compliance
17. Patients with mental health problems
18. Patients who have difficulties in understanding the language in
which the patient information is given
19. Legal incapacity and/or other circumstances rendering the patient
unable to understand the nature, scope and possible impact of the study
20. Patients in custody by juridical or official order
21. Staff of the study centre, staff of the sponsor or CRO, the
investigator him-/herself or close relatives of the investigator

E.5 End points

E.5.1

Primary end point(s)

The percentage of patients in whom non-muscle invasive bladder cancer
(Tis and / or TaT1) is detected by Hypericin cystoscopy (PVP-Hypericin
instillation; white light followed by blue light) as confirmed by biopsy
results.

E.5.1.1

Timepoint(s) of evaluation of this end point

after LVLS

E.5.2

Secondary end point(s)

• The primary endpoint variable for Tis and TaT1 separately (on patient
and lesion level)
• False-positive rate
• Systemic absorption and pharmacokinetics of Hypericin after a singledose
intravesical PVP-Hypericin (sub-group analysis)
• Frequency and severity of systemic and local adverse events (AE)

E.5.2.1

Timepoint(s) of evaluation of this end point

after LVLS

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

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

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

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

within-patient comparison

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

white light detection, standard of diagnosis

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

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

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:

165

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

165

F.4.2

For a multinational trial

F.4.2.1

In the EEA

220

F.4.2.2

In the whole clinical trial

220

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 applicable.

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

2011-10-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-10-18

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-07-19

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