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Clinical Trial Results:
Detection of non-muscle invasive bladder cancer using PVP-Hypericin (Vidon®) fluorescence cystoscopy (Hypericin PDD) A multi-centre, open, within-patient comparison, Phase IIb study

Summary
EudraCT number	2011-001819-30
Trial protocol	DE AT
Global end of trial date	19 Jul 2014

Results information
Results version number	v1(current)
This version publication date	26 Sep 2020
First version publication date	26 Sep 2020
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

Sano2011

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Sanochemia Pharmazeutika AG

Sponsor organisation address

Boltzmanngasse 11, Vienna, Austria, 1090

Public contact

Clinical Department, Sanochemia Pharmazeutika AG, Sano2011@sanochemia.at

Scientific contact

Clinical Department, Sanochemia Pharmazeutika AG, Sano2011@sanochemia.at

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

19 Jul 2014

Is this the analysis of the primary completion data?

Yes

Primary completion date

19 Jul 2014

Global end of trial reached?

Yes

Global end of trial date

19 Jul 2014

Was the trial ended prematurely?

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.

Protection of trial subjects

The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP). Before entering the study, the informed consent form was read by and explained to all subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.

Background therapy

Evidence for comparator

Actual start date of recruitment

27 Oct 2011

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Austria: 53

Country: Number of subjects enrolled

Germany: 169

Worldwide total number of subjects

222

EEA total number of subjects

222

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

145

85 years and over

Subject disposition

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Recruitment details

Adult male and female patients with a cystoscopically suspected bladder neoplasm scheduled for transurethral resection of the bladder (TURB) were screened at 10 investigational study sites (urology clinics) in 2 countries: Austria (2) and Germany (8) between 27 OCT 2011 (FPFV) and 19 JUL 2014 (LPLV).

Screening details

Overall 227 patients were screened; 5 patients were screening failures (2 patients withrew their consent, 1 patient had unacceptable laboratory values, and 2 patients were not enrolled due to other reasons) and 222 patients were assigned to Hypericin PDD and TUR-B.

Period 1 title

Overall trial / SEP (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Hypericin PDD

Arm description

Within-patient design for comparison of standard, white light cystoscopy, with Hypericin-assisted cystoscopy (instillation of PVP-Hypericin, complete cystoscopic examination of the entire bladder under white light and then complete examination of the entire bladder surface under blue light; transurethral resection of the bladder).

Arm type

Within-patient comparison

Investigational medicinal product name

PVP-Hypericin

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solvent for intravesical solution

Routes of administration

Intravesical use

Dosage and administration details

IMP: 225 μg Sodium hypericin, 22.5 mg Polyvinylpyrrolidone and buffer (as lyophilized powder for reconstitution with water for injection). Mode of Administration: Intravesical instillation via a urinary catheter. Single intravesical instillation of 30 (+ 5) minutes duration followed by emptying of the bladder.

Number of subjects in period 1	Hypericin PDD
Started	222
Completed	222

Baseline characteristics

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Reporting group title

Overall trial / SEP

Reporting group description

Safety Evaluable Population (SEP): the safety population included all treated patients with post-treatment efficacy data. The SEP was analysed mainly with respect to drug safety. Of 222 patients assigned to photodynamic diagnosis (PDD) using Hypericin and TUR-B, 50 patients were used to standardise the study procedures (training patients), and 172 patients were regular patients. 2 patients terminated the study prematurely after Visit 2. TUR-B was not done in both patients either because of the appearance of a nontolerable AE which was not related to the study medication or due to problems with the blue light of the PDD System. Among the 172 regular patients, 20 patients were included in the subgroup with PK sampling. All 222 patients (50 training patients and 172 regular patients) received a single intravesical instillation of 50 mL reconstituted solution containing 225 μg Hypericin for PDD of bladder cancer at Visit 2 (day of surgery).

Reporting group values	Overall trial / SEP	Total
Number of subjects	222	222
Age categorical
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	0	0
Adolescents (12-17 years)	0	0
Adults (18-64 years)	61	61
From 65-84 years	145	145
85 years and over	16	16
Age continuous
Units: years
median (standard deviation)	69.6 ± 10.6	-
Gender categorical
Units: Subjects
Female	43	43
Male	179	179
Ethnic origin
Units: Subjects
White	222	222
Initial and/or recurrent bladder cancer
Patients with initial and/or recurrent bladder cancer were scheduled for TUR-B of a suspected bladder cancer based on recent cystoscopic findings.
Units: Subjects
multiple tumours / suspicious lesions present	221	221
one suspicious lesion only	1	1
Pre-study cystoscopy
Units: Subjects
Pre-study cystoscopy done at study site	220	220
Not done at study site	2	2
Baseline 12-lead ECG done at study site
A baseline 12-lead ECG was done in 209/222 patients included in the SEP. The baseline ECG (Visit 1) was missing for 13/222 patients most commonly due to an error by the study site (10 patients), or because a pre-study ECG was available (2 patients), or due to logistic reasons (1 Patient) (SEP).
Units: Subjects
ECG done	209	209
ECG missing	13	13
Findings in 12-lead ECG
A baseline 12-lead ECG was done in 209/222 patients included in the SEP. Of the 209 patients who had a 12-lead ECG recorded at baseline, 41 patients had abnormal findings.
Units: Subjects
Abnormal findings	41	41
No findings	168	168
ECG Missing	13	13
Physical examination performed
Units: Subjects
Yes	221	221
No	1	1
Vital signs measured
Units: Subjects
Yes	221	221
No	1	1
Findings Interfering with PVP-Hypericin
Units: Subjects
No	221	221
Yes	0	0
Missing	1	1
Urine culture / urine pH
Units: Subjects
Normal	212	212
Abnormal	10	10
Urinalysis Erythrocytes
Baseline urinalysis
Units: Subjects
Pos	126	126
Neg	94	94
Nd	0	0
Missing	2	2
Urinalysis Leucocytes
Baseline urinalysis
Units: Subjects
Pos	47	47
Neg	173	173
Nd	2	2
Missing	0	0
Urinalysis Nitrite
Baseline Urinalysis
Units: Subjects
Pos	4	4
Neg	216	216
Nd	2	2
Missing	0	0
Urinalysis Urine culture
Baseline Urinalysis
Units: Subjects
Pos	20	20
Neg	192	192
Nd	10	10
Missing	0	0
Height
Units: cm
arithmetic mean (standard deviation)	173.1 ± 7.64	-
Weight
Units: kg
arithmetic mean (standard deviation)	80.9 ± 15.02	-

Subject analysis set title

Diagnostic Performance / Full Analysis Set (FAS)

Subject analysis set type

Full analysis

Subject analysis set description

Full Analysis Set (FAS) The FAS for the efficacy analyses included all treated patients with available data to evaluate the primary endpoint. This meant, that both treatments (white light and blue light) had to be applied and the respective efficacy data were required in order to calculate the primary endpoint. This analysis set was used for the confirmatory test of the primary endpoint. Of 222 patients assigned to photodynamic diagnosis (PDD) using Hypericin and TUR-B, 50 patients were used to standardise the study procedures (training patients), and 172 patients were regular patients. Of 172 regular patients who had Hypericin PDD, 2 patients terminated the study prematurely after Visit 2.

Subject analysis set title

Efficacy Ta lesions

Subject analysis set type

Sub-group analysis

Subject analysis set description

Full Analysis Set (FAS) / subgroup Ta: Diagnostic performance regarding papillary tumours per patient; detection rate of Hypericin PDD versus standard (white light) cystoscopy for Ta lesions separately on a per patient level.

Subject analysis set title

Efficacy T1 lesions

Subject analysis set type

Sub-group analysis

Subject analysis set description

Full Analysis Set (FAS) / subgroup T1: Diagnostic performance regarding papillary tumours per patient; detection rate of Hypericin PDD versus standard (white light) cystoscopy for T1 lesions separately on a per patient level.

Subject analysis set title

Efficacy Tis lesions

Subject analysis set type

Sub-group analysis

Subject analysis set description

Full Analysis Set (FAS) / subgroup Tis: Diagnostic performance regarding flat tumours per patient; detection rate of Hypericin PDD versus standard (white light) cystoscopy for Tis lesions separately on a per patient level.

Subject analysis set title

False-positive Rate

Subject analysis set type

Full analysis

Subject analysis set description

Detection rates of benign lesions as false positive rates on a per patient level. False positive rate was derived as the number of false positive lesions detected with white or blue light divided by the total number of lesions suspected with white light or blue light, respectively.

Subject analysis set title

Pharmacokinetic (PK)

Subject analysis set type

Sub-group analysis

Subject analysis set description

The PK subgroup (20 patients) included all FAS patients with PK sampling who had a second postoperative control examination (Visit 4) and valid data for the evaluation of Hypericin pharmacokinetics.

Subject analysis sets values	Diagnostic Performance / Full Analysis Set (FAS)	Efficacy Ta lesions	Efficacy T1 lesions	Efficacy Tis lesions	False-positive Rate	Pharmacokinetic (PK)
Number of subjects	170	124	45	20	103	20
Age categorical
Units: Subjects
In utero	0
Preterm newborn infants (gestational age < 37 wks)	0
Newborns (0-27 days)	0
Infants and toddlers (28 days-23 months)	0
Children (2-11 years)	0
Adolescents (12-17 years)	0
Adults (18-64 years)	47
From 65-84 years	111
85 years and over	12
Age continuous
Units: years
median (standard deviation)	69.3 ± 10.85	±	±	±	±	±
Gender categorical
Units: Subjects
Female	33
Male	137
Ethnic origin
Units: Subjects
White	170
Initial and/or recurrent bladder cancer
Patients with initial and/or recurrent bladder cancer were scheduled for TUR-B of a suspected bladder cancer based on recent cystoscopic findings.
Units: Subjects
multiple tumours / suspicious lesions present	169
one suspicious lesion only	1
Pre-study cystoscopy
Units: Subjects
Pre-study cystoscopy done at study site	168
Not done at study site	2
Baseline 12-lead ECG done at study site
A baseline 12-lead ECG was done in 209/222 patients included in the SEP. The baseline ECG (Visit 1) was missing for 13/222 patients most commonly due to an error by the study site (10 patients), or because a pre-study ECG was available (2 patients), or due to logistic reasons (1 Patient) (SEP).
Units: Subjects
ECG done	165
ECG missing	5
Findings in 12-lead ECG
A baseline 12-lead ECG was done in 209/222 patients included in the SEP. Of the 209 patients who had a 12-lead ECG recorded at baseline, 41 patients had abnormal findings.
Units: Subjects
Abnormal findings	35
No findings	130
ECG Missing	5
Physical examination performed
Units: Subjects
Yes	170
No	170
Vital signs measured
Units: Subjects
Yes	169
No	1
Findings Interfering with PVP-Hypericin
Units: Subjects
No	170
Yes	0
Missing	0
Urine culture / urine pH
Units: Subjects
Normal	162
Abnormal	8
Urinalysis Erythrocytes
Baseline urinalysis
Units: Subjects
Pos	96
Neg	72
Nd	0
Missing	2
Urinalysis Leucocytes
Baseline urinalysis
Units: Subjects
Pos	33
Neg	135
Nd	2
Missing	0
Urinalysis Nitrite
Baseline Urinalysis
Units: Subjects
Pos	2
Neg	166
Nd	2
Missing	0
Urinalysis Urine culture
Baseline Urinalysis
Units: Subjects
Pos	15
Neg	146
Nd	9
Missing	0
Height
Units: cm
arithmetic mean (standard deviation)	173.0 ± 7.79	±	±	±	±	±
Weight
Units: kg
arithmetic mean (standard deviation)	81.6 ± 15.38	±	±	±	±	±

End points

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Reporting group title

Hypericin PDD

Reporting group description

Subject analysis set title

Diagnostic Performance / Full Analysis Set (FAS)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Efficacy Ta lesions

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Efficacy T1 lesions

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Efficacy Tis lesions

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

False-positive Rate

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Pharmacokinetic (PK)

Subject analysis set type

Sub-group analysis

Subject analysis set description

The PK subgroup (20 patients) included all FAS patients with PK sampling who had a second postoperative control examination (Visit 4) and valid data for the evaluation of Hypericin pharmacokinetics.

Primary: Diagnostic performance of Hypericin-assisted cystoscopy / Sensitivity per patient

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End point title

Diagnostic performance of Hypericin-assisted cystoscopy / Sensitivity per patient ^[1]

End point description

The primary endpoint variable was the percentage of patients in whom non-muscle invasive bladder cancer (Tis and/or Ta/T1) is detected by Hypericin-assisted cystoscopy (PVP-Hypericin instillation;white light followed by blue light) as confirmed by biopsy results. The primary endpoint was defined as the percentage of patients in whom additional non-muscle invasive bladder cancer (Tis and/or Ta/T1) could be detected by Hypericin-assisted cystoscopy compared to standard white light cystoscopy, as confirmed by biopsy results.

End point type

Primary

End point timeframe

Visit 2 (day of surgery) and biopsy result (after visit 3/4).

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The database does not allow for statistical analysis for studies with a single arm within-patient comparison. A confirmatory analysis was done for the primary endpoint. A confirmatory analysis (one-sided Mc- Nemar Test) was done in the FAS for the primary endpoint. All further statistical analyses were explorative.

End point values	Diagnostic Performance / Full Analysis Set (FAS)
Number of subjects analysed	170
Units: Improved sensitivity / Difference in %
number (confidence interval 95%)	17.8 (9.8 to 25.3)

No statistical analyses for this end point

Secondary: Diagnostic performance regarding flat and papillary tumours per patient

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End point title

Diagnostic performance regarding flat and papillary tumours per patient

End point description

Detection rate of Hypericin PDD versus standard (white light) cystoscopy for Tis, Ta and T1 lesions separately on a per patient level.

End point type

Secondary

End point timeframe

Visit 2 (day of surgery) and biopsy result (after Visit 3/4)

End point values	Efficacy Ta lesions	Efficacy T1 lesions	Efficacy Tis lesions
Number of subjects analysed	124	45	20
Units: Improved sensitivity / Difference in %
number (confidence interval 95%)	14.5 (6.9 to 21.7)	13.3 (0.8 to 24.7)	35.0 (4.0 to 59.7)

No statistical analyses for this end point

Secondary: False Positive Rate per patient

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End point title

False Positive Rate per patient

End point description

The false positive rate was derived as the number of false positive lesions detected with white or blue light divided by the total number of lesions suspected with white light or blue light, respectively. The false positive rate was calculated for standard white light and Hypericin PDD using the McNemar test for paired proportions.

End point type

Secondary

End point timeframe

Visit 2 (day of surgery) and biopsy result (after Visit 3/4)

End point values	False-positive Rate
Number of subjects analysed	103
Units: Difference in false positive rates in %
number (confidence interval 95%)	14.6 (-0.2 to 28.7)

No statistical analyses for this end point

Secondary: Pharmacokinetic

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End point title

Pharmacokinetic

End point description

Systemic absorption and pharmacokinetics of Hypericin after a single intravesical instillation of PVP-Hypericin (sub-group analysis).

End point type

Secondary

End point timeframe

Blood sampling for pharmacokinetics was done frequently, 24 hour-profile, from Visit 2 (before surgery) to Visit 3 (1st post-operative day), and once on Visit 4 (7th - 8th postoperative day) to obtain a complete pharmacokinetic profile.

End point values	Pharmacokinetic (PK)
Number of subjects analysed	20
Units: ng/mL
number (not applicable)	0

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Adverse events were recorded in detail (starting with insertion of the urinary catheter for instillation of PVP-Hypericin), at each post-baseline assessment (Visits 2 - 3 and Visits 2 - 4 for the sub-group with PK sampling, respectively).

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

Safety evaluable population (SEP)

Reporting group description

Serious adverse events	Safety evaluable population (SEP)
Total subjects affected by serious adverse events
subjects affected / exposed	20 / 222 (9.01%)
number of deaths (all causes)	0
number of deaths resulting from adverse events	0
Injury, poisoning and procedural complications
Bladder perforation
subjects affected / exposed	2 / 222 (0.90%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Post procedural haemorrhage
subjects affected / exposed	14 / 222 (6.31%)
occurrences causally related to treatment / all	0 / 14
deaths causally related to treatment / all	0 / 0
Urinary retention postoperative
subjects affected / exposed	2 / 222 (0.90%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Vascular disorders
Deep vein thrombosis
subjects affected / exposed	2 / 222 (0.90%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
subjects affected / exposed	1 / 222 (0.45%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Renal and urinary disorders
Hydronephrosis
subjects affected / exposed	2 / 222 (0.90%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Renal pain
subjects affected / exposed	1 / 222 (0.45%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Infections and infestations
Urinary tract infection
subjects affected / exposed	1 / 222 (0.45%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Safety evaluable population (SEP)
Total subjects affected by non serious adverse events
subjects affected / exposed	115 / 222 (51.80%)
Investigations
Blood glucose fluctuation
subjects affected / exposed	1 / 222 (0.45%)
occurrences all number	1
Body temperature increased
subjects affected / exposed	1 / 222 (0.45%)
occurrences all number	1
Transaminases increased
subjects affected / exposed	1 / 222 (0.45%)
occurrences all number	1
Injury, poisoning and procedural complications
Application site pain
subjects affected / exposed	2 / 222 (0.90%)
occurrences all number	2
Catheter site pain
subjects affected / exposed	1 / 222 (0.45%)
occurrences all number	1
Device occlusion
subjects affected / exposed	1 / 222 (0.45%)
occurrences all number	1
Post procedural constipation
subjects affected / exposed	2 / 222 (0.90%)
occurrences all number	2
Post procedural haemorrhage
subjects affected / exposed	68 / 222 (30.63%)
occurrences all number	68
Postoperative fever
subjects affected / exposed	1 / 222 (0.45%)
occurrences all number	1
Procedural pain
subjects affected / exposed	16 / 222 (7.21%)
occurrences all number	16
Puncture site pain
subjects affected / exposed	1 / 222 (0.45%)
occurrences all number	1
Urinary retention postoperative
subjects affected / exposed	1 / 222 (0.45%)
occurrences all number	1
Vascular disorders
Hypertension
subjects affected / exposed	5 / 222 (2.25%)
occurrences all number	5
General disorders and administration site conditions
Application site irritation
subjects affected / exposed	1 / 222 (0.45%)
occurrences all number	1
Catheter site pain
subjects affected / exposed	2 / 222 (0.90%)
occurrences all number	2
Flank pain
subjects affected / exposed	2 / 222 (0.90%)
occurrences all number	2
Immune system disorders
Seasonal allergy
subjects affected / exposed	1 / 222 (0.45%)
occurrences all number	1
Gastrointestinal disorders
Abdominal pain lower
subjects affected / exposed	1 / 222 (0.45%)
occurrences all number	1
Abdominal pain upper
subjects affected / exposed	1 / 222 (0.45%)
occurrences all number	1
Constipation
subjects affected / exposed	1 / 222 (0.45%)
occurrences all number	1
Diarrhoea
subjects affected / exposed	4 / 222 (1.80%)
occurrences all number	4
Nausea
subjects affected / exposed	2 / 222 (0.90%)
occurrences all number	2
Vomiting
subjects affected / exposed	2 / 222 (0.90%)
occurrences all number	2
Respiratory, thoracic and mediastinal disorders
Dyspnoea
subjects affected / exposed	1 / 222 (0.45%)
occurrences all number	1
Skin and subcutaneous tissue disorders
Rash
subjects affected / exposed	2 / 222 (0.90%)
occurrences all number	2
Psychiatric disorders
Insomnia
subjects affected / exposed	1 / 222 (0.45%)
occurrences all number	1
Renal and urinary disorders
Bladder spasm
subjects affected / exposed	22 / 222 (9.91%)
occurrences all number	22
Dysuria
subjects affected / exposed	1 / 222 (0.45%)
occurrences all number	1
Hydronephrosis
subjects affected / exposed	1 / 222 (0.45%)
occurrences all number	1
Urinary bladder haemorrhage
subjects affected / exposed	1 / 222 (0.45%)
occurrences all number	1
Infections and infestations
Urinary tract infection
subjects affected / exposed	3 / 222 (1.35%)
occurrences all number	3

More information

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Were there any global substantial amendments to the protocol? Yes

17 Mar 2012

The amendment was requested by Sanochemia Pharmazeutika AG after first practical experience with the protocol. Adaptations of the respective inclusion diagnosis and inclusion criteria were made. In addition, the section about sample size was changed in order to allow an increased enrolment of further training patients, if deemed necessary. Furthermore, some administrative changes were included. These changes have substantial implications on the population of patients and the conduct of the study.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
Detection of non-muscle invasive bladder cancer using PVP-Hypericin (Vidon®) fluorescence cystoscopy (Hypericin PDD) A multi-centre, open, within-patient comparison, Phase IIb study

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Diagnostic performance of Hypericin-assisted cystoscopy / Sensitivity per patient

Primary: Diagnostic performance of Hypericin-assisted cystoscopy / Sensitivity per patient

Secondary: Diagnostic performance regarding flat and papillary tumours per patient

Secondary: Diagnostic performance regarding flat and papillary tumours per patient

Secondary: False Positive Rate per patient

Secondary: False Positive Rate per patient

Secondary: Pharmacokinetic

Secondary: Pharmacokinetic

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

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Clinical trials

Clinical Trial Results: Detection of non-muscle invasive bladder cancer using PVP-Hypericin (Vidon®) fluorescence cystoscopy (Hypericin PDD) A multi-centre, open, within-patient comparison, Phase IIb study

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Diagnostic performance of Hypericin-assisted cystoscopy / Sensitivity per patient

Primary: Diagnostic performance of Hypericin-assisted cystoscopy / Sensitivity per patient

Secondary: Diagnostic performance regarding flat and papillary tumours per patient

Secondary: Diagnostic performance regarding flat and papillary tumours per patient

Secondary: False Positive Rate per patient

Secondary: False Positive Rate per patient

Secondary: Pharmacokinetic

Secondary: Pharmacokinetic

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
Detection of non-muscle invasive bladder cancer using PVP-Hypericin (Vidon®) fluorescence cystoscopy (Hypericin PDD) A multi-centre, open, within-patient comparison, Phase IIb study