Clinical Trials Register

Summary
EudraCT Number:	2022-002462-32
Sponsor's Protocol Code Number:	SHW01
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-10-20
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

Austria - BASG

A.2

EudraCT number

2022-002462-32

A.3

Full title of the trial

Pilot study on the safety and feasibility of intravenous opioid agonist therapy (OAT) with Hydagelan® (hydromorphone hydrochloride) in Vienna.

Pilotstudie zur Sicherheit und Machbarkeit einer intravenösen Opioid-Agonisten-Therapie (OAT) mit Hydagelan® (Hydromorphonhydrochlorid) in Wien

A.3.1

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

Pilot study on the safety and feasibility of intravenous opioid substitution-based therapy with Hydagelan® (hydromorphone hydrochloride) in Vienna.

Pilotstudie zur Sicherheit und Machbarkeit einer intravenösen Substitutionstherapie mit Hydagelan® (Hydromorphonhydrochlorid) in Wien

A.4.1

Sponsor's protocol code number

SHW01

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	Suchthilfe Wien gGmbH
B.1.3.4	Country	Austria
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	Suchthilfe Wien gGmbH
B.4.2	Country	Austria
B.4.1	Name of organisation providing support	G.L. Pharma GmbH
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	Suchthilfe Wien gGmbH
B.5.2	Functional name of contact point	Medical Director
B.5.3	Address:
B.5.3.1	Street Address	Gumpendorfer Gürtel 8
B.5.3.2	Town/ city	Vienna
B.5.3.3	Post code	1060
B.5.3.4	Country	Austria
B.5.4	Telephone number	00431400053603
B.5.5	Fax number	00431400053699
B.5.6	E-mail	hans.haltmayer@suchthilfe.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	Yes
D.2.1.1.1	Trade name	Hydagelan
D.2.1.1.2	Name of the Marketing Authorisation holder	G.L. Pharma GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Austria
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.3.4	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	Hydromorphone hydrochloride
D.3.9.1	CAS number	71-68-1
D.3.9.4	EV Substance Code	SUB02573MIG
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	10
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.IMP: 2
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	Hydagelan
D.2.1.1.2	Name of the Marketing Authorisation holder	G.L. Pharma GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Austria
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.3.4	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	Hydromorphone hydrochloride
D.3.9.1	CAS number	71-68-1
D.3.9.4	EV Substance Code	SUB02573MIG
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	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	No
D.IMP: 3
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	Hydagelan
D.2.1.1.2	Name of the Marketing Authorisation holder	G.L. Pharma GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Austria
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.3.4	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	Hydromorphone hydrochloride
D.3.9.1	CAS number	71-68-1
D.3.9.4	EV Substance Code	SUB02573MIG
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	50
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

Opioid dependence: Opioid dependence is a serious and usually chronic disease that requires treatment, encompasses various psychological and physical dimensions, and is associated with concomitant diseases and increased mortality.

Opioidabhängigkeit: Opioidabhängigkeit ist eine behandlungsbedürftige, schwere und meist
chronisch verlaufende Erkrankung, die verschiedene psychische und physische Dimensionen umfasst und mit Begleiterkrankungen sowie erhöhter Mortalität verbunden ist.

E.1.1.1

Medical condition in easily understood language

Opioid dependence is a severe and usually chronic disease requiring treatment.

Opioidabhängigkeit ist eine schwere und zumeist chronische und behandlungsbedürftige Erkrankung.

E.1.1.2

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.1
E.1.2	Level	LLT
E.1.2	Classification code	10013658
E.1.2	Term	Drug addiction
E.1.2	System Organ Class	100000004873

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 is to determine whether
- intravenous opioid agonist therapy with hydromorphone can be integrated into clinical practice and is safe in this therapeutic setting.
- to include further target groups that have not yet been reached or have been reached only poorly.
- the offer of intravenous OAT is accepted by patients and staff of the Suchthilfe Vienna gGmbH.
- the intravenous consumption of "illegal" opioids or opioid-containing medications prescribed for oral use is reduced.
- the general state of health (somatic/psychological) and the social situation stabilize.
- a decrease in delinquency is recorded.
- a higher retention rate in treatment can be achieved.

Primäre Studienziele: Es gilt zu überprüfen, ob
- eine intravenöse Opioid-Agonisten-Therapie mit Hydromorphon in den klinischen Alltag integriert werden kann und sicher ist.
- weitere, bislang nicht oder nur schlecht erreichte Zielgruppen inkludiert werden können.
- das Angebot der intravenösen OAT bei Patient*innen und Mitarbeiter*innen des Ambulatoriums Suchthilfe Wien Akzeptanz findet.
- der intravenöse Konsum „illegaler“ Opioide bzw. der zur oralen Einnahme verschriebenen opioidhaltigen Arzneispezialitäten reduziert wird.
- sich der allgemeine Gesundheitszustand (somatisch/psychisch) und die soziale Situation stabilisieren.
- ein Rückgang der Delinquenz zu verzeichnen ist.
- eine höhere Haltequote an die Behandlung erreicht werden kann.

E.2.2

Secondary objectives of the trial

The secondary objectives of the study are to develop a patient-centered care model and to further develop psychosocial services for this patient group.

Die sekundären Ziele der Studie bestehen in der Entwicklung eines patientenzentrierten Versorgungsmodells, sowie in der Weiter-entwicklung des psychosozialen Angebots für diese Patientengruppe.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Age between 18 and 75 years
- Opioid dependence according to ICD-10 diagnostic criteria.
- Patient has been on opioid agonist therapy (OAT) for at least one year; otherwise has been on intravenous opioid use for at least one year;
- Patients inject at least 5 times per week.
- Presence of a consumption pattern that corresponds with the opening hours of the Suchthilfe Wien
- Patient demonstrates willingness and ability to adhere to the planned study procedure and schedule.
- Signed patient information after informed consent has been given
- no planned vacations (more than 1 day per week), surgeries, hospital or prison stays within the next 14 weeks

- Alter zwischen 18 und 75 Jahre
- Opioidabhängigkeit gemäß den Diagnosekriterien von ICD-10
- Patient befindet sich seit mindestens einem Jahr in einer Opioid-Agonisten-Therapie (OAT); andernfalls besteht seit mindestens einem Jahr ein intravenöser Opioidkonsum;
- Patient injiziert zumindest 5 Mal pro Woche
- Vorliegen eines Konsumverhaltens, das mit den Öffnungszeiten des Ambulatoriums Suchthilfe Wien korrespondiert
- Patient zeigt die Bereitschaft und besitzt auch die Fähigkeit, sich an den geplanten Studienablauf und den Zeitplan zu halten
- Unterschriebene Patienteninformation nach erfolgter Aufklärung (Informed Consent)
- keine geplanten Urlaube (mehr als 1 Tag pro Woche), Operationen, Krankenhaus- oder Haftaufenthalte innerhalb der nächsten 14 Wochen

E.4

Principal exclusion criteria

- Diagnosis of severe medical or psychiatric illnesses
- Pregnancy
- Evidence of severe comorbidities with a predicted life expectancy of less than 12 months
- Hypersensitivity to hydromorphone or any of the following other ingredients: Sodium chloride, sodium citrate, citric acid monohydrate, water for injections.
- Presence of the following contraindications:
o severe respiratory depression with hypoxia or elevated carbon dioxide levels in the blood (hypercapnia).
o severe chronic obstructive airway disease
o Cor pulmonale
o Acute abdomen
o Paralytic ileus
o concomitant administration of monoaminooxidase inhibitors or within 2 weeks of their discontinuation

• Diagnose schwerer medizinischer oder psychiatrischer Erkrankungen
• Schwangerschaft
• Nachweis von schweren Begleiterkrankungen mit einer prognostizierten Lebenswartung von weniger als 12 Monaten
• Überempfindlichkeit gegen Hydromorphon oder einen der folgenden sonstigen Bestandteile: Natriumchlorid, Natriumcitrat, Citronensäure-Monohydrat, Wasser für Injektionszwecke
• Vorliegen von folgenden Gegenanzeigen:
o schwere Atemdepression mit Hypoxie oder erhöhten Kohlenstoffdioxidwerten im Blut (Hyperkapnie)
o schwere chronische obstruktive Atemwegserkrankung
o Cor pulmonale
o Akutes Abdomen
o Paralytischer Ileus
o gleichzeitige Gabe von Monoaminooxidasehemmern oder innerhalb von 2 Wochen nach deren Absetzen

E.5 End points

E.5.1

Primary end point(s)

Primary study endpoints
- Reduction of intravenous opioid use outside the medical setting.
- Feasibility of implementation and execution

Primäre Studienendpunkte
• Reduktion des intravenösen Opioidkonsums außerhalb des medizinischen Settings
• Machbarkeit der Implementierung und Durchführung

E.5.1.1

Timepoint(s) of evaluation of this end point

After 12 weeks of treatment

nach 12 Wochen Behandlung

E.5.2

Secondary end point(s)

Secondary study endpoints
- Reduction in co-drug use
- Safety of the intervention
- Improvement in health status
- Retention in treatment

Sekundäre Studienendpunkte
• Verringerung des Beikonsums
• Sicherheit der Intervention
• Verbesserung des Gesundheitszustandes
• Verbleib in der Behandlung

E.5.2.1

Timepoint(s) of evaluation of this end point

After 12 weeks of treatment

nach 12 Wochen Behandlung

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

E.6.5

Efficacy

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

Yes

E.6.13.1

Other scope of the trial description

Feasibility

Durchführbarkeit

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

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

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

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

At the end of the intervention phase it is ensured that the participants receive the best available and accepted treatment. 12 weeks after the end of the intervention phase the participants will be contacted by Suchthilfe Wien, with the aim of having them undergo a check-up at the Ambulatorium Suchthilfe Wien. The same basic examinations are carried out as at the beginning of the pre-study screening (except of the pregnancy test).

Am Ende der Interventionsphase wird sichergestellt, dass die Teilnehmer*innen die beste
verfügbare und akzeptierte Behandlung erhalten.
12 Wochen nach Ende der Interventionsphase werden die Teilnehmer*innen von der
Suchthilfe Wien kontaktiert, mit dem Ziel, dass sie sich einer Kontrolluntersuchung im
Ambulatorium Suchthilfe Wien unterziehen. Dabei werden dieselben Basisuntersuchungen
wie zu Beginn des Pre-Study Screenings durchgeführt (mit Ausnahme des
Schwangerschaftstests).

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

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

Yes

F.3.3.7.1

Details of other specific vulnerable populations

opioid dependent persons

opioidabhängige Personen

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)

At the end of the treatment, it is ensured that the participants receive the best available and accepted treatment.

Am Ende der Interventionsphase wird sichergestellt, dass die Teilnehmer*innen die beste verfügbare und akzeptierte Behandlung erhalten.

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

2022-12-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-11-30

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

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