Clinical Trials Register

Summary
EudraCT Number:	2013-000949-39
Sponsor's Protocol Code Number:	802-247-09-033
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-08-14
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

Poland - Office for Medicinal Products

A.2

EudraCT number

2013-000949-39

A.3

Full title of the trial

An Observational Study Providing 12 Months of Safety Follow-Up from First Exposure to HP802-247 in Subjects Who Participated in Study 802-247-09-032(EU)

A.3.1

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

12 months study to observe safety of patients treated with HP802-247 in study 802-247-09-032(EU)

A.4.1

Sponsor's protocol code number

802-247-09-033

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	Smith & Nephew Inc.
B.1.3.4	Country	United States
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	Smith & Nephew Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Medpace GmbH
B.5.2	Functional name of contact point	Medpace Regulatory Submissions
B.5.3	Address:
B.5.3.1	Street Address	Theresienhöhe 30
B.5.3.2	Town/ city	Munich
B.5.3.3	Post code	80339
B.5.3.4	Country	Germany
B.5.4	Telephone number	+4989895571860
B.5.5	Fax number	+49898955718160
B.5.6	E-mail	regsubmissions@medpace.com

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.3.2	Product code	HP802-247
D.3.4	Pharmaceutical form	Cutaneous spray
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Keratinocytes
D.3.9.3	Other descriptive name	GROWTH-ARRESTED KERATINOCYTES
D.3.9.4	EV Substance Code	SUB120985
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.05 x 10^6 cells
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Fibroblasts
D.3.9.3	Other descriptive name	GROWTH-ARRESTED FIBROBLASTS
D.3.9.4	EV Substance Code	SUB120984
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.45 x 10^6 cells
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)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Yes
D.3.11.3.1	Somatic cell therapy medicinal product	Yes
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	Cutaneous spray, solution
D.8.4	Route of administration of the placebo	Cutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Chronic venous leg ulcer

E.1.1.1

Medical condition in easily understood language

Leg ulcer

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.1
E.1.2	Level	LLT
E.1.2	Classification code	10066677
E.1.2	Term	Chronic leg ulcer
E.1.2	System Organ Class	100000004858

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 assess new adverse events, and ongoing adverse events not resolved, in subjects who were exposed to a Investigational Medicinal Product (IMP) in the 802-247-09-032 trial.

E.2.2

Secondary objectives of the trial

Follow-up on the status of the target ulcer as open or closed.

Health Econimics
To determine if there are differences in Health related Quality of Life (HRQoL) associated with the treatment assignment from the 802 247-09-032 trial.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- The informed consent document must be read, signed, and dated by the subject or the subject’s legally authorized representative before conducting any study procedures or exams. A photocopy of the signed informed consent document must be provided to the subject, and the original signed document placed in the subject’s chart.
- Subject was randomized in 802-247-09-032 and received at least one application of test article.
- Subject has ended their participation in 802-247-09-032 by virtue of completing the study, or by dropping out prior to completion.

E.4

Principal exclusion criteria

Subjects who refuse to provide written informed consent for this study will be excluded from this study.

E.5 End points

E.5.1

Primary end point(s)

Efficacy
The persistence of target wound closure in subjects who achieved a “confirmed” complete wound closure over the treatment period of the preceding study. The persistence of wound closure will be measured by the proportion of subjects whose target wound remains closed at each follow-up visit.
Safety
- Length of the follow up
- Early Termination
- Adverse Events

E.5.1.1

Timepoint(s) of evaluation of this end point

visit 1, 2, 3, 4, 5, 6 (at an 8-weeks intervall)

E.5.2

Secondary end point(s)

Please Efficacy
- The proportion of subjects achieving target wound closure in this follow-up study who had not achieved a “confirmed” complete wound closure in study 802-247-09-032.
- The HRQoL measure of SPVU-5D total score will be compared for between-group differences at each follow-up visit by preceding treatment, using analysis of variance (ANOVA).enter information in English and add any other language that is applicable

E.5.2.1

Timepoint(s) of evaluation of this end point

visit 1, 2, 3, 4, 5, 6 (at an 8-weeks intervall)

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

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

Yes

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

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

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

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:

264

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

176

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

175

F.4.2

For a multinational trial

F.4.2.1

In the EEA

440

F.4.2.2

In the whole clinical trial

440

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

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

2013-10-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-08-07

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-11-20

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