Clinical Trials Register

Summary
EudraCT Number:	2013-003652-20
Sponsor's Protocol Code Number:	Ptcl-01501
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2013-09-23
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

Czechia - SUKL

A.2

EudraCT number

2013-003652-20

A.3

Full title of the trial

Pilot trial of intravenous DP-b99 in the treatment of first-ever episode of non-obstructive acute high-risk pancreatitis

Pilotní studie intravenózního podání DP-b99 při léčbě vůbec první epizody
neobstrukční vysoce rizikové akutní pankreatitidy

A.3.1

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

Small scale preliminary clinical study on the intravenous administration of DP-b99 in the treatment of acute high-risk inflammation of the pancreas that occurs for the first time in the patient and is not due to obstruction of the main pancreatic duct

Předběžné klinické hodnocení malého rozsahu zameřené na nitrožilní
podání DP-B99 při léčbě akutního vysoce rizikového zánětu slinivky břišní,
který se vyskytune u pacienta vůbec poprvé a není způsoben ucpáním
hlavního vývodu pankreatu

A.4.1

Sponsor's protocol code number

Ptcl-01501

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	D-Pharm Ltd.
B.1.3.4	Country	Israel
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	D-Pharm Ltd.
B.4.2	Country	Israel
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	FGK Clinical Research s.r.o.
B.5.2	Functional name of contact point	Project management
B.5.3	Address:
B.5.3.1	Street Address	Polská 1283/18
B.5.3.2	Town/ city	Prague 2
B.5.3.3	Post code	12000
B.5.3.4	Country	Czech Republic
B.5.4	Telephone number	+420222 233904
B.5.5	Fax number	+420222 212106

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	DP-b99
D.3.4	Pharmaceutical form	Lyophilisate for solution for 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.3.9.1	CAS number	222315-66-4
D.3.9.2	Current sponsor code	DP-b99
D.3.9.3	Other descriptive name	Chemical name: 1,2-Bis(2-aminophenoxy)ethane- N,N,N'N'- tetraacetic acid, N,N'- di(octyloxyethyl ester), N,N'-disodium salt
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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	Lyophilisate for solution for 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

Acute pancreatitis

E.1.1.1

Medical condition in easily understood language

Acute infection of the pancreas

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.0
E.1.2	Level	LLT
E.1.2	Classification code	10000971
E.1.2	Term	Acute pancreatitis
E.1.2	System Organ Class	100000004856

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Effects of DP-b99 in subjects with high risk acute pancreatitis on systemic inflammation.

E.2.2

Secondary objectives of the trial

Effects of DP-b99 in subjects with high risk acute pancreatitis on
• Safety
• Early clinical outcome (preliminary data)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Male or female subject.
• Age 18 years or higher.
• First in a lifetime episode of acute pancreatitis.
• Diagnosis of acute pancreatitis based on 2 of the following 3 criteria:
- Typical upper abdominal pain.
- Elevation of serum amylase and/or lipase 3 times the upper limit of normal.
- Contrast-material enhanced CT scan or abdominal sonogram demonstrating changes of acute pancreatitis.
• History supporting alcoholic, hypertriglyceridemic or biliary etiology of the current pancreatitis episode (for biliary pancreatitis, a sonogram must exclude a stone obstruction at the time of study screening).
• BISAP score >= 3.
• Study treatment initiation is possible within 48 h of symptom onset.
• Ability to provide informed consent.

E.4

Principal exclusion criteria

• Drug-induced, viral, hereditary or post-ERCP pancreatitis.
• Recurrent episode of pancreatitis.
• CT evidence of pancreatic necrosis at study entry.
• Imaging evidence of physical obstruction of the common bile duct at study entry; e.g. for abdominal sonogram, stone(s) in the common bile duct or common bile duct having diameter > 6 mm (above 80 years, > 8 mm) with gallbladder in situ.
• Severe chronic renal failure (Modification of Diet in Renal Disease formula <= 30mL/min or dependency on renal dialysis).
• High likelihood for an invasive intra-biliary tract intervention (e.g. ERCP) in the coming week.
• Class II or greater NYHA heart failure.
• Oxygen-dependent chronic obstructive pulmonary disease (COPD).
• Cirrhosis of the liver.
• Severe anemia (hemoglobin < 8 g/dL).
• Hematocrit < 35% or > 45% at study entry (fluids may be administered to correct the hematocrit before randomisation as long as study treatment starts within 48 hours of symptoms onset).
• Serum ALT >250 IU/L at study entry.
• Clinical suspicion of ascending cholangitis at study entry.
• Active gastrointestinal bleeding.
• Current malignancy not in remission (other than basal cell carcinoma of skin).
• Altered mental status.
• Current breast feeding or pregnancy.
• Female of childbearing potential (< 2 years postmenopausal or not surgically sterilized) who is not willing to use adequate and effective birth control measures (failure rate less than 1% per year when used consistently and correctly (e.g., implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner)) for the duration of the trial.
• Known hypersensitivity to any component of the investigational product.
• Dependent relationship with the investigator or the sponsor.
• Participation in an investigational drug study during this clinical trial or within 30 days prior to start of this study.

E.5 End points

E.5.1

Primary end point(s)

The primary study endpoint is to assess the effect of DP-b99 on systemic inflammation in acute pancreatitis as reflected by C-reactive protein (CRP) plasma levels.

E.5.1.1

Timepoint(s) of evaluation of this end point

Days 0, 1, 2, 3, 4, 5, 6

E.5.2

Secondary end point(s)

• Pharmacodynamics (PD)
(1) Plasma concentrations of TNF-alpha, IL-6, MMP-9.

• Safety
(2) Physical examination, (3) Vital signs (heart rate, systolic/diastolic blood pressure, body temperature, respiratory rate), (4) 12-lead ECG, (5) Adverse events, (6) Safety laboratory test (clinical chemistry, hematology, urinalysis).

• Clinical
(7) Systemic inflammatory response syndrome (SIRS) score, (8) Acute Physiology and Chronic Health Evaluation II (APACHE II) score, (9) AUCD0-6 for the SIRS score, (10) death or persistent single- or multiple-organ failure, (11) characteristics of pancreas morphology in abdominal CT.

• Pharmacokinetics (PK)
(12) Plasma concentrations of DP d99.

E.5.2.1

Timepoint(s) of evaluation of this end point

1: Days 0, 1, 2, 3, 4, 5, 6

2: Days 0, 1, 2, 3, 4, 5, 6, 14

3, Vital signs – heart rate, systolic/diastolic blood pressure: Day 0, day 1 (12 h and 24 h), day 2 (36 h and 48 h), days 3 to 6

3, Vital signs – body temperature: Days 0, 1, 2, 3, 4, 5, 6, 14

4: Day 0, day 1 (12 h and 24 h), day 2 (36 h and 48 h), days 3 to 6

5: Day 1 (12 h and 24 h), day 2 (36 h and 48 h), days 3 to 6, day 14

6: Days 0, 1, 2, 3, 4, 5, 6, 14

7: Days 0, 1, 2, 3, 4, 5, 6

8: Days 0, 1, 2

9: Days 0 to 6

10: Day 0, day 1 (12 h and 24 h), day 2 (36 h and 48 h), days 3 to 6, day 14

11: Day 0 (at the investigator’s discretion), day 3

12:Day 1 (12 h and 24 h), day 2 (36 h and 48 h)

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

Yes

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

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

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:

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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 continue to receive standard of care treatment for the medical condition under investigation.

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

2013-12-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-11-11

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2015-05-31

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