Clinical Trial Page

Summary
EudraCT Number:2004-001551-11
Sponsor's Protocol Code Number:Iloprost
National Competent Authority:Sweden - MPA
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2004-08-13
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
A. Protocol Information
A.1Member State ConcernedSweden - MPA
A.2EudraCT number2004-001551-11
A.3Full title of the trial
Behandling av förhöjt pulmonellt arteriellt tryck med inhalerad iloprost
A.3.2Name or abbreviated title of the trial where available
Iloprost
A.4.1Sponsor's protocol code numberIloprost
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorLund University Hospital
B.1.3.4CountrySweden
B.3.1 and B.3.2Status of the sponsorNon-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
D.2.1.1.1Trade name Ventavis ®
D.2.1.1.2Name of the Marketing Authorisation holderSchering Nordiska AB
D.2.1.2Country which granted the Marketing AuthorisationSweden
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameVentavis
D.3.2Product code B01AC
D.3.4Pharmaceutical form Inhalation vapour, solution
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPInhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNIloprost
D.3.10 Strength
D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number10
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product Information not present in EudraCT
D.8 Information on Placebo
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Nyfödda barn som är i behov av respiratorvård pga RDS, mekoniumaspiration eller primär lunghypertension
MedDRA Classification
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
Studien eftersträvar att utvärdera iloprostets effekt på respiratorisk, cardiovaskulär och cerebral funktion.

Primär målsättning:

Att utvärdera effekten av inhalerad iloprost på höger och vänster cardiac output samt koronarkärlsflöde.
E.2.2Secondary objectives of the trial
1. Att relatera effekten av inhalerad iloprost till proinflammatoriska cytokinnivåer i tidigt ventrikelaspirat, trakealsekret samt i cirkulationen.

2. Att utvärdera effekten av inhalerad iloprost på arteriellt blodtryck, cerebralt blodflöde, syrgasleverans och oxygenextraktion.

3. Att utvärdera effekten av inhalerad iloprost på kvantifierad spektral frekvens uppmätt med amplitudintegrerat EEG.

Sekundära utfallsparametrar
- Trycket i lungcirkulationen
- Hjärtats kontraktilitet
- Kranskärlsflödet
- Blodflödet i hjärnan
- Amplitudintegrerat EEG (aEEG)
- Längd av respiratorbehandling
- Syrgasbehov vid 36 GV
- Lungröntgen fynd i 3 dagars och 36 gv ålder


E.2.3Trial contains a sub-study Information not present in EudraCT
E.3Principal inclusion criteria
Inklusionskriterier:

- Respiratorvård pga RDS, mekoniumaspiration eller primär lunghypertension.
- Gestationsålder 24 veckor eller mera
- Postnatal ålder 0-24 t (- 48 t) timmar
- Föräldrarnas tillstånd
- Inga betydande anomalier
E.4Principal exclusion criteria
Exklusionskriterier:

- Betydande anomalier
- Ålder över 48 timmar
- Patienten är redan inkluderad i en pågående studie vid namn ”IGF-studie”
E.5 End points
E.5.1Primary end point(s)
Primära utfallsparametrar

- Cardiac output
- Oxygeneringsindex
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy Yes
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Yes
E.6.7Pharmacodynamic Yes
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic Information not present in EudraCT
E.6.11Pharmacogenomic Yes
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) Yes
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled No
E.8.1.1Randomised No
E.8.1.2Open Information not present in EudraCT
E.8.1.3Single blind Information not present in EudraCT
E.8.1.4Double blind Information not present in EudraCT
E.8.1.5Parallel group Information not present in EudraCT
E.8.1.6Cross over Information not present in EudraCT
E.8.1.7Other Information not present in EudraCT
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo No
E.8.2.3Other No
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 No
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.7Trial has a data monitoring committee Information not present in EudraCT
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
Studien avslutas efter att den sista patienten har genomgått uppföljningsundersökning

Utfallsparametrarna utvärderas i en pilot om 10 patienter som uppfyller inklusionskriterierna. På basen av denna pilot beslutas det definitiva antalet patienter (30-40 st). Rekrytering per år: 25-30 barn.

E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years7
E.8.9.1In the Member State concerned months
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial years7
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 Yes
F.1.1.1In Utero Information not present in EudraCT
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
F.1.1.3Newborns (0-27 days) Yes
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) No
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) No
F.1.3Elderly (>=65 years) No
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Information not present in EudraCT
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally Yes
F.3.3.6.1Details of subjects incapable of giving consent
Nyfödda barn, för vilka informerat föräldramedgivande inhämtas
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state40
F.4.2 For a multinational trial
F.4.2.1In the EEA 40
F.4.2.2In the whole clinical trial 40
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)
Iloprost-behandlingen fortsätter så länge respiratorvården pågår, men högst i 7 dygn. Om klar PPHN (persisterande pulmonellt tryck) är diagnostiserad (definierat som pulmonaltryck lika som eller högre än systemtrycket) och ingen effekt observerats på arteriell syremättnad inom 1 timme efter iloprostinhalation ges inhalerad kväveoxid (iNO) enligt standardrutiner.
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2004-09-22
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2004-09-02
P. End of Trial
P.End of Trial StatusOngoing

Sponsors and Collaborators

Medical Conditions

Drug Interventions

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