E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy adult volunteers and burn patients 3 to 10 Days after the injury. |
Friska försökspersoner och brännskadade patienter 3 till 10 dagar efter skadan. |
|
E.1.1.1 | Medical condition in easily understood language |
Healthy individuals .
Burn patients 3 to 10 Days after the injury, when they still have an injury related inflammation. |
Friska försökspersoner
Brännskadade patienter 3 till 10 dagar efter skadan, när de fortfarande har en skaderelaterad ikropps inflammation. |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Physiological processes [G07] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To study if intravenously administered hyperoncotic albumin can attract fluid from the interstitium to the cirkulation in healthy individuals and in burn patients. |
Kan intravenöst givet albumin dra vätska från interstitiet till blodbanan hos friska och hos brännskadade patienter? |
|
E.2.2 | Secondary objectives of the trial |
Half-life of plasma volume expansion.
Plasma half-life of infused albumin |
Halveringstid för plasmavolymsexpansionen och halveringstid för den infunderade albumin mängden i plasma. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy volunteers
Burn patients 3 to 10 Days after the injury. |
Friska försökspersoner.
Brännskadade patienter 3 till 10 dagar efter skadan. |
|
E.4 | Principal exclusion criteria |
Patients with serious cardiac or pulmonary disease.
Health stats corresponding to American Society of Anesthesiologists (ASA) Group III and IV.
Inability to understand instructions.
Dementia. |
Patienter med svår hjärt- eller lungsjukdom.
Patienter som tillhör ASA klassifikationer II och IV.
Svårighet att förstå instruktioner.
Demens |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The data Collection is completed 4 hours after the 30-min infusion of albumin is initiated. |
Datainsamlingen avslutas 4 timmar efter det att 30 minutersinfusionen av albumin påbörjats. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
The study Always ends 4 hours after start of infusion. |
Studien slutar alltid 4 timmar efter infusionsstart. |
|
E.5.2 | Secondary end point(s) |
Collection of data for calculation of the duration of plasma volume expansion and the plasma half-life of albumin is ended at 4 hours after the infusion starts. |
Insamling av data avslutas 4 timmar efter att infusion av albumin påbörjats. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
At the end of the study 4 hours after infusion start. |
4 timmar efter infusionsstart. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
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
|
The trial will end if serious adverse effects appear. This is unlikely, as albumin 20% is used worlwide and is only known to be associated with low risk of allergic reactions. |
Studien avslutas om SAE uppträder. Detta är dock osannolikt, då albumin infusion används världsomspännande och den enda kända risken är en låg frekvens av allergiska reaktioner. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |