- ICH GCP
- 欧盟临床试验注册处
临床试验Nct页
Summary | |
---|---|
EudraCT Number: | 2020-004933-19 |
Sponsor's Protocol Code Number: | DROPROP1 |
National Competent Authority: | Sweden - MPA |
Clinical Trial Type: | EEA CTA |
Trial Status: | |
Date on which this record was first entered in the EudraCT database: | 2021-01-25 |
Trial results |
A. Protocol Information | ||||
---|---|---|---|---|
A.1 | Member State Concerned | Sweden - MPA | ||
A.2 | EudraCT number | 2020-004933-19 | ||
A.3 | Full title of the trial |
| ||
A.3.1 | Title of the trial for lay people, in easily understood, i.e. non-technical, language |
| ||
A.3.2 | Name or abbreviated title of the trial where available |
| ||
A.4.1 | Sponsor's protocol code number | DROPROP1 | ||
A.7 | Trial is part of a Paediatric Investigation Plan | No | ||
A.8 | EMA Decision number of Paediatric Investigation Plan |
B. Sponsor Information | ||
---|---|---|
B.Sponsor: 1 | ||
B.1.1 | Name of Sponsor | Region Västra Götaland, Sahlgrenska Universitetssjukhuset |
B.1.3.4 | Country | Sweden |
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 | Region Västra Götaland, Sahlgrenska University Hospital |
B.4.2 | Country | Sweden |
B.5 Contact point designated by the sponsor for further information on the trial | ||
B.5.1 | Name of organisation | The Sahlgrenska Center for Pediatric Ophthalmology Research |
B.5.2 | Functional name of contact point | Carola Pfeiffer Mosesson |
B.5.3 | Address: | |
B.5.3.1 | Street Address | Vitaminvägen 21 |
B.5.3.2 | Town/ city | Gothenburg |
B.5.3.3 | Post code | 41650 |
B.5.3.4 | Country | Sweden |
B.5.4 | Telephone number | +46709126127 |
B.5.5 | Fax number | +4631848952 |
B.5.6 | carola.pfeiffer-mosesson@gu.se |
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 | Dexafree |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Laboratoires THEA 12, rue Louis Blériot 63017 Clermont-Ferrand Cedex 2 Frankrike |
D.2.1.2 | Country which granted the Marketing Authorisation | Sweden |
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.3.1 | Product name | Dexafree |
D.3.4 | Pharmaceutical form | Eye drops |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Ocular use |
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 | Eye drops |
D.8.4 | Route of administration of the placebo | Ocular use |
E. General Information on the Trial | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
E.1 Medical condition or disease under investigation | |||||||||||||||||
E.1.1 | Medical condition(s) being investigated |
| |||||||||||||||
E.1.1.1 | Medical condition in easily understood language |
| |||||||||||||||
E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] | |||||||||||||||
MedDRA Classification | |||||||||||||||||
E.1.2 Medical condition or disease under investigation | |||||||||||||||||
| |||||||||||||||||
E.1.3 | Condition being studied is a rare disease | Yes | |||||||||||||||
E.2 Objective of the trial | |||||||||||||||||
E.2.1 | Main objective of the trial |
| |||||||||||||||
E.2.2 | Secondary objectives of the trial |
| |||||||||||||||
E.2.3 | Trial contains a sub-study | No | |||||||||||||||
E.3 | Principal inclusion criteria |
| |||||||||||||||
E.4 | Principal exclusion criteria |
| |||||||||||||||
E.5 End points | |||||||||||||||||
E.5.1 | Primary end point(s) |
| |||||||||||||||
E.5.1.1 | Timepoint(s) of evaluation of this end point |
| |||||||||||||||
E.5.2 | Secondary end point(s) |
| |||||||||||||||
E.5.2.1 | Timepoint(s) of evaluation of this end point |
| |||||||||||||||
E.6 and E.7 Scope of the trial | |||||||||||||||||
E.6 | Scope of the trial | ||||||||||||||||
E.6.1 | Diagnosis | No | |||||||||||||||
E.6.2 | Prophylaxis | Yes | |||||||||||||||
E.6.3 | Therapy | Yes | |||||||||||||||
E.6.4 | Safety | No | |||||||||||||||
E.6.5 | Efficacy | No | |||||||||||||||
E.6.6 | Pharmacokinetic | No | |||||||||||||||
E.6.7 | Pharmacodynamic | No | |||||||||||||||
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) | Yes | |||||||||||||||
E.7.4 | Therapeutic use (Phase IV) | No | |||||||||||||||
E.8 Design of the trial | |||||||||||||||||
E.8.1 | Controlled | Yes | |||||||||||||||
E.8.1.1 | Randomised | Yes | |||||||||||||||
E.8.1.2 | Open | No | |||||||||||||||
E.8.1.3 | Single blind | Yes | |||||||||||||||
E.8.1.4 | Double blind | No | |||||||||||||||
E.8.1.5 | Parallel group | Yes | |||||||||||||||
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 | Yes | |||||||||||||||
E.8.2.3 | Other | No | |||||||||||||||
E.8.2.4 | Number of treatment arms in the trial | 2 | |||||||||||||||
E.8.3 | The trial involves single site in the Member State concerned | No | |||||||||||||||
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 | 11 | |||||||||||||||
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 | Yes | |||||||||||||||
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 |
| |||||||||||||||
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 | 0 | |||||||||||||||
E.8.9.1 | In the Member State concerned days | 0 |
F. Population of Trial Subjects | ||||
---|---|---|---|---|
F.1 Age Range | ||||
F.1.1 | Trial has subjects under 18 | Yes | ||
F.1.1 | Number of subjects for this age range: | 100 | ||
F.1.1.1 | In Utero | No | ||
F.1.1.2 | Preterm newborn infants (up to gestational age < 37 weeks) | Yes | ||
F.1.1.2.1 | Number of subjects for this age range: | 100 | ||
F.1.1.3 | Newborns (0-27 days) | No | ||
F.1.1.4 | Infants and toddlers (28 days-23 months) | Yes | ||
F.1.1.4.1 | Number of subjects for this age range: | 100 | ||
F.1.1.5 | Children (2-11years) | No | ||
F.1.1.6 | Adolescents (12-17 years) | No | ||
F.1.2 | Adults (18-64 years) | No | ||
F.1.3 | Elderly (>=65 years) | No | ||
F.2 Gender | ||||
F.2.1 | Female | Yes | ||
F.2.2 | Male | Yes | ||
F.3 Group of trial subjects | ||||
F.3.1 | Healthy volunteers | No | ||
F.3.2 | Patients | Yes | ||
F.3.3 | Specific vulnerable populations | Yes | ||
F.3.3.1 | Women of childbearing potential not using contraception | No | ||
F.3.3.2 | Women of child-bearing potential using contraception | No | ||
F.3.3.3 | Pregnant women | No | ||
F.3.3.4 | Nursing women | No | ||
F.3.3.5 | Emergency situation | No | ||
F.3.3.6 | Subjects incapable of giving consent personally | Yes | ||
F.3.3.6.1 | Details of subjects incapable of giving consent |
| ||
F.3.3.7 | Others | Yes | ||
F.3.3.7.1 | Details of other specific vulnerable populations |
| ||
F.4 Planned number of subjects to be included | ||||
F.4.1 | In the member state | 90 | ||
F.4.2 | For a multinational trial | |||
F.4.2.2 | In the whole clinical trial | 90 | ||
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) |
|
G. Investigator Networks to be involved in the Trial | ||
---|---|---|
G.4 Investigator Network to be involved in the Trial: 1 | ||
G.4.1 | Name of Organisation | Region Skåne University Hospital, Lund |
G.4.3.4 | Network Country | Sweden |
G.4 Investigator Network to be involved in the Trial: 2 | ||
G.4.1 | Name of Organisation | Region Jönköpings län, Ryhovs sjukhus Jönköping |
G.4.3.4 | Network Country | Sweden |
G.4 Investigator Network to be involved in the Trial: 3 | ||
G.4.1 | Name of Organisation | Region Västra Götaland Skaraborgs Sjukhus, Skövde |
G.4.3.4 | Network Country | Sweden |
G.4 Investigator Network to be involved in the Trial: 4 | ||
G.4.1 | Name of Organisation | Region Uppsala Akademiska Sjukhuset, Neuro sektion ögon |
G.4.3.4 | Network Country | Sweden |
G.4 Investigator Network to be involved in the Trial: 5 | ||
G.4.1 | Name of Organisation | Norrlands Universitetssjukhus |
G.4.3.4 | Network Country | Sweden |
G.4 Investigator Network to be involved in the Trial: 6 | ||
G.4.1 | Name of Organisation | St Eriks Ögonsjukvård |
G.4.3.4 | Network Country | Sweden |
G.4 Investigator Network to be involved in the Trial: 7 | ||
G.4.1 | Name of Organisation | Universitetssjukhuset Linköping |
G.4.3.4 | Network Country | Sweden |
G.4 Investigator Network to be involved in the Trial: 8 | ||
G.4.1 | Name of Organisation | Gävle Sjukhus |
G.4.3.4 | Network Country | Sweden |
G.4 Investigator Network to be involved in the Trial: 9 | ||
G.4.1 | Name of Organisation | Centralsjukhuset Karlstad |
G.4.3.4 | Network Country | Sweden |
G.4 Investigator Network to be involved in the Trial: 10 | ||
G.4.1 | Name of Organisation | Västmanlands sjukhus |
G.4.3.4 | Network Country | Sweden |
N. Review by the Competent Authority or Ethics Committee in the country concerned | ||
---|---|---|
N. | Competent Authority Decision | Authorised |
N. | Date of Competent Authority Decision | 2021-03-11 |
N. | Ethics Committee Opinion of the trial application | |
N. | Ethics Committee Opinion: Reason(s) for unfavourable opinion | |
N. | Date of Ethics Committee Opinion |