Kliniske forsøg Nct side
| Summary | |
|---|---|
| EudraCT Number: | 2005-002385-11 |
| Sponsor's Protocol Code Number: | BIG01−01/BO16348B |
| National Competent Authority: | Italy - Italian Medicines Agency |
| Clinical Trial Type: | EEA CTA |
| Trial Status: | Completed |
| Date on which this record was first entered in the EudraCT database: | 2018-03-07 |
| Trial results | |
| A. Protocol Information | ||||
|---|---|---|---|---|
| A.1 | Member State Concerned | Italy - Italian Medicines Agency | ||
| A.2 | EudraCT number | 2005-002385-11 | ||
| A.3 | Full title of the trial |
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| A.3.1 | Title of the trial for lay people, in easily understood, i.e. non-technical, language |
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| A.3.2 | Name or abbreviated title of the trial where available |
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| A.4.1 | Sponsor's protocol code number | BIG01−01/BO16348B | ||
| 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 | F. HOFFMANN - LA ROCHE LTD. |
| B.1.3.4 | Country | Switzerland |
| 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 | F. Hoffmann - La Roche |
| B.4.2 | Country | Switzerland |
| B.5 Contact point designated by the sponsor for further information on the trial | ||
| B.5.1 | Name of organisation | Roche SpA |
| B.5.2 | Functional name of contact point | - |
| B.5.3 | Address: | |
| B.5.3.1 | Street Address | viale Stucchi |
| B.5.3.2 | Town/ city | Monza |
| B.5.3.3 | Post code | - |
| B.5.3.4 | Country | Italy |
| B.5.4 | Telephone number | 0 |
| B.5.5 | Fax number | 0 |
| B.5.6 | nd@nd.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.3.1 | Product name | - |
| D.3.4 | Pharmaceutical form | Emulsion for infusion |
| D.3.4.1 | Specific paediatric formulation | No |
| D.3.7 | Routes of administration for this IMP | |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.9.2 | Current sponsor code | 0 |
| 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 | 0 |
| 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) | No |
| D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
| D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
| D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
| D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
| D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
| 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 |
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| E. General Information on the Trial | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| E.1 Medical condition or disease under investigation | |||||||||||||||||
| E.1.1 | Medical condition(s) being investigated |
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| E.1.1.1 | Medical condition in easily understood language |
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| E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] | |||||||||||||||
| MedDRA Classification | |||||||||||||||||
| E.1.2 Medical condition or disease under investigation | |||||||||||||||||
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| 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 |
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| E.2.2 | Secondary objectives of the trial |
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| E.2.3 | Trial contains a sub-study | No | |||||||||||||||
| E.3 | Principal inclusion criteria |
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| E.4 | Principal exclusion criteria |
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| E.5 End points | |||||||||||||||||
| E.5.1 | Primary end point(s) |
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
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| E.5.2 | Secondary end point(s) |
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
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| 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 | 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 | Yes | |||||||||||||||
| E.8.1.3 | Single blind | No | |||||||||||||||
| 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 | No | |||||||||||||||
| E.8.2.3 | Other | Yes | |||||||||||||||
| E.8.2.3.1 | Comparator description |
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| E.8.2.4 | Number of treatment arms in the trial | 0 | |||||||||||||||
| 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.8.4.1 | Number of sites anticipated in Member State concerned | 1 | |||||||||||||||
| E.8.5 | The trial involves multiple Member States | No | |||||||||||||||
| E.8.5.1 | Number of sites anticipated in the EEA | 0 | |||||||||||||||
| E.8.6 Trial involving sites outside the EEA | |||||||||||||||||
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes | |||||||||||||||
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT | |||||||||||||||
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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| 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 |
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| E.8.9 Initial estimate of the duration of the trial | |||||||||||||||||
| E.8.9.1 | In the Member State concerned years | 8 | |||||||||||||||
| E.8.9.1 | In the Member State concerned months | 0 | |||||||||||||||
| E.8.9.1 | In the Member State concerned days | 0 | |||||||||||||||
| E.8.9.2 | In all countries concerned by the trial years | 8 | |||||||||||||||
| E.8.9.2 | In all countries concerned by the trial months | 0 | |||||||||||||||
| E.8.9.2 | In all countries concerned by the trial days | 0 | |||||||||||||||
| F. Population of Trial Subjects | ||||
|---|---|---|---|---|
| F.1 Age Range | ||||
| F.1.1 | Trial has subjects under 18 | No | ||
| F.1.1 | Number of subjects for this age range: | 1 | ||
| F.1.1.1 | In Utero | Information not present in EudraCT | ||
| F.1.1.2 | Preterm newborn infants (up to gestational age < 37 weeks) | Information not present in EudraCT | ||
| F.1.1.3 | Newborns (0-27 days) | Information not present in EudraCT | ||
| F.1.1.4 | Infants and toddlers (28 days-23 months) | Information not present in EudraCT | ||
| F.1.1.5 | Children (2-11years) | Information not present in EudraCT | ||
| F.1.1.6 | Adolescents (12-17 years) | Information not present in EudraCT | ||
| F.1.2 | Adults (18-64 years) | Yes | ||
| F.1.2.1 | Number of subjects for this age range: | 0 | ||
| F.1.3 | Elderly (>=65 years) | Yes | ||
| F.1.3.1 | Number of subjects for this age range: | 0 | ||
| F.2 Gender | ||||
| F.2.1 | Female | Yes | ||
| F.2.2 | Male | No | ||
| F.3 Group of trial subjects | ||||
| F.3.1 | Healthy volunteers | No | ||
| F.3.2 | Patients | Yes | ||
| F.3.3 | Specific vulnerable populations | No | ||
| F.3.3.1 | Women of childbearing potential not using contraception | Information not present in EudraCT | ||
| F.3.3.2 | Women of child-bearing potential using contraception | Information not present in EudraCT | ||
| F.3.3.3 | Pregnant women | Information not present in EudraCT | ||
| F.3.3.4 | Nursing women | Information not present in EudraCT | ||
| F.3.3.5 | Emergency situation | Information not present in EudraCT | ||
| F.3.3.6 | Subjects incapable of giving consent personally | Information not present in EudraCT | ||
| F.3.3.7 | Others | Information not present in EudraCT | ||
| F.4 Planned number of subjects to be included | ||||
| F.4.1 | In the member state | 479 | ||
| F.4.2 | For a multinational trial | |||
| F.4.2.1 | In the EEA | 479 | ||
| F.4.2.2 | In the whole clinical trial | 480 | ||
| 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) |
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| G. Investigator Networks to be involved in the Trial |
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| N. Review by the Competent Authority or Ethics Committee in the country concerned | ||
|---|---|---|
| N. | Competent Authority Decision | Authorised |
| N. | Date of Competent Authority Decision | 2002-05-16 |
| N. | Ethics Committee Opinion of the trial application | Favourable |
| N. | Ethics Committee Opinion: Reason(s) for unfavourable opinion | |
| N. | Date of Ethics Committee Opinion | 2002-03-12 |
| P. End of Trial | ||
|---|---|---|
| P. | End of Trial Status | Completed |