E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10024134 |
E.1.2 | Term | Leg ulcer (exc varicose) |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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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 |
The primary exploratory objective of this study is to observe the long-term (1 year) outcomes of Dermagraft, compared with conventional treatment of four-layer compression bandaging therapy alone, in subjects who completed ABH-DERMAGRAFT-001-08: a prospective, multi-center, randomized, controlled clinical investigation of Dermagraft in subjects with venous leg ulcers. |
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E.2.2 | Secondary objectives of the trial |
A secondary exploratory objective will be the incidence of complete study ulcer healing (defined as 100% epithelialization, with no evidence of drainage or scab) over the 1-year observational period for all study ulcers not healed at the time of study enrollment. Additional secondary measures will be the incidence of study ulcer infection-related events, time to study ulcer recurrence, change in ulcer size, and time to study ulcer healing. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Subject has completed ABH-DERMAGRAFT-001-08, up to and including the final visit, Visit #23 - Week 28, with the following exception: -If subject is part of the Control cohort, and the study ulcer under observation in ABH-DERMAGRAFT-001-08 is not healed at the Week 16 (Visit # 19) visit, the subject is eligible for inclusion into this long-term study as early as Week 20 (Visit #21). 2.Subject understands study requirements and is available to participate in the 1 year-long observational followup. This includes an ability to correspond with the site for follow-up information and a willingness to attend scheduled clinic visits and unscheduled clinic visits in the event of an ulcer recurrence or other Adverse Events. 3.Subject has read and signed the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form before screening procedures are undertaken. The informed consent will be used in each country and will include all the required elements. Each informed consent will be translated into all local languages for countries participating in the study and subjects will sign the informed consent in their own language.
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E.4 | Principal exclusion criteria |
1.Subjects who withdrew or were terminated from ABH-DERMAGRAFT-001-08 before Visit #23 – Week 28. Additionally, any subjects who are not available for the 1 year-long observational period in this study are excluded. 2.Subjects who are unable to understand the aims and objectives of the trial. 3.Subject has any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor compliance with medical treatment. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure will be the incidence of study ulcer recurrence (defined as a full-thickness skin ulcer, secondary to venous insufficiency, located in approximately the same anatomical location as the study ulcer that previously achieved complete re-epithelialization under treatment in ABH-DERMAGRAFT-001-08) during the 1-year observational period. This primary outcome will be evaluated only on subjects from each cohort who entered the 1-year follow-up period with a healed ulcer.
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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 | 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 | 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.8.3 |
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 | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
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 | 2 |
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 | 2 |
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 |