Clinical Trial Details
| Trial ID: | L4791 |
| Source ID: | NCT03111238 |
| Associated Drug: | Rex-001 |
| Title: | The Efficacy and Safety of REX-001 to Treat Ischemic Rest Pain in Subjects With CLI Rutherford Category 4 and DM |
| Acronym: | |
| Status: | TERMINATED |
| Study Results: | NO |
| Results: | |
| Conditions: | Peripheral Arterial Disease (PAD)|Diabetes Mellitus (DM)|Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2|Cardiovascular Disease|Critical Limb Ischemia (CLI) |
| Interventions: | DRUG: REX-001|DRUG: Placebo |
| Outcome Measures: | Primary: Complete relief of ischemic rest pain without developing ischemic lesions on the index leg., Change in Rutherford classification from CLI Category 4 to Category 3 or lower 12 months after administration of REX-001 or placebo., The primary endpoint for this trial will be assessed at 12 months. | |
| Sponsor/Collaborators: | Sponsor: Ixaka Ltd | Collaborators: Andalusian Network for Design and Translation of Advanced Therapies |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 3 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2017-04-05 |
| Completion Date: | 2021-03-31 |
| Results First Posted: | |
| Last Update Posted: | 2021-05-07 |
| Locations: | Fakultní nemocnice Ostrava, Ostrava, Czechia|Vitkovicka nemocnice a. s. Vaskularni centrum, Ostrava, Czechia|Klinikum der Goethe-Universität Frankfurt, Frankfurt, Germany|Pécsi Tudományegyetem, PTE-KK I. sz Belgyógyászati Klinika, Pécs, Hungary|Instytut Hematologii i Transfuzjologii, Warsaw, Poland|Centro Hospitalar de São João, Porto, Portugal|Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain|Hospital Universitari de Bellvitge, L'Hospitalet De Llobregat, Barcelona, Spain|Hospital Universitari Vall d'Hebron, Barcelona, Spain|Hospital Universitario Puerta del Mar, Cadiz, Spain|First site: Hospital Universitario Reina Sofía, Córdoba, Spain|Complejo Hospitalario Universitario de Granada, Hospital del Campus de la Salud, Granada, Spain|Hospital Universitario de la Princesa, Madrid, Spain|Hospital General Universitario Morales Meseguer, Murcia, Spain|Hospital Universitario Virgen de Valme, Sevilla, Spain |
| URL: | https://clinicaltrials.gov/show/NCT03111238 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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