WHO ICTRP trial
A study to investigate the safety and the effects of PBI-4050 when given to…
EUCTR2015-001625-16-GB · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2015-001625-16-GB |
|---|---|
| Public title | A study to investigate the safety and the effects of PBI-4050 when given to patients with the rare genetic disorder, Alström Syndrome |
| Scientific title | A Phase 2, Single-Arm, Open-Label Study to Evaluate the Safety and Tolerability of PBI-4050 and of its Effects on the Inflammatory, Fibrosis,Diabetes and Obesity Biomarkers in Subjects with Alström Syndrome - Phase II Study of PBI-4050 in Subjects with Alström Syndrome |
| Primary sponsor | ProMetic BioSciences Inc. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | United Kingdom |
| Conditions | Alström Syndrome MedDRA version: 19.1 Level: LLT Classification code 10068814 Term: Alstrom syndrome System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] |
| Interventions | Product Code: PBI-4050 Pharmaceutical Form: Capsule, soft INN or Proposed INN: 3-pentylbenzeneacetic acid sodium salt CAS Number: 1254472-97-3 Current Sponsor code: PBI-4050 Concentration unit: mg milligram(s) Concentration type: equal… |
| Registration date | Jan 9, 2015 |
| Target size | 18 |
| Secondary IDs | PBI-4050-ATX-9-05 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: