WHO ICTRP trial
Clinical trial of a single dose of treprostinil injected as a depot under the…
EUCTR2019-002444-24-GB · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2019-002444-24-GB |
|---|---|
| Public title | Clinical trial of a single dose of treprostinil injected as a depot under the skin to investigate the effect on the digital blood flow and safety in patients with Raynaud’s Phenomenon due to Systemic Sclerosis |
| Scientific title | An Exploratory Trial Assessing Vascular Digital Perfusion, Pharmacokinetics, Safety and Tolerability Following a Single Dose of CAM2043 (Treprostinil Subcutaneous Depot) in Patients with Raynaud’s Phenomenon Secondary to Systemic Sclerosis |
| Primary sponsor | Camurus AB |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| 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 | Raynaud’s phenomenon secondary to systemic sclerosis MedDRA version: 20.0 Level: PT Classification code 10037912 Term: Raynaud's phenomenon System Organ Class: 10047065 - Vascular disorders ;Therapeutic area: Diseases [C] - Musculoskeletal… |
| Interventions | Product Name: CAM2043 Product Code: CAM2043 Pharmaceutical Form: Prolonged-release solution for injection INN or Proposed INN: Treprostinil Sodium CAS Number: 289480-64-4 Current Sponsor code: CAM2043 Other descriptive name: TREPROSTINIL… |
| Registration date | Dec 18, 2019 |
| Target size | 12 |
| Secondary IDs | HS-18-638 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No Results available
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: