WHO ICTRP trial
A 12-Month Clinical Research Study to evaluate a new investigational medication…
EUCTR2020-000419-56-SE · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2020-000419-56-SE |
|---|---|
| Public title | A 12-Month Clinical Research Study to evaluate a new investigational medication (siplizumab) compared to another medication (anti-thymocyte globulin) for the prevention of rejection in patients who have received a kidney transplant. |
| Scientific title | A 12-month, randomized, controlled, open-label, dose escalation study evaluating safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of an anti-CD2 monoclonal antibody, TCD601 (siplizumab), compared to anti-thymocyte globulin (rATG), as induction therapy in de novo renal transplant… |
| Primary sponsor | ITB-MED 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 | Sweden |
| Conditions | renal transplantation MedDRA version: 21.1 Level: LLT Classification code 10050436 Term: Prophylaxis against renal transplant rejection System Organ Class: 100000004865 ;Therapeutic area: Body processes [G] - Immune system processes [G12] |
| Interventions | Product Name: siplizumab Product Code: TCD601 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: SIPLIZUMAB CAS Number: 288392-69-8 Current Sponsor code: TCD601 Other descriptive name: SIPLIZUMAB Concentration… |
| Registration date | Jul 12, 2020 |
| Target size | 40 |
| Secondary IDs | TCD601B101 |
| 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: