WHO ICTRP trial
Open-label, single-arm, multicenter study in Japanese patients with aplastic…
EUCTR2021-002155-11-Outside-EU/EEA · EU Clinical Trials Register
Key facts
| Trial ID | EUCTR2021-002155-11-Outside-EU/EEA |
|---|---|
| Public title | Open-label, single-arm, multicenter study in Japanese patients with aplastic anemia |
| Scientific title | A MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO ACCESS THE EFFICACY AND SAFETY OF PF-06462700 ADMINISTERED INTRAVENOUSLY AT 40 MG/KG/DAY FOR 4 DAYS IN JAPANESE PARTICIPANTS WITH MODERATE AND ABOVE APLASTIC ANEMIA |
| Primary sponsor | Pfizer Inc. |
| Registry | EU Clinical Trials Register |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Japan |
| Conditions | Moderate and above aplastic anemia;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] |
| Interventions | Trade Name: Atgam Product Name: Atgam Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Anti-human T-lymphocyte immunoglobulin from horse Other descriptive name: anti-human immunoglobulin, equine Concentration… |
| Registration date | Sep 6, 2021 |
| Secondary IDs | B5411003;NCT04350606 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No Results available
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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: