WHO ICTRP trial
Study to evaluate the efficacy and safety of deferasirox film-coated tablet…
EUCTR2016-002529-12-ES · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2016-002529-12-ES |
|---|---|
| Public title | Study to evaluate the efficacy and safety of deferasirox film-coated tablet versus phlebotomy in patients with HH |
| Scientific title | A phase II, multicenter, open-label, randomized two-year study to evaluate the efficacy and safety of deferasirox film-coated tablet versus phlebotomy in patients with Hereditary Hemochromatosis |
| Primary sponsor | Novartis Farmacéutica, S.A. |
| 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 | France;United States;Slovakia;Belgium;Spain;Romania;Turkey;Austria;Russian Federation;Bulgaria;Germany;Switzerland |
| Conditions | Hereditary Hemochromatosis MedDRA version: 20.0 Level: LLT Classification code 10057874 Term: Hereditary hemochromatosis System Organ Class: 100000012236 ;Therapeutic area: Diseases [C] - Eye Diseases [C11] |
| Interventions | Trade Name: Exjade Product Name: deferasirox Product Code: ICL670 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: DEFERASIROX CAS Number: 201530-41-8 Current Sponsor code: ICL670 Concentration unit: mg milligram(s)… |
| Registration date | Feb 8, 2017 |
| Target size | 150 |
| Secondary IDs | CICL670F2203 |
| 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: