WHO ICTRP trial

A randomised controlled parallel group open-label study to evaluate the efficacy…

EUCTR2009-015766-56-FR · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2009-015766-56-FR
Public title A randomised controlled parallel group open-label study to evaluate the efficacy and safety of intravenous ferric carboxymaltose versus no treatment in anaemic subjects with multiple myeloma and iron-restricted erythropoiesis receiving chemotherapy
Scientific title A randomised controlled parallel group open-label study to evaluate the efficacy and safety of intravenous ferric carboxymaltose versus no treatment in anaemic subjects with multiple myeloma and iron-restricted erythropoiesis receiving chemotherapy
Primary sponsor Vifor Pharma 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): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries France;Greece;Germany
Conditions Treatment of anaemic subjects with multiple myeloma and iron restricted erythropoiesis receiving chemotherapy. MedDRA version: 12.0 Level: LLT Classification code 10028228 Term: Multiple myeloma MedDRA version: 12.0 Level: LLT…
Interventions Trade Name: Ferinject® Pharmaceutical Form: Intravenous infusion INN or Proposed INN: Ferric carboxymaltose (FCM) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50-
Registration date Oct 27, 2009
Target size 40
Secondary IDs FER-AOC-MM
Registry page clinicaltrialsregister.eu

At a glance

  • Yes Results available

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