An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)

• Status: Completed
• Trial end date: 2018-06-12
• Target enrollment: 0
• Participant gender: All

Summary

Evaluate safety and efficacy of intravenous (IV) iron isomaltoside/ferric derisomaltose re-dosing, in subjects who were previously treated with iron isomaltoside/ferric derisomaltose.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmacosmos A/S
• Treatments: Iron; Iron isomaltoside 1000

Criteria

Inclusion Criteria:

1. Completed one of the lead-in trials

2. Randomised and dosed with iron isomaltoside/ferric derisomaltose in one of the lead-in trials.

3. Haemoglobin (Hb) of ≤ 11 g/dL

4. Screening serum ferritin (s-ferritin) ≤ 100 ng/mL, or ≤ 300 ng/mL if transferrin saturation (TSAT) ≤ 30 %

5. Willingness to participate and signing the informed consent form (ICF)

Exclusion Criteria:

1. Intravenous (IV) iron treatment between the lead-in trial and screening

2. During 30-day period prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy

3. Received an investigational drug within 30 days of screening

4. Decompensated liver cirrhosis or active hepatitis

5. Pregnant or nursing women.

6. Any other laboratory abnormality, medical condition, or psychiatric disorders which, in the opinion of the Investigator, will put the subject's disease management at risk or may result in the subject being unable to comply with the trial requirements