Trial information
A Study of NeoRecormon (Epoetin Beta) in Patients With Refractory Anemia
Status: Completed
Protocol number: ML17850
Sponsor: Roche d.o.o.
Company division: Pharmaceutical
Official Scientific Title: An open-label study to investigate the safety of subcutaneous NeoRecormon therapy in patients with refractory anemia
Brief summary: This study will evaluate the safety of subcutaneous NeoRecormon in patients with refractory anemia, with or without ringed sideroblasts. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is
30.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety study
Condition: Anemia
Intervention type: Drug
Intervention name: epoetin beta[NeoRecormon]
Primary outcome: 1. Safety: Adverse event rate and profile
Key secondary outcomes: 1. Comparison of 3 different viral kinetic phases
Inclusion criteria:
- adult patients >=18 years of age;
- refractory anemia.
Exclusion criteria:
- previous unsuccessful treatment with epoetin;
- poorly-controlled hypertension;
- women who are pregnant or breastfeeding.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 10/28/2005
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Slovenia
- Celje
- Ljubljana
- Maribor
- Murska Sobota
