Trial information
A Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Non-Myeloid Malignancy
Status: Completed
Protocol number: ML18183
Sponsor: Roche Pharma (Switzerland) AG
Company division: Pharmaceutical
Official Scientific Title: Open label, multicenter study to investigate the safety of once weekly Recormon therapy in anemic patients with non-myeloid malignancy.
Brief summary: This study will assess the safety of NeoRecormon in anemic patients with non-myeloid malignancy. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals. Target sample size is
15.
Study phase: III
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 endpoint: Adverse event rate and profile.
Key secondary outcomes: 1. Comparison of 3 different viral kinetic phases
Inclusion criteria:
- adult patients >=18 years of age;
- non-myeloid malignancy;
- anemia.
Exclusion criteria:
- transfusion of red blood cells within one month of study drug;
- treatment-resistant hypertension;
- acute or chronic bleeding (requiring therapy) within 3 months of study drug;
- anti-tumor therapy in the week before screening visit, apart from corticosteroids.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: December, 2004
Trial registration date: 03/30/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Switzerland
