Trial information
A Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Non-Myeloid Malignancy.
Status: No longer recruiting
Protocol number: ML18054
Sponsor: Roche Caracas
Company division: Pharmaceutical
Official Scientific Title: Open label , multicenter study to investigate the safety of once weekly Neorecormon therapy in anemic patients with non myeloid malignacy
Brief summary: This study will examine the efficacy, safety, and effect on hemoglobin levels, of once weekly NeoRecormon injections (30,000IU sc) in anemic patients with solid tumors. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 40.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Anemia
Intervention type: Device
Intervention name: epoetin beta[NeoRecormon]
Primary outcome: 1. Hemoglobin levels at 16 weeks; quality of life; tolerability.
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 2 months of study drug;
- treatment-resistant hypertension;
- acute or chronic bleeding (requiring therapy) within 3 months of study drug.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: April, 2006
Trial registration date: 07/19/2006
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Venezuela
