Anaemia Haematological Disorders Anaemia in chronic diseases classified elsewhere
Conditions
Interventions
The intervention was administration of HMR4396 at a starting dose of 150 U/kg three times weekly for 12 weeks. The dose could be increased to 300 U/kg after four weeks if the subjects haemoglobin was
Sponsors
Hoechst Marion Roussel (Shire Pharmaceuticals) (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Completion of the HMR4396B/3001 study 2. Informed consent was obtained from all subjects before enrolment into the study
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria were not to be included in the study: 1. Pregnant 2. Breast feeding 3. Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol 4. Current drug abuse 5. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoints in this study were: 1. Change in haemoglobin from baseline, and 2. The percentage of subjects receiving red blood cell transfusions during the study | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy endpoints were: 1. Number of red blood cell transfusions received during weeks 1 - 12 2. Number of units transfused during weeks 1 - 12 3. Change from baseline in haematocrit | — |
Countries
United States of America
Outcome results
None listed