Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HMR4396B/3002
Study information
Scientific title
Acronym
Study hypothesis
Advanced cancer is frequently associated with significant anaemia. The causes of this anaemia are multi-factorial and may include the cytotoxic effects of chemotherapeutic agents on bone marrow.
Primary objective was to offer a 12-week open-label extension of treatment to subjects having completed the HMR4396B/3001 study in order to collect longer term safety and efficacy data in this population.
Ethics approval
This was a multi-national, multi-centre trial with 39 centres in the United States. The independent ethics committee from each of the sites approved the study before the first subject was enrolled.
Study design
Phase III, open-label extension study following the HMR4396B/3001 study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Anaemia
Intervention
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 less than or equal to 12 g/dL.
Quality of life was evaluated using the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire.
Intervention type
Drug
Phase
Phase III
Drug names
HMR4396
Primary outcome measures
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 outcome measures
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
Overall trial start date
03/08/2000
Overall trial end date
16/09/2002
Reason abandoned
Eligibility
Participant inclusion criteria
1. Completion of the HMR4396B/3001 study
2. Informed consent was obtained from all subjects before enrolment into the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
149 subjects enrolled into the study, of which 100 completed treatment with HMR4396. Nine subjects were enrolled but not treated with study medication, and 49 were withdrawn prior to study completion.
Participant 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
Recruitment start date
03/08/2000
Recruitment end date
16/09/2002
Locations
Countries of recruitment
United States of America
Trial participating centre
Shire contact for trial - no PI identified
Basingstoke
RG24 8EP
United Kingdom
Sponsor information
Organisation
Hoechst Marion Roussel (Shire Pharmaceuticals) (France)
Sponsor details
102 Route de Noisy
Romainville
Cedex
93235
France
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Hoechst Marion Roussel (Shire Pharmaceuticals) (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary