An open-label extension study following the HRM4396B/3001 study (a double-blind, placebo-controlled, parallel arms, dose response study of two doses of HMR4396 versus placebo for anaemia in subjects treated with chemotherapy)
ISRCTN | ISRCTN41606826 |
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DOI | https://doi.org/10.1186/ISRCTN41606826 |
Secondary identifying numbers | HMR4396B/3002 |
- Submission date
- 12/06/2007
- Registration date
- 19/07/2007
- Last edited
- 15/08/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Chris Freitag
Scientific
Scientific
Shire contact for trial - no PI identified
Hampshire International Business Park
Lime Tree Way
Basingstoke
RG24 8EP
United Kingdom
Study information
Study design | Phase III, open-label extension study following the HMR4396B/3001 study |
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Primary study design | Interventional |
Secondary study design | Non randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | |
Study objectives | 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(s) | 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. |
Health condition(s) or problem(s) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Phase III |
Drug / device / biological / vaccine name(s) | HMR4396 |
Primary outcome measure | 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 study start date | 03/08/2000 |
Completion date | 16/09/2002 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | 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. |
Key inclusion criteria | 1. Completion of the HMR4396B/3001 study 2. Informed consent was obtained from all subjects before enrolment into the study |
Key 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 |
Date of first enrolment | 03/08/2000 |
Date of final enrolment | 16/09/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
- United States of America
Study participating centre
Shire contact for trial - no PI identified
Basingstoke
RG24 8EP
United Kingdom
RG24 8EP
United Kingdom
Sponsor information
Hoechst Marion Roussel (Shire Pharmaceuticals) (France)
Industry
Industry
102 Route de Noisy
Romainville, Cedex
93235
France
Website | http://www.shire.com/shire/ |
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https://ror.org/02n6c9837 |
Funders
Funder type
Industry
Hoechst Marion Roussel (Shire Pharmaceuticals) (France)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |