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
DOI	https://doi.org/10.1186/ISRCTN41606826
Protocol serial number	HMR4396B/3002
Sponsor	Hoechst Marion Roussel (Shire Pharmaceuticals) (France)
Funder	Hoechst Marion Roussel (Shire Pharmaceuticals) (France)

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

Shire contact for trial - no PI identified
Hampshire International Business Park
Lime Tree Way
Basingstoke
RG24 8EP
United Kingdom

Study information

Primary study design	Interventional
Study design	Phase III, open-label extension study following the HMR4396B/3001 study
Secondary study design	Non randomised controlled trial
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
Phase	Phase III
Drug / device / biological / vaccine name(s)	HMR4396
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	16/09/2002

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	149
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

United Kingdom
England
United States of America

Study participating centre

Shire contact for trial - no PI identified

Basingstoke
RG24 8EP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan