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
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

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

Study information

Study designPhase III, open-label extension study following the HMR4396B/3001 study
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesAdvanced 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) studiedAnaemia
InterventionThe 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 typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)HMR4396
Primary outcome measureThe 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 measuresThe 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 date03/08/2000
Completion date16/09/2002

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants149 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 criteria1. Completion of the HMR4396B/3001 study
2. Informed consent was obtained from all subjects before enrolment into the study
Key exclusion criteriaSubjects 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 enrolment03/08/2000
Date of final enrolment16/09/2002

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

Sponsor information

Hoechst Marion Roussel (Shire Pharmaceuticals) (France)
Industry

102 Route de Noisy
Romainville, Cedex
93235
France

Website http://www.shire.com/shire/
ROR logo "ROR" https://ror.org/02n6c9837

Funders

Funder type

Industry

Hoechst Marion Roussel (Shire Pharmaceuticals) (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan