Condition category
Haematological Disorders
Date applied
12/06/2007
Date assigned
19/07/2007
Last edited
15/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Chris Freitag

ORCID ID

Contact details

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

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

http://www.shire.com/shire/

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

Publication citations

Additional files

Editorial Notes