Condition category
Haematological Disorders
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
19/02/2014
Prospective/Retrospective
Prospectively 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 - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GN308

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Anaemia

Intervention

Patients are randomised to one of two treatment arms:
1. Arm A: Patients receive 150 IU/Kg of Epoetin alpha
2. Arm B: Patients receive matching placebo

Epoetin alpha or placebo is given subcutaneously three times per week for the first four weeks (or the first on-study chemotherapy cycle, respectively). Haemaglobin level and/or reticulocyte count will then be used to determine whether the same dose (volume) or a doubled dose (volume) will be used for the remainder of the treatment.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2003

Overall trial end date

01/01/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of non-myeloid malignancy, which requires non-platinum containing chemotherapy
2. Predicted chemotherapy of 12 to 24 weeks (three to six cycles) duration
3. Performance score zero to three
4. Life expectancy of more than six months
5. Aged over 18 years
6. Patients with acute leukaemia are excluded
7. No myeloablative chemotherapy
8. No uncontrolled hypertension
9. No evidence of untreated iron, folate or vitamin B12 deficiency

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not comply with the above inclusion criteria

Recruitment start date

01/01/2003

Recruitment end date

01/01/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Janssen-Cilag Ltd (UK)

Sponsor details

Saunderton
High Wycombe
HP14 4HJ
United Kingdom
+44 (0)1494 567567

Sponsor type

Industry

Website

http://www.janssen-cilag.co.uk

Funders

Funder type

Industry

Funder name

Janssen-Cilag Ltd (UK)

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