Condition category
Haematological Disorders
Date applied
20/06/2007
Date assigned
06/08/2007
Last edited
02/09/2008
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 Francis Ssali

ORCID ID

Contact details

Plot 893 Ring Road
Butikiro House - Mengo
Kampala
P.O. Box 10005
Uganda
+256 41 270283/270622
ssalifran@yahoo.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HS 103

Study information

Scientific title

Acronym

The Wepox study

Study hypothesis

Erythropoietin is efficacious in improving the haemoglobin among anaemic HIV+ individuals at a lower than the currently recommended dose of 40,000 IU per week or 100 - 300 IU/Kg three times per week.

Ethics approval

Ethics approval received from:
1. Ethics committee of the Faculty of Medicine, Makerere University on 29th December 2005. Renewed on the 23rd April 2007 and will expire on 23rd October 2007.
2. Uganda National Council for Science and Technology (UNCST) on 18th January 2006. Renewed on the 10th May 2007 and will expire on the 13th April 2008 (ref: HS103).

Study design

Open label randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

HIV associated anaemia

Intervention

Each participant will be randomised to one of the following four groups:
1. Intervention group 1: Haematinics (one capsule orally once daily) and erythropoietin (Wepox) 2000 IU three times per week subcutaneously for 4 weeks
2. Intervention group 2: Haematinics (one capsule orally once daily) and erythropoietin (Wepox) 4000 IU once a week subcutaneously for 4 weeks
3. Intervention group 3: Haematinics (one capsule orally once daily) and erythropoietin (Wepox) 2000 IU once a week subcutaneously for 4 weeks
4. Control group: Haematinics (one capsule orally once daily) for 4 weeks

The haematinic capsule contains 305 mg ferrous fumarate equivalent to 100 mg elemental iron, 0.75 mg folic acid, 5 micrograms cyanocobalamin, 75 mg ascorbic acid and 5.0 mg zinc sulphate.

Interim analysis of this study will be carried out in July 2007. Final evaluation of the study will be carried out on completion of the study enrolment and follow-up, but the latter may be influenced by the results of the interim analysis.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Change in haemoglobin, measured at week 0 and end of week 4.

Secondary outcome measures

1. Quality of life improvement, measured at week 0 and end of week 4 using a visual analogue scale (LASA) and the Medical Outcomes Study HIV Health Survey (MOSHIV) instrument
2. Adverse events

Overall trial start date

01/03/2006

Overall trial end date

01/04/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Documented HIV positive
2. Grade 1 and 2 anaemia
3. Informed consent
4. Age 18 to 65 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Recent blood loss
2. Active opportunistic infection
3. Presence of fever at the time of enrolment
4. Pregnancy
5. Cancer chemotherapy
6. Severe microcytosis
7. Systemic hypertension
8. Known allergy to erythropoietin

Recruitment start date

01/03/2006

Recruitment end date

01/04/2008

Locations

Countries of recruitment

Uganda

Trial participating centre

Plot 893 Ring Road
Kampala
P.O. Box 10005
Uganda

Sponsor information

Organisation

Star Pharmaceuticals Ltd (Uganda)

Sponsor details

Plot 20/3
Jinja Road
Opposite Spear House
Kampala
PO Box 4391
Uganda
+256 41 232863
starpharm@infocom.co.ug

Sponsor type

Industry

Website

http://www.staruganda.com

Funders

Funder type

Industry

Funder name

Star Pharmaceuticals Uganda Ltd (Uganda) - local representative for Wockhardt

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