Condition category
Infections and Infestations
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
16/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Truman Zimbwa

ORCID ID

Contact details

Department of Gastroenterology
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom
+44 (0)20 8510 5198
trmnzimbwa@aol.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0024131063

Study information

Scientific title

To investigate the role of folic acid in the management of ribavirin induced haemolytic anaemia in patients on combination treatment for chronic Hepatitis C virus infection

Acronym

Study hypothesis

The aim of this study is to assess if there are any beneficial effects of folic acid therapy in Ribavirin induced haemolytic anaemia.

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Infections and Infestations: Hepatitis C

Intervention

Randomised controlled trial
1. Folic Acid
2. Placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Folic acid

Primary outcome measures

Rate of haemoglobin drop and rise and number of patients who have to have Ribavirin dose reduced due to anaemia

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2003

Overall trial end date

30/08/2005

Reason abandoned

Participant recruitment issue

Eligibility

Participant inclusion criteria

60 patients with chronic hepatitis C virus infection on combination therapy (30 will get folic acid and 30 placebo)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/09/2003

Recruitment end date

30/08/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Gastroenterology
London
E9 6SR
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Homerton University Hospital NHS Trust (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

16/09/2016: The study was stopped 6 months after starting because of poor recruitment to study to be able to power it. 13/09/2016: No publications found in PubMed, verifying study status with principal investigator.