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
| ISRCTN | ISRCTN07377784 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07377784 |
| Protocol serial number | N0024131063 |
| Sponsor | Department of Health |
| Funder | Homerton University Hospital NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 16/09/2016
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Infections and Infestations
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 Truman Zimbwa
Scientific
Scientific
Department of Gastroenterology
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom
| Phone | +44 (0)20 8510 5198 |
|---|---|
| trmnzimbwa@aol.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Infections and Infestations: Hepatitis C |
| Intervention | Randomised controlled trial 1. Folic Acid 2. Placebo |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Folic acid |
| Primary outcome measure(s) |
Rate of haemoglobin drop and rise and number of patients who have to have Ribavirin dose reduced due to anaemia |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/08/2005 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 60 |
| Key inclusion criteria | 60 patients with chronic hepatitis C virus infection on combination therapy (30 will get folic acid and 30 placebo) |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/09/2003 |
| Date of final enrolment | 30/08/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Gastroenterology
London
E9 6SR
United Kingdom
E9 6SR
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
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.
