A pilot study of thalidomide therapy for alcoholic hepatitis
| ISRCTN | ISRCTN40686096 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40686096 |
| Protocol serial number | N0265006466 |
| Sponsor | Department of Health |
| Funder | University Hospital Birmingham NHS Trust (UK) - Internal funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 24/11/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Digestive System
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
Prof DH Adams
Scientific
Scientific
Liver Medicine
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Will suppression of tumour necrotising factor alpha (TNF-a) production by the use of thalidomide lead to a reduction in morbidity and/or mortality in alcoholic hepatitis? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Alcoholic hepatitis |
| Intervention | Patients referred to the Liver Unit for management of acute alcoholic hepatitis will be invited to participate in the trial provided that they fulfill inclusion criteria according to our proposed protocol. They will be given the study medications or placebo for a total of four weeks and will be monitored during and following this period of trial therapy. Please note, this trial never started due to logistic problems. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Thalidomide |
| Primary outcome measure(s) |
Survival or death, since severe AH carries a mortality of 50% within two months. |
| Key secondary outcome measure(s) |
1. Onset of complications such as bacterial or fungal sepsis |
| Completion date | 01/01/2007 |
| Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Liver Medicine
Birmingham
B15 2TH
United Kingdom
B15 2TH
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 |
