Primary biliary cirrhosis (PBC) Digestive System Fibrosis and cirrhosis of liver
Conditions
Interventions
This investigation is designed as a randomised, controlled, phase II pilot study of Combivir® in approximately 60 patients with PBC. It is expected that the majority of PBC patients will already be ta
Sponsors
Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be recruited from the Liver Out-Patients Department at the Queen Elizabeth Hospital: 1. Patients greater than 20 years old of either sex 2. Elevated alkaline phosphatase or alanine aminotransferase (ALT) within 3 months prior to the start of therapy 3. Positive serum anti-mitochondrial antibodies (AMA) (titre greater than 1:20) 4. Liver biopsy histology compatible with PBC
Exclusion criteria
Exclusion criteria: 1. Patients treated with immunosuppressive or anti-inflammatory agents 2. Advance liver disease: Child's class B or C 3. Patients with secondary hepatological diagnosis 4. Alcohol abuse (greater than 50 g of alcohol per day) 5. Other significant co-morbidity (e.g. cardiac or renal failure) 6. Pregnancy or breast feeding 7. Sexually active female of child bearing age not using effective contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed