Step-down affordable treatment for chronic HEPatitis B infection in Africa

• Register: ISRCTN
• Last refreshed on: 24 May 2021
• Main ID: ISRCTN40785133
• Date of registration: 31/03/2014
• Prospective Registration: No
• Primary sponsor: Queen Mary University of London (UK)
• Public title: Step-down affordable treatment for chronic HEPatitis B infection in Africa
• Scientific title: Step-down affordable treatment for chronic hepatitis B infection in Africa: feasibility of treatment strategy
• Date of first enrolment: 06/01/2014
• Target sample size: 80
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN40785133
• Study type: Interventional
• Study design: Single group evaluation of feasibility of treatment strategy (Treatment)
• Phase: Not Applicable

Countries of recruitment

Zambia

Contacts

• Name: Graham Foster

Key inclusion & exclusion criteria

Inclusion criteria:
1. HBV viral load >105 copies/ml
2. Alanine aminotransferase (ALT) >1.3 times upper limit of normal (which sets the criterion at 45 i.u./l)
3. Evidence of inflammation on liver biopsy
4. May be either e antigen negative (n=40) or positive (n=40)

Exclusion criteria:
1. Histological or radiological evidence of cirrhosis
2. HIV infection
3. History of alcohol abuse or histological evidence of alcoholic liver disease
4. History of any long-term drug ingestion
5. Histological evidence of metabolic liver disease (haemochromatosis, Wilson?s disease, a1-antitrypsin deficiency) or autoimmune liver disease [antibodies to M2 antigen, Perinuclear antineutrophil cytoplasmic antibodies (p-ANCA), nuclear antigens, microsomes or smooth muscle]
6. Histological or radiological evidence of schistosomiasis
7. Histological evidence of hepatitis D virus (HDV) infection
8. Virological evidence of active hepatitis C virus (HCV) or hepatitis E virus (HEV) infection


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Hepatitis B infection
Infections and Infestations
Hepatitis B

Intervention(s)

Patients will be given Tenofovir 300mg daily (orally) for 52 weeks and then lamivudine 100mg (orally) daily for 26 weeks. Patients will be followed up for 6 months after starting lamivudine.

Primary Outcome(s)

Proportion of patients who successfully step down to lamivudine monotherapy with virological control of replication throughout

Secondary Outcome(s)

1. Proportion of patients who, even if there is virological rebound, achieve successful control on re-introduction of tenofovir
2. Accuracy of ALT monitoring in comparison with viral load monitoring
3. Accuracy of HBsAg quantification compared to viral load monitoring

The primary and secondary outcomes will be assessed by virological measurements in blood samples obtained every 3 months.

Secondary ID(s)

Step HEP

Source(s) of Monetary Support

Medical Research Council (MR/K007394/1)

Ethics review

Status:
Approval date:
Contact:

University of Zambia Biomedical Research Ethics Committee, 24/05/2013, ref: 005-02-13

Results

• Results available: Yes
• Date Completed: 01/09/2017