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

Not Applicable

Completed

• Conditions: Hepatitis B infection; Infections and Infestations; Hepatitis B

• Registration Number: ISRCTN40785133
• Lead Sponsor: Queen Mary University of London (UK)

Brief Summary

2017 baseline liver pathology in https://pubmed.ncbi.nlm.nih.gov/29378031/ (added 10/05/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-31
• Study Completion: 2017-09-01
• Last Update Posted: 24 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified