A double blind, placebo controlled study to evaluate the safety and immunogenicity of escalating doses of 10^8 colony forming units (CFU), 10^9 CFU and 10^10 CFU of M04NM11 in patients who have chronic hepatitis B infectio

Not Applicable

Completed

• Conditions: Chronic hepatitis B virus; Infections and Infestations; Chronic viral hepatitis

• Registration Number: ISRCTN96199656
• Lead Sponsor: Emergent Product Development UK Ltd (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-26
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Participating patients must be over 18 years of age, either sex
2. Have been hepatitis B surface antigen (HBsAg) positive for at least six months
3. A detailed medical history demonstrating stable alanine aminotransferase (ALT), prothrombin time (PT) and serum bilirubin and a liver biopsy in the previous 24 months
4. Patients will be stratified and recruited according to hepatitis B 'e' antigen (HBeAg) status and viral deoxyribonucleic acid (DNA) load

Exclusion Criteria

1. Have any hypersensitivity to the investigational medicinal product (IMP)
2. Are hepatitis C virus (HCV) or hepatitis D virus (HDV) positive
3. Are receiving or have received medication for their hepatitis B in the previous 12 months
4. Have evidence of hepatic decompensation, cirrhosis or ALT greater than 5.1 x upper limit of normal (ULN), PT greater than 1.25 x ULN or total bilirubin greater than 1.5 x ULN
5. Immuno-suppression or close contact with immuno-suppressed people

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. The incidence of clinically significant changes in serum biochemistry and haematology tests, particularly elevations of ALT or bilirubin, or prolongation of PT<br>2. The incidence of adverse events, including flu-like symptoms, attributable to the investigational product<br>3. The incidence of serious adverse events attributable to the investigational product<br><br>The primary outcome measures will be at screening; on days 3, 7, 14 and 28 after the first dose; days 7, 14 and 28 after the second dose and days 14 and 28 after subsequent doses. Following receipt of the final dose, patients will be followed up for a further 20 weeks up to day 308.