ISRCTN96199656
Completed
未知
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 infection
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Chronic hepatitis B virus
- Sponsor
- Emergent Product Development UK Ltd (UK)
- Enrollment
- 45
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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A double blind, placebo controlled study to evaluate the safety and immunogenicity of escalating doses of 108 CFU, 109 CFU and 1010 CFU of M04NM11 in patients who have chronic Hepatitis B infection. - Not AvailableChronic hepatitis B virus infectionEUCTR2005-005293-70-GBEmergent Product Development UK Ltd45
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