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 Available

Phase 1

• Conditions: Chronic hepatitis B virus infection

• Registration Number: EUCTR2005-005293-70-GB
• Lead Sponsor: Emergent Product Development UK Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-03-03
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 45

Inclusion Criteria

1. Able and willing to give written informed consent
2. Aged 18 years or older.
3. HBsAg positive for at least 6 months (with 2 separate positive test results at least 3 months apart).
4. a) 15 patients must be HBeAg positive with low ALT (=2 x ULN) and HBV DNA load =106 copies/mL (Group 1). b) 15 patients must be HBeAg positive, with high ALT (>2 x ULN and =5 x ULN) and HBV DNA load =106 copies/mL (Group 2). c) 15 patients must be HBeAg negative, with high ALT (>2 x ULN and =5 x ULN) and HBV DNA >105 copies/mL (Group 3).
5. Have a detailed medical history demonstrating stable ALT, PT and serum bilirubin with at least 2 readings in the previous 6 months and including a liver biopsy in the previous 24 months.
6. Available for the duration of the study and for unscheduled visits.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The following summarises the criteria that will exclude patients:Patients who have a history of anaphylaxis or hypersensitivity to the components of M04NM11, a known impairment of the immune system (HIV positive, immunosuppressant therapy or cytotoxic therapy). Patients with autoimmune diseases or hepatitis C or D. Patients with ALT >5.1x ULN, PT >1.25 x ULN or total bilirubin >1.5 x ULN. Patients who have evidence of hepatic decompensation. Patient who have had a liver biopsy with evidence of cirrhosis in the last 24 months. Patients who are involved in or have completed a clinical trial for hepatitis B within the previous 12 months, or for other conditions within the previous 3 months. Current or previous therapy with immunotherapies or anti-viral medications for hepatitis B in the last 12 months. Patients who have had a recent infection requiring antibiotics in the 7 days prior to dosing, or with hypersensitivity to ciprofloxacin, trimethoprim-sulfamethoxazole, or related antibiotics. Patients who have significantly abnormal laboratory findings, with the exception of LFTs as defined above, or have problems with addiction. Patients who work as food handlers, or health-care workers with direct contact with high-risk patients, or child-care workers with routine contact with children less than 2 years of age. Pregnant or breast feeding patients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified