Chronic hepatitis B virus infection
Conditions
Interventions
Product Name: M04NM11 Hepatitis B Immunotherapy
Product Code: Not Applicable
Pharmaceutical Form: Oral solution
INN or Proposed INN: N/A
Sponsors
Emergent Product Development UK Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety of M04NM11 compared to placebo, when administered orally in escalating doses, of 108 CFU, 109 CFU and 1010 CFU, up to a maximum total of 6 doses, 28 days apart, over a 6 month period, to patients that are chronic carriers of the hepatitis B virus (HBV).; Secondary Objective: To assess the proportion of patients who are chronic carriers of HBV who experience a reduction in HBV DNA load during treatment with up to 6 doses of M04NM11. A decrease of = 2 log10 or a reduction to < 104 copies/mL will be considered clinically significant. To explore whether any patients who are HBeAg positive become HBeAg negative over the course of the study. To explore whether any patients become anti-HBe positive during the study. To explore whether any patients experience a reduction in ALT levels to within the normal range. To explore whether any patients mount an immune response of a Th1 type by quantitation of antigen specific T cells that produce IFN-g to HBcAg as assessed by ELISPOT and intracellular cytokine staining. To evaluate the post treatment effects of M04NM11 in the 6-month period following completion of dosing. ; Primary end point(s): The incidence of clinically significant changes in serum biochemistry and haematology tests, particularly elevations of ALT or bilirubin, or prolongation of PT. The incidence of adverse events, including flu-like symptoms, attributable to the investigational product. The incidence of serious adverse events attributable to the investigational product | — |
Countries
United Kingdom
Outcome results
None listed