Combination Treatment With REP 2139-Ca and Pegasys in Patients With Chronic Hepatitis B
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: REP 2139-Ca; pegylated interferon; entecavir
Intervention description: the nucleic acid polymer REP 2139 formulated as a calcium chelate complex; immunotherapy; local generic entecavir
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a; Entecavir; REP 2139
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: nucleic acid polymer REP 2139 HBsAg hepatitis B

Summary:

      The REP 201 protocol is a small exploratory study assessing the antiviral effects and
      tolerability of REP 2139-Ca when used with a full course of pegylated interferon (48 weeks)
      in treatment naive patients or in patients already receiving entecavir and continuing
      entecavir with treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age between 18 and 55

          -  HBsAg+

          -  Anti-HBs negative

          -  Patients currently receiving nucleoside based HBV polymerase inhibitors may be
             included in the study at the discretion of the Principle Investigator.

          -  HIV / hepatitis C / hepatitis delta virus negative

          -  Fibrosis with compensation (as determined by Fibroscan and liver enzymes)

          -  Non cirrhotic

          -  No known active cytomegalovirus infection

          -  Willingness to utilize adequate contraception while being treated with REP 9AC' and
             for 6 months following the end of treatment

          -  Adequate venous access allowing weekly intravenous therapies and blood tests

        Exclusion Criteria:

          -  Evidence of cardiovascular disease

          -  Autoimmune hepatitis

          -  Presence of Wilson's disease

          -  Presence of severe NAFLD

          -  Evidence of any other co-existent liver disease

          -  Anti-nuclear antibody positive

          -  Ultrasonograph of hepato-biliary system: positive for cirrhosis of liver

          -  A history of ascites, hepatic encephalopathy or variceal hemorrhage

          -  Body weight > 100 kg

          -  Platelet count < 75,000, polymorphonuclear cell count < 1,500 or hematocrit < 33%

          -  alpha feto protein > 100 ng/ml or the presence of a hepatic mass suggestive of
             hepatocellular carcinoma .

          -  Bilirubin > 2.5 mg/dl

          -  Creatinine > 1.5 mg/dl

          -  Platelet count < 75,000 / cmm

          -  Serum albumin < 35 mg/ml

          -  Poorly controlled diabetes mellitus

          -  Another serious medical disorder

          -  A serious psychiatric disorder

          -  Uncontrolled hypertension

          -  A history of alcohol abuse within the last year

          -  The use of illicit drugs within the past two years

          -  Inability to provide informed consent

          -  Positive pregnancy test

          -  Breastfeeding

          -  Inability or unwillingness to provide weekly blood samples

          -  Poor venous access making IV infusion too difficult