Combination Treatment With REP 2139-Ca and Pegasys in Patients With Chronic Hepatitis B

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Replicor Inc.
• Treatments: Entecavir; Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; REP 2139

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