Therapeutic Safety and Efficacy of REP 2139 (REP 9AC') in HBV Infected Patients

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

REP 9AC (REP 2055) is a nucleic acid polymer (NAP) with entry and post-entry antiviral activity against duck hepatitis B virus (DHBV) infection. REP 2055 has been shown to have potent therapeutic effect against established DHBV infection in vivo

REP 2055 was additionally shown to have significant antiviral effects in patients with chronic HBV infection in the previous REP 101 study. REP 2139 is a version of REP 2055 designed for improved administration tolerability and stability.

The safety and antiviral activity REP 2139, first in monotherapy and then in combination with immunotherapy in patients with chronic HBV infection will be assessed in the REP 102 protocol.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• HBsAg+

• Anti-HBs negative

• HBV titer > 1x10^7 copies / ml

• Treatment naïve

• HIV / HCV / 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

• Evidence of liver cirrhosis

• 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