Therapeutic Safety and Efficacy of REP 9AC (REP 2055) in HBV or HCV Infected Patients

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

The REP 101 protocol is the first-in-man proof of concept study designed to investigate the safety and antiviral activity of REP 2055 administration in human patients with chronic HBV or HCV infection.

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

Details

• Lead Sponsor: Replicor Inc.

Criteria

Inclusion Criteria (HBV):

• HBsAg+ for at least 6 months prior to initiation of treatment.

• HBeAg+

• HBV titer > 20000 copies/ml at start of treatment

• Treatment naïve

• HIV / hepatitis delta / HCV negative

• Compensated liver disease

• Ishak score ≤ 2

• Non cirrhotic

• No known active cytomegalovirus infection

• Willingness to utilize adequate contraception while being treated with REP 9AC (REP 2055) and for 6 months following the end of treatment

• Adequate venous access allowing weekly intravenous therapies and blood tests

Inclusion Criteria (HCV):

• HCV positive for at least 6 months prior to initiation of treatment

• Genotype 3

• HCV titer >3log IU/ml at start of treatment

• Treatment naïve

• HIV / hepatitis delta / HBV negative

• Compensated liver disease

• Chronic alanine aminotransferase or aspartate aminotransferase elevation for 6 months prior to treatment

• Ishak score ≤ 2 (patients should only have mild fibrosis)

• Non cirrhotic

• No known active cytomegalovirus infection

• Willingness to utilize adequate contraception while being treated with REP 9AC (REP 2055) and for 6 months following the end of treatment

• Adequate venous access allowing weekly intravenous therapies and blood tests

Exclusion Criteria (HBV + HCV):

• 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

• Anti-HIV 1: 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%

• Alfa 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

• Platelets 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 undergo a liver biopsy.

• Inability or unwillingness to provide weekly blood samples

• Poor venous access making weekly IV infusion too difficult