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

• Register: ClinicalTrials.gov
• Last refreshed on: 18 January 2016
• Main ID: NCT02646189
• Date of registration: 03/01/2016
• Prospective Registration: No
• Primary sponsor: Replicor Inc.
• Public title: Therapeutic Safety and Efficacy of REP 2139 (REP 9AC') in HBV Infected Patients
• Scientific title: Therapeutic Safety and Efficacy of REP 2139 (REP 9AC') in HBV Infected Patients
• Date of first enrolment: August 2011
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02646189
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

Bangladesh

Contacts

• Name: Mamun Al-Mahtab, MD
• Affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hepatitis B, Chronic

Intervention(s)

Drug: Pegasys

Drug: REP 2139-Ca

Drug: Zadaxin

Primary Outcome(s)

Safety and tolerability of REP 2139-Ca + immunotherapy [Time Frame: 40 weeks (treatment)]

Secondary Outcome(s)

Efficacy of REP 2139-Ca + immunotherapy [Time Frame: 40 weeks (treatment) + 52 weeks (follow up)]

Secondary ID(s)

REP 102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors