REP 2139-Ca / Pegasys™ Combination Therapy in Hepatitis B / Hepatitis D Co-infection

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

Summary

REP 2139-Ca is nucleic acid polymer. Nucleic acid polymers have been previously shown to clear serum hepatitis B virus surface antigen (HBsAg) both preclinically (in duck HBV infected ducks) and in human patients and to act synergistically with immunotherapeutic agents such as pegylated interferon-alpha 2a or thymosin alpha-1 to restore host immunological control of HBV infection.

HBsAg is an essential component of the hepatitis D virus (HDV), therefore the direct action of REP 2139-Ca in removing serum HBsAg and its synergistic effect with pegylated interferon-alpha 2a is expected to have a significant antiviral effect against HDV infection.

This study will examine the safety and efficacy of REP 2139-Ca therapy when used in combination with pegylated interferon alpha-2a in patients with HBV / HDV co-infection.

The primary hypothesis to be tested is that this combined dosing regimen is safe and well tolerated in patients with HBV / HDV co-infection which will be assessed by examining the number of patients with adverse events (including reported symptoms and laboratory abnormalities).

The secondary hypothesis to be tested is that this combined dosing regimen will have an antiviral effect against HBV / HDV co-infection in these patients which will be assessed by examining the following outcomes:

1. The number of patients with reductions in serum HBsAg.

2. The number of patients with reductions in serum HDAg and HDV RNA

3. The number of patients that experience a sustained antiviral response after treatment is stopped (reductions in serum HBV DNA and HDV RNA).

The secondary hypothesis to be tested is that this combination approach can have an effective

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

Details

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

Criteria

Inclusion Criteria:

• Age between 18 and 55 years

• HBsAg > 1000 IU / ml

• HDAg+

• HDV RNA +

• No detectable antibodies to HIV, HCV or CMV.

• Non cirrhotic

• Willingness to utilize adequate contraception while being treated with REP 213-Ca and for 6 months following the end of treatment

• Adequate venous access allowing weekly intravenous therapies and blood tests

• Body Mass Index (BMI) ≥ 18 kg/m2 and ≤ 25 kg/m2

Exclusion Criteria:

• Evidence of cardiovascular disease

• Evidence of autoimmune hepatitis

• Presence of Wilson's disease

• Presence of severe NAFLD

• Evidence of any other co-existent liver disease

• ANA (anti-nuclear antibody) positive

• Fibroscan and Fibromax showing evidence of advanced cirrhosis.

• Any history of ascites, hepatic encephalopathy or variceal hemorrhage

• Body weight > 100 kg

• Platelet count < 90,000, PMN count < 1,500 or HCT < 33%

• Evidence of significant heavy metal load in whole blood.

• AFP > 100 ng/ml or the presence of a hepatic mass suggestive of HCC

• Bilirubin above the normal range

• ALT > 5x ULN

• Creatinine > 1.5 mg/dl

• Serum albumin < 35 mg/ml

• The presence of diabetes (whether controlled or uncontrolled)

• Another serious medical disorder

• A serious psychiatric disorder

• Evidence of 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

• Inability or unwillingness to provide weekly blood samples

• Poor venous access making IV infusion too difficult

• Patient not willing to come every week to receive therapy