Status:
COMPLETED
REP 2139-Ca / Pegasys™ Combination Therapy in Hepatitis B / Hepatitis D Co-infection
Lead Sponsor:
Replicor Inc.
Conditions:
Chronic HBV Infection (HBeAg Negative)
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief 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 hu...
Detailed Description
Nucleic acid polymers (NAPs) utilize the sequence independent properties of phosphorothioated oligonucleotides to target apolipoprotein interactions involved in the formation of HBV subviral particles...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02233075
Start Date
September 1 2014
End Date
May 1 2017
Last Update
September 28 2017
Active Locations (1)
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1
Infectious Clinical Hospital ( n.a. Toma Ciorba)
Chisinau, Moldova, 2004