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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02233075
• Date of registration: 01/09/2014
• Prospective Registration: Yes
• Primary sponsor: Replicor Inc.
• Public title: REP 2139-Ca / Pegasys™ Combination Therapy in Hepatitis B / Hepatitis D Co-infection
• Scientific title: A Study of the Safety and Efficacy of Combination Treatment With REP 2139-Ca and Pegasys™ in Patients With Hepatitis B / Hepatitis D Co-infection
• Date of first enrolment: September 2014
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02233075
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Moldova, Republic of

Contacts

• Name: Victor Pantea, MD
• Affiliation: Infectious Diseases Department, State University of Medicine and Pharmacy

Key inclusion & exclusion 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



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

Health Condition(s) or Problem(s) studied

Chronic HBV Infection (HBeAg Negative)

Intervention(s)

Drug: REP 2139-Ca + Pegasys (TM)

Primary Outcome(s)

Number of patients experiencing a treatment-related adverse event. [Time Frame: Every week for 63 weeks.]

Secondary Outcome(s)

Number of patients with reduction of serum HBsAg. [Time Frame: Every two weeks for 63 weeks (treatment duration) + 24 weeks (follow-up)]

Number of patients with reduced serum HDV antigen / HDV RNA [Time Frame: Every two weeks for 63 weeks (treatment duration) + 24 weeks followup]

Number of patients with controlled HBV / HDV infection following treatment [Time Frame: 24 weeks follow up (after completion of 63 weeks of treatment)]

Secondary ID(s)

REP 301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors