A Long Term Follow-up Study of Patients From the REP 301 Protocol

Study Overview
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Brief Summary
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The REP 301 treatment protocol involved the treatment of patients with chronic hepatitis B / hepatitis D co-infection with two agents: REP 2139-Ca and pegylated interferon (peg-IFN). In this protocol, similar reduction/clearance of serum HBsAg and improved response to immunotherapy were observed in addition to clearance of serum HDV RNA. The REP 301 protocol was designed to include a 24 week follow-up period after treatment, however given the strong antiviral response against HBV and HDV infection in these patients, it is now important to extend the follow-up period in these patients to monitor over a longer period after treatment the safety and efficacy combined REP 2139-Ca / peg-IFN treatment in patients in the REP 301 protocol.

Detailed Description
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The REP 301-LTF is a long-term follow-up, non-blinded study of patients from the REP 301 protocol. In this study, all eligible patients from the REP 301 protocol will have their followup evaluation extended for an additional 3 years, consisting of 6 visits scheduled every 6 months following the last follow-up visit scheduled in the REP 301 protocol. During each visit a physical examination and documentation of any symptoms, experiences will be conducted as well as blood tests for safety and virology as described below. This study will examine the long term safety effects in patients who have completed of treatment exposure in the REP 301 trial (REP 2139-Ca therapy for 30 weeks and PEG-IFN taken for 48 weeks with a 15 week overlap in combination) and the duration of suppression of serum HBV and HDV viremia observed in the REP 301 protocol. This requires that subjects have completed antiviral treatment in the REP 301 protocol and are not immediately transitioned to further antiviral treatment unless necessary. The total duration of this study for each subject is 3 years.

Official Title
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A Long Term Follow-up Study of Patients From the REP 301 Protocol

Conditions
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Hepatitis B, Chronic, Hepatitis D, Chronic

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Signed written informed consent. Exclusion Criteria: Any patients not enrolled in the REP 301 protocol or not successfully completing all treatment and follow-up visits in the REP 301 protocol 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 blood samples.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term safety (test abnormalities) | The proportion of patients with emergent lab test abnormalities. | 3 years | 
| Long term safety (AEs) | Proportion of patients with adverse events. | 3 years | 
| Long term safety (SAEs) | Proportion of patients with serious adverse events. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term efficacy (serum HBsAg) | Proportion of patients who maintain serum HBsAg < 1 IU/ml. | 3 years | 
| Long term efficacy (serum anti-HBs) | Proportion of subjects who maintain anti-HBs titers above 10 mIU/ml. | 3 years | 
| Long term efficacy (serum HBV DNA) | Proportion of patients who maintain serum HBV DNA < 10 IU / ml. | 3 years | 
| Long term efficacy (serum HDV RNA) | Proportion of patients who maintain undetectable serum HDV RNA (target not detected). | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nucleic acid polymer REP 2139 HBsAg hepatitis B hepatitis D