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

Completed

• Conditions: Hepatitis D, Chronic; Hepatitis B, Chronic

• Registration Number: NCT02876419
• Lead Sponsor: Replicor Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-18
• Study First Posted: 2016-08-23
• Primary Completion: 2019-11-13
• Study Completion: 2019-12
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

1. Signed written informed consent.

Exclusion Criteria

1. Any patients not enrolled in the REP 301 protocol or not successfully completing all treatment and follow-up visits in the REP 301 protocol
2. A history of alcohol abuse within the last year
3. The use of illicit drugs within the past two years.
4. Inability to provide informed consent.
5. Inability or unwillingness to provide blood samples.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Long term safety (SAEs)	3 years	Proportion of patients with serious adverse events.
Long term safety (test abnormalities)	3 years	The proportion of patients with emergent lab test abnormalities.
Long term safety (AEs)	3 years	Proportion of patients with adverse events.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Infectious Clinical Hospital (n.a. Toma Ciorba); 🇲🇩 Chisinau, Moldova, Republic of