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

October 5, 2020 updated by: Replicor Inc.
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Moldova, Republic of
      • Chisinau, Moldova, Republic of, 2004
        • Infectious Clinical Hospital (n.a. Toma Ciorba)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients completing treatment exposure in the REP 301 protocol.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Replicor Inc.

Investigators

  • Principal Investigator: Victor Pantea, MD, Infectious Clinical Hospital (n.a. Toma Ciorba)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

November 13, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimate)

August 23, 2016

Study Record Updates

Last Update Posted (Actual)

October 6, 2020

Last Update Submitted That Met QC Criteria

October 5, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REP 301-LTF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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