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Completed

NCT Number: NCT02876419

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

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.

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Key information

Conditions

Hepatitis B, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis D Hepatitis D, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Infectious Clinical Hospital (n.a. Toma Ciorba)

Chisinau, 2004, Moldova

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Long term safety (test abnormalities)

    Time frame: 3 years

    The proportion of patients with emergent lab test abnormalities.

  2. Long term safety (AEs)

    Time frame: 3 years

    Proportion of patients with adverse events.

  3. Long term safety (SAEs)

    Time frame: 3 years

    Proportion of patients with serious adverse events.

Secondary outcomes

  1. Long term efficacy (serum HBsAg)

    Time frame: 3 years

    Proportion of patients who maintain serum HBsAg < 1 IU/ml.

  2. Long term efficacy (serum anti-HBs)

    Time frame: 3 years

    Proportion of subjects who maintain anti-HBs titers above 10 mIU/ml.

  3. Long term efficacy (serum HBV DNA)

    Time frame: 3 years

    Proportion of patients who maintain serum HBV DNA < 10 IU / ml.

  4. Long term efficacy (serum HDV RNA)

    Time frame: 3 years

    Proportion of patients who maintain undetectable serum HDV RNA (target not detected).

Sponsors and collaborators

Lead sponsor

Replicor Inc.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 23, 2016
Registry last updated
Oct 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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