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

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ClinicalTrials.gov Identifier: NCT02876419
Recruitment Status : Active, not recruiting
First Posted : August 23, 2016
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Hepatitis B, Chronic Hepatitis D, Chronic

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.

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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: A Long Term Follow-up Study of Patients From the REP 301 Protocol
Study Start Date : August 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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).


Biospecimen Retention:   Samples Without DNA
Frozen serum containing viral DNA / RNA


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients completing treatment exposure in the REP 301 protocol.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02876419


Locations
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Moldova, Republic of
Infectious Clinical Hospital (n.a. Toma Ciorba)
Chisinau, Moldova, Republic of, 2004
Sponsors and Collaborators
Replicor Inc.
Investigators
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Principal Investigator: Victor Pantea, MD Infectious Clinical Hospital (n.a. Toma Ciorba)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Replicor Inc.
ClinicalTrials.gov Identifier: NCT02876419     History of Changes
Other Study ID Numbers: REP 301-LTF
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Replicor Inc.:
nucleic acid polymer REP 2139 HBsAg hepatitis B hepatitis D

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis D
Hepatitis D, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic