NCT02876419

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 23, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2019

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

3.3 years

First QC Date

August 16, 2016

Last Update Submit

October 5, 2020

Conditions

Hepatitis B, ChronicHepatitis D, Chronic

Keywords

nucleic acid polymer REP 2139 HBsAg hepatitis B hepatitis D

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Long term efficacy (serum HBsAg)

    3 years

  • Long term efficacy (serum anti-HBs)

    3 years

  • Long term efficacy (serum HBV DNA)

    3 years

  • Long term efficacy (serum HDV RNA)

    3 years

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients completing treatment exposure in the REP 301 protocol.

You may qualify if:

  • \. Signed written informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Infectious Clinical Hospital (n.a. Toma Ciorba)

Chisinau, 2004, Moldova

Location

Related Publications (2)

  • Bazinet M, Pantea V, Cebotarescu V, Cojuhari L, Jimbei P, Anderson M, Gersch J, Holzmayer V, Elsner C, Krawczyk A, Kuhns MC, Cloherty G, Dittmer U, Vaillant A. Persistent Control of Hepatitis B Virus and Hepatitis Delta Virus Infection Following REP 2139-Ca and Pegylated Interferon Therapy in Chronic Hepatitis B Virus/Hepatitis Delta Virus Coinfection. Hepatol Commun. 2020 Nov 13;5(2):189-202. doi: 10.1002/hep4.1633. eCollection 2021 Feb.

    PMID: 33553968DERIVED

  • Bazinet M, Pantea V, Cebotarescu V, Cojuhari L, Jimbei P, Albrecht J, Schmid P, Le Gal F, Gordien E, Krawczyk A, Mijocevic H, Karimzadeh H, Roggendorf M, Vaillant A. Safety and efficacy of REP 2139 and pegylated interferon alfa-2a for treatment-naive patients with chronic hepatitis B virus and hepatitis D virus co-infection (REP 301 and REP 301-LTF): a non-randomised, open-label, phase 2 trial. Lancet Gastroenterol Hepatol. 2017 Dec;2(12):877-889. doi: 10.1016/S2468-1253(17)30288-1. Epub 2017 Sep 28.

    PMID: 28964701DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Frozen serum containing viral DNA / RNA

MeSH Terms

Conditions

Hepatitis B, ChronicHepatitis D, Chronic

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHepatitis DRNA Virus Infections

Study Officials

  • Victor Pantea, MD

    Infectious Clinical Hospital (n.a. Toma Ciorba)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2016

First Posted

August 23, 2016

Study Start

August 1, 2016

Primary Completion

November 13, 2019

Study Completion

December 1, 2019

Last Updated

October 6, 2020

Record last verified: 2020-10

Locations

MO(1)