NCT02482272

Brief Summary

The purpose of this study is to compare efficacy and safety of continuing Lamivudine plus Adefovir or Adefovir versus switching to Entecavir plus Adefovir in patients with LAM-resistant chronic hepatitis B who have suboptimal response to Lamivudine plus Adefovir or Adefovir

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 1, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 26, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

1.7 years

First QC Date

June 1, 2015

Last Update Submit

December 29, 2015

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with HBV DNA<15IU/mL

    week 48

Secondary Outcomes (8)

  • Proportion of patients with HBV DNA<15IU/mL

    Day1, week12, week 24, week 36, week 48

  • The change of HBV DNA from the baseline

    week 48

  • Proportion of patients with ALT normalization

    Day1, week12, week 24, week 36, week 48

  • Proportion of patients with HBeAg loss and/or seroconversion

    Day1, week12, week 24, week 36, week 48

  • The change of HBsAg from the baseline

    week 48

  • +3 more secondary outcomes

Study Arms (2)

Lamivudine plus Adefovir or Adefovir

ACTIVE COMPARATOR

Lamivudine+Adefovir or Adefovir for 48 weeks

Drug: LamivudineDrug: Adefovir

Entecavir plus Adefovir

EXPERIMENTAL

Entecavir+Adefovir for 48 weeks

Drug: AdefovirDrug: Entecavir

Interventions

LamivudineDRUG

Lamivudine 100mg/day orally

Lamivudine plus Adefovir or Adefovir
AdefovirDRUG

Adefovir 10mg/day orally

Entecavir plus AdefovirLamivudine plus Adefovir or Adefovir
EntecavirDRUG

Entecavir 1mg/day orally

Entecavir plus Adefovir

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic hepatitis B
  • Age ≥ 20 year old
  • Currently taking Lamivudine and Adefovir combination therapy or Adefovir monotherapy for chronic HBV infection for 24 weeks
  • Proven Lamivudine resistant mutation
  • HBV DNA levels at screening ≥ 15 IU/mL
  • Females must be post-menopausal, unable to conceive, or test negative for pregnancy via urine test
  • Patient is able to give written informed consent prior to study start and to comply with the study requirements

You may not qualify if:

  • A history or current of decompensated cirrhosis or hepatocellular carcinoma
  • Currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy
  • Co-infected with HCV or HIV
  • A history of organ transplantation
  • Pregnant or breast-feeding
  • Current clinically relevant of abuse of alcohol or drugs.
  • Significant immunocompromised, gastrointestinal, renal(serum creatinine ≥ 1.5 mg/dL), hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic, allergic disease or medical illness that in the investigator's opinion might interfere with therapy
  • malignancy in previous 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Lamivudineadefovirentecavir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosides

Central Study Contacts

Danbi Lee

CONTACT

82)2-3010-3907leighdb@hanmail.net

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 1, 2015

First Posted

June 26, 2015

Study Start

May 1, 2015

Primary Completion

January 1, 2017

Study Completion

May 1, 2017

Last Updated

December 30, 2015

Record last verified: 2015-12

Locations

KR(1)