A Korean Cohort Study of TDF Rescue Therapy for Difficult-to-treat CHB Patients: a Comparison Between TDF Monotherapy and TDF-based Combination Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1020 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-12

Study Completion Date

2017-08-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Antiviral resistance remains an important issue for long-term NA therapy. For lamivudine (LAM), the rtM204V/I and rtL180M mutations occur in more than 70% after 5 years of therapy. In Korea, primarily owing to limited subsidization policy in the health insurance system, many patients with LMV-resistance had been treated with either rescue ADV or ETV 1.0 mg monotherapy, ultimately leading to the higher prevalence of MDR strain. For those patients, rescue therapies of combining ADV with either ETV or LAM had been tried, but frequently with suboptimal responses. Rescue TDF monotherapy or TDF-based combination therapy are available in Korea for patients who had "difficult-to-treat" antiviral resistance owing to prior treatment failures. However, which is the better has not been evaluated yet. A long-term efficacy and safety of TDF-based rescue therapies in real practice for those patients should be necessary to revise the Korean guideline for the treatment of chronic hepatitis B in near future.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

TDF VS LAM + ADV in LAM + ADV Treated LAM-resistant CHB Patients With Undetectable Hepatitis B Virus DNA

NCT01732367

Chronic Hepatitis B

COMPLETED PHASE4

Tenofovir Combination or Mono-therapy for MDR CHB

NCT03597633

Chronic Hepatitis b With Multidrug Resistance

UNKNOWN

Switch From Adefovir to Tenofovir in Chronic Hepatitis B for Suboptimal Response to Adefovir-based Combination Therapy

NCT01595633

Chronic Hepatitis B

UNKNOWN PHASE4

Continuing Lamivudine Versus Switching to Entecavir in Patients Who Achieved Undetectable HBV DNA

NCT00625339

Hepatitis B, Chronic

COMPLETED PHASE4

Continuing Lamivudine vs Switching to Entecavir in Patients With Detectable HBV DNA

NCT00625560

Hepatitis B, Chronic

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

The Difficult-to-treat Chronic Hepatitis B

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TDF monotherapy

TDF monotherapy - treated by tenofovir alone

patients with CHB receiving rescue TDF (300mg once daily) monotherapy

No interventions assigned to this group

TDF-based combination therapy

TDF-based combination therapy - treated by tenofovir based combination therapy.

patients with CHB receiving rescue TDF-based combination therapy (TDF 300mg once daily with any other nucleoside analogue such as lamivudine 100mg, telbivudine 600mg, or entecavir 1.0 mg once daily).

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* more than 20 years old adults
* chronic hepatitis B
* the patients treated by tenofovir alone or tenofovir based combination therapy because of the previous treatment failure
* the patients who agree and singed on the consent form

Exclusion Criteria

* co-infected patients with HCV, HDV or HIV
* pregnancy or breast feeding woman or female patients who are planning to be pregnant
* past history with hepatocellular carcinoma
* combined with other liver disease including wilson, alcoholic, NASH, alpha-1 antitrypsin deficiency liver disease.
* patients with hypersensitivity for drugs
* patients who were enrolled in other clinical study within 60 days
* patients who were eligible for the clinical study according to the investor

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No