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Trial record 159 of 349 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT02019966
First received: December 18, 2013
Last updated: August 18, 2016
Last verified: August 2016
  Purpose
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.

Condition
The Difficult-to-treat Chronic Hepatitis B

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • The proportion of subjects who achieve a sustained HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) at each year during the on treatment follow-up period. [ Time Frame: 1, 2, and 3 years after the treatment initiation. ]
    The viral response which is defined as serum HBV DNA < 60 IU/mL


Estimated Enrollment: 1000
Study Start Date: August 2014
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
TDF monotherapy

TDF monotherapy - treated by tenofovir alone

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

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).


  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chronic hepatitis B patients who had "difficult-to-treat" antiviral resistance owing to prior treatment failures
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02019966

Contacts
Contact: Sang Hoon Ahn, MD +82-2-2228-1936 ahnsh@yuhs.ac

Locations
Korea, Republic of
Department of Internal Medicine, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Sang Hoon Ahn, MD    +82-2-2228-1936    ahnsh@yuhs.ac   
Sponsors and Collaborators
Yonsei University
  More Information

Publications:
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02019966     History of Changes
Other Study ID Numbers: 4-2013-0704 
Study First Received: December 18, 2013
Last Updated: August 18, 2016

Additional relevant MeSH terms:
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human

ClinicalTrials.gov processed this record on February 24, 2017