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Status:

ACTIVE_NOT_RECRUITING

Effectiveness of TAF in Reducing Clinical Events in CHB Patients Beyond Treatment Indications by Current Guidelines

Lead Sponsor:

Young-Suk Lim

Collaborating Sponsors:

Samsung Medical Center

Kyunghee University Medical Center

Conditions:

Chronic Hepatitis b

Eligibility:

All Genders

40-80 years

Phase:

PHASE4

Brief Summary

Treatment with Tenofovir Alafenamide(TAF) in Chronic Hepatitis B (CHB) patients classified as beyond treatment indication of current international guidelines (e.g. aged more than 40 years old and 4 ≤ ...

Detailed Description

Study objectives: To investigate whether TAF treatment reduce clinical events (HCC, death, liver decompensation, portal hypertensive complications, and liver transplantation) in CHB patients beyond tr...

Eligibility Criteria

Inclusion

  • Patients must meet all of the following criteria to be eligible to participate in the study
  • Patient must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures
  • Male or female, 40 to 80 years of age
  • Positive for HBsAg or HBV DNA for at least 6 months or more
  • HBeAg positive or negative
  • No evidence of liver cirrhosis (platelet count ≥100,000/mm3)
  • serum HBV DNA ≥ 4 log10 IU/mL and ≤ 8 log10 IU/mL
  • Serum ALT level \<70 if male, \<50 if female
  • Estimated creatinine clearance ≥ 30 ml/min based on serum creatinine as measured at the screening evaluation
  • Patient is willing and able to comply with all study requirements

Exclusion

  • Patients who meet any of the following exclusion criteria are not to be enrolled in this study
  • Co-infection with HCV, HDV, HIV (Confirmed by nucleic acid tests)
  • Abusing alcohol (more than 60 g/day) or illicit drugs
  • Patients with history of hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage)
  • 4-1) Evidence of cirrhosis, including any of follows:
  • Platelet count \<100,000/mm3
  • Esophagogastric varices on endoscopy
  • Evidence of clinically significant portal hypertension
  • Fibroscan ≥ 12.0 kPa (If the test was done in 3 months before the time of screening.) and confirmed to have liver cirrhosis by an investigator
  • 4-2) 40≤ALT levels\<70 IU/L (males) or 40≤ ALT levels\<50 IU/L (females) with evidence of significant fibrosis(F2; ≥7.2 kPa) as measured by either liver biopsy, Fibroscan or MR elastograpy performed within 3 months.
  • 5\. Received interferon or other immunomodulatory treatment for HBV infection in the 12 months before screening for this study
  • 6\. Medical condition that requires concurrent use of systemic corticosteroid or other immunosuppressive agents
  • 7\. Received solid organ or bone marrow transplant
  • 8\. Known hypersensitivity to study drugs, metabolites, or formulation excipients
  • 9\. Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the patient unsuitable for the study or unable to comply with dosing requirements
  • 10\. Use of investigational agents within 6 months of screening, unless allowed by the Sponsor or Investigator
  • 11\. Significant renal, cardiovascular, pulmonary, or neurological disease in the opinion of the Investigator
  • 12\. Any malignant tumor in the preceding five years. However, a history of treated malignancy (other than HCC) is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding three years
  • 13\. Pregnant or breastfeeding or willing to be pregnant
  • 14\. Participating in other clinical trials to administer medication. However, it is possible to participate if it is not an antiviral agent or immunosuppressant related clinical trial.

Key Trial Info

Start Date :

February 18 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2031

Estimated Enrollment :

780 Patients enrolled

Trial Details

Trial ID

NCT03753074

Start Date

February 18 2019

End Date

December 31 2031

Last Update

December 17 2024

Active Locations (10)

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Page 1 of 3 (10 locations)

1

Kyungpook National University Hospital

Daegu, South Korea

2

Seoul National University Bundang Hospital

Seongnam, South Korea

3

Asan Medical Center

Seoul, South Korea, 05505

4

Chung-Ang University Hospital

Seoul, South Korea