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

Primary Purpose

Chronic Hepatitis b

Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tenofovir Alafenamide
Sponsored by
Young-Suk Lim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis b

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must meet all of the following criteria to be eligible to participate in the study

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

Exclusion Criteria: Patients who meet any of the following exclusion criteria are not to be enrolled in this study

  1. Co-infection with HCV, HDV, HIV (Confirmed by nucleic acid tests)
  2. Abusing alcohol (more than 60 g/day) or illicit drugs
  3. Patients with history of hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage)
  4. Evidence of cirrhosis, including any of follows:

1) Platelet count <100,000/mm3 2) Esophagogastric varices on endoscopy 3) Evidence of clinically significant portal hypertension

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.

Sites / Locations

  • Kyungpook National University HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Chung-Ang University HospitalRecruiting
  • Konkuk University HospitalRecruiting
  • Korea University Guro HospitalRecruiting
  • Kyung-Hee University HospitalRecruiting
  • Samsung Medical centerRecruiting
  • Seoul National University HospitalRecruiting
  • The Catholic University of Korea, Seoul ST. Mary's Hospital
  • Ulsan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Arm A (TAF)

Treatment Arm B (Best supportive care)

Arm Description

390 subjects administered Tenofovir Alafenamide 25 mg once daily

390 subjects received best supportive care During treatment period, among treatment arm B, subjects who are indicated for antiviral treatment will be treated with TAF as follows: Based on the AASLD 2018 Guidelines of CHB (ALT 70≥ for male, 50≥ for female) 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. If they were clinically judged to have cirrhosis by investigators and confirmed with Fibroscan (≥ 12.0 kPa).

Outcomes

Primary Outcome Measures

Cumulative rate of patients with clinical events
Cumulative rate of patients with clinical events (death, liver transplantation, liver decompensation, portal hypertensive complications, and HCC)

Secondary Outcome Measures

Cumulative and annual rate of patients with clinical events
Cumulative rate of patients with clinical events (death, liver transplantation, liver decompensation, portal hypertensive complications, and HCC)
Cumulative and annual incidence rate of HCC
Cumulative incidence rate of HCC
All-cause mortality
All-cause mortality
Cumulative and annual incidence rate of liver transplantation
Cumulative incidence rate of liver transplantation
Cumulative and annual incidence rate of liver decompensation
Cumulative incidence rate of liver decompensation
Cumulative and annual incidence rate of portal hypertensive complications
Cumulative incidence rate of portal hypertensive complications
Rate of receiving nucleos(t)ide analogue by meeting reimbursement criteria of treatment among Treatment ARM B subjects
Rate of receiving nucleos(t)ide analogue by meeting reimbursement criteria of treatment among Treatment ARM B subjects
Virologic response defined as HBV DNA less than 15 IU/mL
Virologic response defined as HBV DNA less than 15 IU/mL
Rate of ALT normalization
Rate of ALT normalization if baseline ALT is elevated
Rate of HBeAg seroclearance and seroconversion
Rate of HBeAg seroclearance and seroconversion among HBeAg-positive patients
Change of fibroscan
Change of fibroscan
Change of APRI index
Change of APRI index
Change of FIB-4
Change of FIB-4
Cumulative and annual incidence rate of HCC among HBeAg-positive or HBeAg-negative Patients
Cumulative incidence rate of HCC among HBeAg-positive or HBeAg-negative Patients
All cause-mortality among HBeAg-positive or HBeAg-negative
All cause-mortality among HBeAg-positive or HBeAg-negative
Cumulative and annual incidence rate of liver transplantation among HBeAg-positive or HBeAg-negative
Cumulative incidence rate of liver transplantation among HBeAg-positive or HBeAg-negative
Cumulative and annual incidence rate of liver decompensation among HBeAg-positive or HBeAg-negative
Cumulative incidence rate of liver decompensation among HBeAg-positive or HBeAg-negative
Cumulative and annual incidence rate of portal hypertensive complications among HBeAg-positive or HBeAg-negative
Cumulative incidence rate of portal hypertensive complications amongHBeAg-positive or HBeAg-negative
Cumulative and annual incidence rate of HCC among subjects according to baseline ALT level (normal ALT and elevated ALT)
Cumulative incidence rate of HCC amongsubjects according to baseline ALT level (normal ALT and elevated ALT)
All cause-mortality among subjects according to baseline ALT level (normal ALT and elevated ALT)
All cause-mortality among subjects according to baseline ALT level (normal ALT and elevated ALT)
Cumulative and annual incidence rate of liver transplantation among subjects according to baseline ALT level (normal ALT and elevated ALT)
Cumulative incidence rate of liver transplantation among subjects according to baseline ALT level (normal ALT and elevated ALT)
Cumulative and annual incidence rate of liver decompensation among subjects according to baseline ALT level (normal ALT and elevated ALT)
Cumulative incidence rate of liver decompensation among subjects according to baseline ALT level (normal ALT and elevated ALT)
Cumulative and annual incidence rate of portal hypertensive complications among subjects according to baseline ALT level (normal ALT and elevated ALT)
Cumulative incidence rate of portal hypertensive complications among subjects according to baseline ALT level (normal ALT and elevated ALT)
Cumulative and annual rate of patients with clinical events
Cumulative and annual rate of patients with clinical events (death, liver transplantation, liver decompensation, portal hypertensive complications, and HCC) after excluding patients who occurrs clinical events within 6 months of enrollment
Cumulative and annual rate of patients with clinical events
Cumulative and annual rate of patients with clinical events (death, liver transplantation, liver decompensation, portal hypertensive complications, and HCC) after excluding patients who occurrs clinical events within 12 months of enrollment
Cumulative and annual rate of patients with clinical events
Cumulative and annual rate of patients with clinical events (death, liver transplantation, liver decompensation, portal hypertensive complications, and HCC) in patients with normal ALT (<40 U/L) at the time of enrollment, after excluding patients who occurrs clinical events within 6 months of enrollment
Cumulative and annual rate of patients with clinical events
Cumulative and annual rate of patients with clinical events (death, liver transplantation, liver decompensation, portal hypertensive complications, and HCC) in patients with normal ALT (<40 U/L) at the time of enrollment, after excluding patients who occurrs clinical events within 12 months of enrollment

Full Information

First Posted
November 22, 2018
Last Updated
July 3, 2023
Sponsor
Young-Suk Lim
Collaborators
Samsung Medical Center, Kyunghee University Medical Center, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Seoul National University Hospital, Ulsan University Hospital, Konkuk University Medical Center, Kyungpook National University Hospital, Korea University Guro Hospital, Seoul St. Mary's Hospital, Kaohsiung Medical University, Chang Gung Memorial Hospital, E-DA Hospital, Taitung Mackay Memorial Hospital, National Cheng-Kung University Hospital, Chi Mei Medical Hospital, Chiayi Christian Hospital, St. Martin De Porress Hospital, Dalin Tzu Chi General Hospital, Taichung Veterans General Hospital, China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03753074
Brief Title
Effectiveness of TAF in Reducing Clinical Events in CHB Patients Beyond Treatment Indications by Current Guidelines
Acronym
ATTENTION
Official Title
A Multinational, Multicenter, Open-label, Randomized Controlled Trial to Investigate the Effectiveness of Tenofovir Alafenamide in Reducing Clinical Events in Chronic Hepatitis B Patients Beyond Treatment Indications by Current Guidelines
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 18, 2019 (Actual)
Primary Completion Date
December 31, 2031 (Anticipated)
Study Completion Date
December 31, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Young-Suk Lim
Collaborators
Samsung Medical Center, Kyunghee University Medical Center, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Seoul National University Hospital, Ulsan University Hospital, Konkuk University Medical Center, Kyungpook National University Hospital, Korea University Guro Hospital, Seoul St. Mary's Hospital, Kaohsiung Medical University, Chang Gung Memorial Hospital, E-DA Hospital, Taitung Mackay Memorial Hospital, National Cheng-Kung University Hospital, Chi Mei Medical Hospital, Chiayi Christian Hospital, St. Martin De Porress Hospital, Dalin Tzu Chi General Hospital, Taichung Veterans General Hospital, China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 ≤ log HBV-DNA IU/mL < 8) is expected to bring improvement in long-term clinical outcomes. This expected result may expand the treatment indications in patients with CHB based on age and HBV-DNA in contrast to current international guidelines of CHB.
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 treatment indications by current guidelines Study procedure: 780 subjects will be randomized in a 1:1 ratio (A:B) either to receive TAF 25 mg QD or to receive best supportive care after stratification according to the HBeAg status. The duration of maintaining both arms is 8 years. During treatment period, among treatment arm B, subjects who are indicated for antiviral treatment will be treated with TAF as follows: Based on the AASLD 2018 Guidelines of CHB (ALT 70≥ for male, 50≥ for female) 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. If they were clinically judged to have cirrhosis by investigators and confirmed with Fibroscan (≥ 12.0 kPa). Treatment Arm A: 390 subjects administered TAF 25 mg once daily Treatment Arm B: 390 subjects received best supportive care The primary analysis will occur at Year 4 with the primary endpoint being cumulative incidence rate of clinical events

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis b

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
780 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm A (TAF)
Arm Type
Experimental
Arm Description
390 subjects administered Tenofovir Alafenamide 25 mg once daily
Arm Title
Treatment Arm B (Best supportive care)
Arm Type
No Intervention
Arm Description
390 subjects received best supportive care During treatment period, among treatment arm B, subjects who are indicated for antiviral treatment will be treated with TAF as follows: Based on the AASLD 2018 Guidelines of CHB (ALT 70≥ for male, 50≥ for female) 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. If they were clinically judged to have cirrhosis by investigators and confirmed with Fibroscan (≥ 12.0 kPa).
Intervention Type
Drug
Intervention Name(s)
Tenofovir Alafenamide
Other Intervention Name(s)
Vemlidy
Intervention Description
Tenofovir Alafenamide 25mg, Tablet, Oral, Daily
Primary Outcome Measure Information:
Title
Cumulative rate of patients with clinical events
Description
Cumulative rate of patients with clinical events (death, liver transplantation, liver decompensation, portal hypertensive complications, and HCC)
Time Frame
At year 4
Secondary Outcome Measure Information:
Title
Cumulative and annual rate of patients with clinical events
Description
Cumulative rate of patients with clinical events (death, liver transplantation, liver decompensation, portal hypertensive complications, and HCC)
Time Frame
At year 4 and 8
Title
Cumulative and annual incidence rate of HCC
Description
Cumulative incidence rate of HCC
Time Frame
At year 4 and 8
Title
All-cause mortality
Description
All-cause mortality
Time Frame
At year 4 and 8
Title
Cumulative and annual incidence rate of liver transplantation
Description
Cumulative incidence rate of liver transplantation
Time Frame
At year 4 and 8
Title
Cumulative and annual incidence rate of liver decompensation
Description
Cumulative incidence rate of liver decompensation
Time Frame
At year 4 and 8
Title
Cumulative and annual incidence rate of portal hypertensive complications
Description
Cumulative incidence rate of portal hypertensive complications
Time Frame
At year 4 and 8
Title
Rate of receiving nucleos(t)ide analogue by meeting reimbursement criteria of treatment among Treatment ARM B subjects
Description
Rate of receiving nucleos(t)ide analogue by meeting reimbursement criteria of treatment among Treatment ARM B subjects
Time Frame
At year 4 and 8
Title
Virologic response defined as HBV DNA less than 15 IU/mL
Description
Virologic response defined as HBV DNA less than 15 IU/mL
Time Frame
At year 4 and 8
Title
Rate of ALT normalization
Description
Rate of ALT normalization if baseline ALT is elevated
Time Frame
At year 4 and 8
Title
Rate of HBeAg seroclearance and seroconversion
Description
Rate of HBeAg seroclearance and seroconversion among HBeAg-positive patients
Time Frame
At year 4 and 8
Title
Change of fibroscan
Description
Change of fibroscan
Time Frame
At year 4 and 8
Title
Change of APRI index
Description
Change of APRI index
Time Frame
At year 4 and 8
Title
Change of FIB-4
Description
Change of FIB-4
Time Frame
At year 4 and 8
Title
Cumulative and annual incidence rate of HCC among HBeAg-positive or HBeAg-negative Patients
Description
Cumulative incidence rate of HCC among HBeAg-positive or HBeAg-negative Patients
Time Frame
At year 4 and 8
Title
All cause-mortality among HBeAg-positive or HBeAg-negative
Description
All cause-mortality among HBeAg-positive or HBeAg-negative
Time Frame
At year 4 and 8
Title
Cumulative and annual incidence rate of liver transplantation among HBeAg-positive or HBeAg-negative
Description
Cumulative incidence rate of liver transplantation among HBeAg-positive or HBeAg-negative
Time Frame
At year 4 and 8
Title
Cumulative and annual incidence rate of liver decompensation among HBeAg-positive or HBeAg-negative
Description
Cumulative incidence rate of liver decompensation among HBeAg-positive or HBeAg-negative
Time Frame
At year 4 and 8
Title
Cumulative and annual incidence rate of portal hypertensive complications among HBeAg-positive or HBeAg-negative
Description
Cumulative incidence rate of portal hypertensive complications amongHBeAg-positive or HBeAg-negative
Time Frame
At year 4 and 8
Title
Cumulative and annual incidence rate of HCC among subjects according to baseline ALT level (normal ALT and elevated ALT)
Description
Cumulative incidence rate of HCC amongsubjects according to baseline ALT level (normal ALT and elevated ALT)
Time Frame
At year 4 and 8
Title
All cause-mortality among subjects according to baseline ALT level (normal ALT and elevated ALT)
Description
All cause-mortality among subjects according to baseline ALT level (normal ALT and elevated ALT)
Time Frame
At year 4 and 8
Title
Cumulative and annual incidence rate of liver transplantation among subjects according to baseline ALT level (normal ALT and elevated ALT)
Description
Cumulative incidence rate of liver transplantation among subjects according to baseline ALT level (normal ALT and elevated ALT)
Time Frame
At year 4 and 8
Title
Cumulative and annual incidence rate of liver decompensation among subjects according to baseline ALT level (normal ALT and elevated ALT)
Description
Cumulative incidence rate of liver decompensation among subjects according to baseline ALT level (normal ALT and elevated ALT)
Time Frame
At year 4 and 8
Title
Cumulative and annual incidence rate of portal hypertensive complications among subjects according to baseline ALT level (normal ALT and elevated ALT)
Description
Cumulative incidence rate of portal hypertensive complications among subjects according to baseline ALT level (normal ALT and elevated ALT)
Time Frame
At year 4 and 8
Title
Cumulative and annual rate of patients with clinical events
Description
Cumulative and annual rate of patients with clinical events (death, liver transplantation, liver decompensation, portal hypertensive complications, and HCC) after excluding patients who occurrs clinical events within 6 months of enrollment
Time Frame
At year 4 and 8
Title
Cumulative and annual rate of patients with clinical events
Description
Cumulative and annual rate of patients with clinical events (death, liver transplantation, liver decompensation, portal hypertensive complications, and HCC) after excluding patients who occurrs clinical events within 12 months of enrollment
Time Frame
At year 4 and 8
Title
Cumulative and annual rate of patients with clinical events
Description
Cumulative and annual rate of patients with clinical events (death, liver transplantation, liver decompensation, portal hypertensive complications, and HCC) in patients with normal ALT (<40 U/L) at the time of enrollment, after excluding patients who occurrs clinical events within 6 months of enrollment
Time Frame
At year 4 and 8
Title
Cumulative and annual rate of patients with clinical events
Description
Cumulative and annual rate of patients with clinical events (death, liver transplantation, liver decompensation, portal hypertensive complications, and HCC) in patients with normal ALT (<40 U/L) at the time of enrollment, after excluding patients who occurrs clinical events within 12 months of enrollment
Time Frame
At year 4 and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Young-Suk Lim, M.D, Ph D
Phone
+82-2-3010-5933
Email
limys@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Suk Lim, M.D, Ph D
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyungpook National University Hospital
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo Young Park, PhD
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young-Suk Lim, M.D., Ph.D.
Facility Name
Chung-Ang University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyung Joon Kim, PhD
Facility Name
Konkuk University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
So Young Kwon, PhD
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Hoon Kim, PhD
Facility Name
Kyung-Hee University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gi-Ae Kim, PhD
Facility Name
Samsung Medical center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myung Ji Goh, PhD
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun Bin Lee, PhD
Facility Name
The Catholic University of Korea, Seoul ST. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Withdrawn
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neung-Hwa Park, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
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Effectiveness of TAF in Reducing Clinical Events in CHB Patients Beyond Treatment Indications by Current Guidelines

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