Effectiveness of Antiviral Treatment in Cirrhotic Patients With Low-level Hepatitis B Virus DNA Levels (ATTACH)
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|ClinicalTrials.gov Identifier: NCT04780204|
Recruitment Status : Not yet recruiting
First Posted : March 3, 2021
Last Update Posted : March 4, 2021
Multicenter, Open-label, Randomized Controlled Trial Male and female adults with liver cirrhosis due to chronic hepatitis B virus infection who have low-level viremia and are beyond treatment indications by current guidelines.
To assess the efficacy of Tenofovir Alafenamide (TAF) in reducing liver-related events (hepatocellular carcinoma, liver-related events and death, decompensated liver cirrhosis) in cirrhotic chronic hepatitis B patients with low-level viremia beyond treatment indications by current guidelines, compared with best supportive care
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis B, Chronic||Drug: Treatment Drug: Observation of Hepatitis B||Phase 4|
This clinical trial is a multicenter, open label, randomized controlled study in cirrhotic chronic hepatitis B patients with low-level viremia beyond treatment indications by current guidelines.
Approximately 400 subjects meeting eligibility criteria will be enrolled and randomized (1:1) to Treatment Arm (A) or Observational Arm (B), as below:
- Treatment Arm (A): 200 subjects, TAF 25mg once daily with food for 3 years
- Observational Arm (B): 200 subjects, best supportive care for 3 years This study was designed to randomly assign treatment groups to subjects in order to prevent biases that may be intervened, and to increase comparability between the groups. Since HBeAg status could affect the clinical outcome in the eligible subjects, randomization will be stratified by HBeAg status (positive or negative) at screening at a 1:1 ratio by using centralized stratified block randomization.
Both groups (i.e. Treatment Arm and Observational Arm) are scheduled to be followed up to 3 years. When subjects in the Observational Arm group meets the treatment indications by current guidelines (HBV DNA ≥2,000 IU/mL or progressed to decompensated cirrhosis with detectable HBV DNA level), antiviral treatment will be initiated.
The primary endpoint will be analyzed with Kaplan-Meier methods and compared by the log-rank test between the two groups. Between-group comparisons of continuous or categorical baseline characteristics will be conducted using Student's t-test, Chi-square test or Fisher's exact test, as appropriate.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-label, Randomized Controlled Trial for the Effectiveness of Antiviral TreAtment in Cirrhotic Patients With Low-level Hepatitis B Virus DNA Levels (ATTACH)|
|Estimated Study Start Date :||August 2021|
|Estimated Primary Completion Date :||June 2025|
|Estimated Study Completion Date :||December 2025|
Experimental: Antiviral Treatment
Tenofovir Alafenamide 25mg once daily , Oral
Tenofovir Alafenamide 25 mg oral once daily
Other Name: Tenofovir alafenamide
Best supportive care
Drug: Observation of Hepatitis B
Best Supportive care
- cumulative incidence rate of composite clinical events [ Time Frame: From randomization the composite clinical events will be collected every 6weeks , assessed up to 36months ]hepatocellular carcinoma, death, liver transplantation, decompensated liver cirrhosis defined as Child-Pugh score ≥8, liver cirrhosis-related complications,liver-related unexpected hospital admission
- Cumulative incidence [ Time Frame: From randomization the composite clinical events will be collected every 1year , assessed up to 3years ]death, hepatocellular carcinoma , Liver transplantation, decompensated liver cirrhosis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780204
|Contact: Young-Suk Lim, PhDfirstname.lastname@example.org|
|Principal Investigator:||Young-Suk Lim, PhD||Asan Medical Center|