Status Approved
First Submitted Date
2021/02/10
Registered Date
2021/02/22
Last Updated Date
2024/02/08
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005927 |
---|---|
Unique Protocol ID | IN-KR-320-6132 |
Public/Brief Title | A Multicenter, Open-label, Single arm Trial for the Effectiveness of Antiviral TreAtment in Cirrhotic Patients with Low-level Hepatitis B Virus DNA Levels with a Comparison to Matched Historical Controls |
Scientific Title | A Multicenter, Open-label, Single arm Trial for the Effectiveness of Antiviral TreAtment in Cirrhotic Patients with Low-level Hepatitis B Virus DNA Levels with a Comparison to Matched Historical Controls |
Acronym | ATTACH |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | Yes |
Name of Registry / Registration Number | ClinicalTrials.gov-NCT04780204 |
Healthcare Benefit Approval Status | Submitted approval |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
---|---|
Board Approval Number | 2020-1615 |
Approval Date | 2020-10-29 |
Institutional Review Board Name | Asan Medical Center Institutional Review Board |
Institutional Review Board Address | 88, Olympic-ro 43-gil, Songpa-gu, Seoul |
Institutional Review Board Telephone | 02-3010-7166 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
---|---|
Name | Young-Suk Lim |
Title | Professor |
Telephone | +82-2-3010-3190 |
Affiliation | Asan Medical Center |
Address | 88, Olympic-ro 43-gil, Songpa-gu, Seoul, Korea |
Contact Person for Public Queries | |
Name | Dalnim Seo |
Title | Project Manager |
Telephone | +82-2-3010-7192 |
Affiliation | Asan Medical Center |
Address | 88, Olympic-ro 43-gil, Songpa-gu, Seoul, Korea |
Contact Person for Updating Information | |
Name | Dalnim Seo |
Title | Project Manager |
Telephone | +82-2-3010-7192 |
Affiliation | Asan Medical Center |
Address | 88, Olympic-ro 43-gil, Songpa-gu, Seoul, Korea |
4. Status
Study Site | Multi-center Number of center : 11 | |
---|---|---|
Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-08-23 Actual | |
Target Number of Participant | 400 | |
Primary Completion Date | 2025-12-31 , Anticipated | |
Study Completion Date | 2026-12-31 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Asan Medical Center | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-08-23 , | |
Recruitment Status by Participating Study Site 2 | ||
Name of Study | Samsung Medical Center | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-12-06 , | |
Recruitment Status by Participating Study Site 3 | ||
Name of Study | Kyung Hee University Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-09-09 , | |
Recruitment Status by Participating Study Site 4 | ||
Name of Study | Chung-Ang Univerisity Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2022-02-24 , | |
Recruitment Status by Participating Study Site 5 | ||
Name of Study | Seoul National University Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-12-02 , | |
Recruitment Status by Participating Study Site 6 | ||
Name of Study | Ulsan Univeristy Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-08-24 , | |
Recruitment Status by Participating Study Site 7 | ||
Name of Study | Konkuk University Medical Center | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-11-24 , | |
Recruitment Status by Participating Study Site 8 | ||
Name of Study | Kyungpook National University Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-08-23 , | |
Recruitment Status by Participating Study Site 9 | ||
Name of Study | Koera University Guro Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-12-17 , | |
Recruitment Status by Participating Study Site 10 | ||
Name of Study | The Catholic University of Korea, Seoul St. Mary's Hospital | |
Recruitment Status | Withdrawn Withdrawn Reason : 환자 등록이 매우 저조할 것으로 예상하여, 주관 기관과 협의 하에 조기 종료하기로 결정함 | |
Date of First Enrollment | 2023-12-31 , | |
Recruitment Status by Participating Study Site 11 | ||
Name of Study | Seoul National University Bundang Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2022-10-13 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
---|---|
Organization Name | Ministry of Health & Welfare |
Organization Type | Government |
Project ID | HC20C0062 |
6. Sponsor Organization
1. Sponsor Organization | |
---|---|
Organization Name | Asan Medical Center |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Collectively, the efficacy of antiviral treatment to improve long-term clinical outcome in cirrhotic CHB patients with low-level viremia (HBV DNA <2,000 IU/mL) has not been thoroughly evaluated. Considering that cirrhotic CHB patients with low-level viremia have considerably high risk of developing HCC in the previous retrospective study, the benefits of long-term antiviral treatment in these patients need further investigation. |
---|
8. Study Design
Study Type | Interventional Study |
---|---|
Study Purpose | Treatment |
Phase | Phase4 |
Intervention Model | Single Group |
Blinding/Masking | Open |
Allocation | Not Applicable |
Intervention Type | Drug |
Intervention Description | 1) This clinical trial is a multicenter, open label, single arm study in cirrhotic chronic hepatitis B patients with low-level viremia. 2) A total of 200 subjects meeting eligibility criteria will be enrolled and assigned to Treatment Arm (A) and 400 subjects from matched historical cohort will be compared to Treatment Arm. - Treatment Arm (A): 200 subjects, TAF 25mg once daily with food for 3 years - Matched Historical Controls Arm (B): 400 subjects, patients who did not receive antiviral treatment during their follow-up period, and were matched with the treatment group in a 1:2 ratio according to their baseline characteristics by propensity-score matching method 3) Treatment Arm is scheduled to be followed up to 3 years. |
Number of Arms | 1 |
Arm 1 |
Arm Label Treatment Arm |
Target Number of Participant 200 |
|
Arm Type Experimental |
|
Arm Description TAF 25mg once daily with food for 3 years |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (A00-B99)Certain infectious and parasitic diseases (B18.10)Chronic viral hepatitis B without delta-agent, immune-tolerant phase chronic hepatitis B |
---|---|
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 30Year~80Year |
|
Description 1) Willing and able to provide written informed consent prior to study entry 2) Age ≥30 years and ≤80 years at the time of screening 3) Chronic hepatitis B infection defined as HBsAg (+) or HBV DNA (+) for at least 6 months prior to the Screening visit, or medical records indication a chronic hepatitis B virus infection by meeting all of the following criteria at the time of screening. (1) HBsAg (+), (2) HBV DNA (+), and (3) HBcAb IgM (-) 4) Either HBeAg (+) or HBeAg (-) 5) Serum HBV DNA levels ≥20 IU/mL and <2,000 IU/mL at the time of screening 6) Evidence of liver cirrhosis defined as meeting any of the following criteria: - Radiological evidence of liver cirrhosis by ultrasound, CT, or MRI - Platelet count <150,000 /mm3 - Presence of esophageal or gastric varices by endoscopy in 2 years before the timing of screening - Clinically significant portal hypertension - Fibroscan ≥12.0 kPa (if the test was done in 6 months before the time of screening) 7) Estimated creatinine clearance ≥30 ml/min (by calculation of creatinine clearance or using the CKD-EPI equation) 8) Ability to comply with all study requirements |
|
Exclusion Criteria |
1) Confirmed known co-infection with HCV, HIV, or HDV 2) Current alcohol (60g/day) or substance abuse judged by the investigator that will potentially interfere with subject compliance 3) Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy, variceal hemorrhage, or Child-Pugh score of ≥8, with the exception of Gilbert syndrome) in 1 year before the time of screening 4) Currently on or have received therapy with Interferon or immunosuppressant (including systemic chemotherapy) within 12 months prior to the screening 5) Requirement for chronic use of systemic immunosuppressant including, but not limited to, corticosteroid (prednisone equivalent of >40 mg/day for >2 weeks), azathioprine, or monoclonal antibodies 6) Received solid organ or bone marrow transplant 7) History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs 8) Any other clinical conditions (cardiovascular, respiratory, neurologic, or renal conditions) or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements. 9) Currently on or have received antiviral treatment for ≥ 2 weeks within 6 months prior to the screening 10) History or current evidence of hepatocellular carcinoma (HCC), or high α-fetoprotein (AFP) > 20 ng/mL. But, the patients with AFP > 20 ng/mL can be enrolled if AFP shows decreasing trend and there is no evidence of HCC by dynamic CT or MRI) 11) Malignancy other than hepatocellular carcinoma within the 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (within 2 years prior to screening with confirmation of no evidence of disease). Subjects under evaluation for possible malignancy are not eligible. 12) Concurrent enrollment in another clinical study for other type of antiviral treatment for CHB or immune modulatory drug within 3 months prior to randomization, participation to an observational (non-interventional) clinical studies or interventional studies not using anti-HBV or immune modulatory drugs, or during the follow-up period of an interventional study are not exclusion criteria. 13) Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | The primary efficacy endpoint of this study is the cumulative incidence rate of composite clinical events including hepatocellular carcinoma, death, liver transplantation, decompensated liver cirrhosis defined as Child-Pugh score ≥8, liver cirrhosis-related complications (e.g., development of ascites, hepatic encephalopathy, gastroesophageal varix bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome, or sepsis), or liver-related unexpected hospital admission, in the full analysis set. |
|
Timepoint | for 3 years |
|
Secondary Outcome(s) 1 | ||
Outcome | Cumulative incidence of composite clinical events |
|
Timepoint | at year 1, 2, and 3 |
|
Secondary Outcome(s) 2 | ||
Outcome | Cumulative incidence of hepatocellular carcinoma |
|
Timepoint | at year 1, 2, and 3 |
11. Study Results and Publication
Result Registered | No |
---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
---|
TOP
BOTTOM
화면 최하단으로 이동