Real-world Study Optimizing Nucleotide-analogues

• Sponsor: Huashan Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05937178
• Collaborator: The First Affiliated Hospital of Anhui Medical University (Other), Anhui Provincial Hospital (Other), Beijing YouAn Hospital (Other), Peking University People's Hospital (Other), Peking University First Hospital (Other), Xiamen Hospital of Traditional Chinese Medicine (Other), First Affiliated Hospital of Fujian Medical University (Other), LanZhou University (Other), Third Affiliated Hospital, Sun Yat-Sen University (Other), First Affiliated Hospital of Guangxi Medical University (Other), The Affiliated Hospital Of Guizhou Medical University (Other), Hainan General Hospital (Other), Hebei Medical University Third Hospital (Other), The First Affiliated Hospital of Henan University of Traditional Chinese Medicine (Other), Henan Provincial People's Hospital (Other), The Second Affiliated Hospital of Harbin Medical University (Other), Tongji Hospital (Other), Wuhan Union Hospital, China (Other), Renmin Hospital of Wuhan University (Other), Central South University (Other), Xiangya Hospital of Central South University (Other), The First Hospital of Jilin University (Other), the Second Hospital of Nangjing (Other), The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other), The First Affiliated Hospital with Nanjing Medical University (Other), The Affiliated Hospital of Xuzhou Medical University (Other), The First Affiliated Hospital of Nanchang University (Other), Shengjing Hospital (Other), Qingdao Sixth People's Hospital (Other), Shandong Provincial Hospital Affiliated to Shandong First Medical University (Other), The Second Hospital of Shandong University (Other), The First Affiliated Hospital of Shanxi Medical University (Other), Tang-Du Hospital (Other), First Affiliated Hospital Xi'an Jiaotong University (Other), Ruijin Hospital (Other), West China Hospital (Other), Tianjin Second People's Hospital (Other), First Affiliated Hospital of Xinjiang Medical University (Other), The First People's Hospital of Yunnan (Other), Shulan (Hangzhou) Hospital (Other), Zhejiang University (Other), Southwest Hospital, China (Other), The Second Affiliated Hospital of Chongqing Medical University (Other), Sichuan Provincial People's Hospital (Other)
• Enrollment: 20,000
• Locations: 44
• Anticipated Duration (Months): 72
• Patients Per Site: 454.5
• Patients Per Site Per Month: 6.3

Study Details

Study Description

Brief Summary

The goal of this multicenter, observational, prospective study is to observe and compare different anti-viral treatment strategies in a real-world cohort of patients with CHB managed in routine clinical settings in China. The main questions it aims to answer are:

1. To evaluate the benefits of initiating first-line nucleos(t)ide analogue in patients with chronic HBV infection who are recommended in the updated Chinese Guideline 2022, but not recommended in the Chinese Guideline 2019.

2. To evaluate the Chinese Guideline recommends initiation of treatment, but at least one foreign authoritative guideline (eg. AASLD, EASL) does not recommend the benefit of initiating first-line nucleos(t)ide analogue in patients with chronic HBV infection who initiate treatment.

3. To compare the treatment effect of different alternatives with patients who have partial response after treatment with first-line nucleos(t)ide analogues.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B, Chronic	Drug: ETV/TAF/TDF/TMF/IFN; Drug: ETV/TAF/TDF/TMF

Detailed Description

REASON is a multicenter, observational, prospective study to explore an optimal anti-viral treatment in a real-world cohort of patients with CHB managed in routine clinical settings in China. The study will enroll treatment-naïve or treatment-experienced patients ≥18 and ≤80 years of age with hepatitis B s antigen positive. The treatment-experienced patients must be treated with monotherapy ETV/TDF/TAF/TMF continuously for a minimum of 48 weeks before enrollment. The treatment of participants will be decided before the screening by doctors based on the situation and patient's intention. When eligible patients are included in this study, no extra intervention will be conducted and only clinical data are collected and observed. Participants will enter different observation groups when they meet the eligibility criteria of each group listed below: Group A：treatment-naive, and meeting the conditions that are recommended to initiate treatment in 2022 Chinese Guideline but not in 2019 Chinese Guideline; Group B：treatment-naive, meeting the conditions that are recommended to initiate treatment in both 2019 and 2022 Chinese guideline, but not in AASLD/EASL guidelines; Group C: treatment-experienced and with partial response. The primary efficacy endpoint was the proportion of patients with HBV DNA less than 20 IU/ml at 48 weeks, 96 weeks, and 144 weeks. Participants in all groups will be stratified by whether they initiate treatment in Group A and B, and by the treatment regimens in Group C. The primary safety outcome is the change from baseline in the Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) at 48 weeks, 96 weeks, and 144 weeks. The secondary outcomes including HBsAg loss, HBsAg seroconversion, HBeAg loss, HBeAg seroconversion, fibrosis regression and progression, and liver-related events, which will be measured at each follow-up visit. The follow-up time course of this study will be 3 years.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Real-world Study of Optimizing Nucleotide-analogues-based Treatment for Chronic Hepatitis B
• Actual Study Start Date: Jan 31, 2023
• Anticipated Primary Completion Date: Jan 31, 2029
• Anticipated Study Completion Date: Jan 31, 2029

Arms and Interventions

Arm	Intervention/Treatment
Recommend to initiate treatment in 2022 Chinese Guideline, but not in 2019 Chinese Guideline Untreated population who does not be recommended to initiate treatment in 2022 Chinese Guideline, but not in 2019 Chinese Guideline. The initate treatment is to receive a first-line nucleos(t)ide analogue, i.e., entecavir, tenofovir disoproxil, or tenofovir alafenamide, tenofovir amibufenamide	Drug: ETV/TAF/TDF/TMF; peginterferon alpha or nucleos(t)ide alone are decided by patients' doctors according to their conditions, instead of extra interventions brought by the study
Recommend to initiate treatment in 2019 and 2022 Chinese Guideline, but not in AASLD/EASL guidelines Untreated population will receive a first-line nucleos(t)ide analogue , i.e., entecavir, tenofovir disoproxil, or tenofovir alafenamide, tenofovir amibufenamide, and the population should meet the conditions that are recommended to initiate treatment in 2019 and 2022 Chinese guideline, but not in AASLD/EASL guidelines	Drug: ETV/TAF/TDF/TMF; peginterferon alpha or nucleos(t)ide alone are decided by patients' doctors according to their conditions, instead of extra interventions brought by the study
Treatment experienced and with partial response Treatment experienced population who has received a first-line nucleos(t)ide analogue(NA) as monotherapy at least 48 weeks, i.e., entecavir, tenofovir disoproxil, or tenofovir alafenamide, tenofovir amibufenamide, and has partial response to NA. They will continue the original therpay or plans to change the therapy (e.g. switch another first-line NA, add-on another first-line NA, switch another first-line NA and add-on peginterferon alpha)	Drug: ETV/TAF/TDF/TMF/IFN; peginterferon alpha or nucleos(t)ide alone are decided by patients' doctors according to their conditions, instead of extra interventions brought by the study

Outcome Measures

Primary Outcome Measures

1. The proportion of patients with HBV DNA <20 IU/ml [Week 48]

   The primary efficacy endpoint was the proportion of patients with HBV DNA <20 IU/ml at each follow-up time point, as determined by high-sensitivity PCR

2. The proportion of patients with HBV DNA <20 IU/ml [Week 96]

   The primary efficacy endpoint was the proportion of patients with HBV DNA <20 IU/ml at each follow-up time point, as determined by high-sensitivity PCR

3. The proportion of patients with HBV DNA <20 IU/ml [Week 144]

   The primary efficacy endpoint was the proportion of patients with HBV DNA <20 IU/ml at each follow-up time point, as determined by high-sensitivity PCR

4. Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) [Baseline]

   Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) at each follow-up time point

5. Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) [Week 48]

   Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) at each follow-up time point

6. Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) [Week 96]

   Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) at each follow-up time point

7. Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) [Week 144]

   Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) at each follow-up time point

Secondary Outcome Measures

1. Proportion of participants with Normal Alanine Aminotransferase (ALT) [Week 48, Week 96 and Week 144]

   Proportion of participants with Normal Alanine Aminotransferase (ALT) at each follow-up time point

2. Proportion of participants with Hepatitis B s Antigen (HBsAg) Loss [Week 48, Week 96 and Week 144]

   Proportion of participants with Hepatitis B s Antigen (HBsAg) Loss at each follow-up time point

3. Proportion of participants with Hepatitis B s Antigen (HBeAg) Loss [Week 48, Week 96 and Week 144]

   Proportion of participants with Hepatitis B s Antigen (HBeAg) Loss at each follow-up time point

4. Proportion of participants with seroconversion to Hepatitis B s Antigen (HBsAg) [Week 48, Week 96 and Week 144]

   Proportion of participants with seroconversion to Hepatitis B s Antigen (HBsAg) at each follow-up time point

5. Proportion of participants with seroconversion to Hepatitis B e Antigen (HBeAg) [Week 48, Week 96 and Week 144]

   Proportion of participants with seroconversion to Hepatitis B e Antigen (HBeAg) at each follow-up time point

6. Proportion of participants with fibrosis regression and progression [Week 48, Week 96 and Week 144]

   Proportion of participants with fibrosis regression and progression at each follow-up time point

7. Rate of liver-related events [Week 48, Week 96 and Week 144]

   Rate of liver-related events (HCC, decompensation cirrhosis, death) at each follow-up time point

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• CHB defined as positive hepatitis B surface antigen at least 6 months, or HBV-related histological changes within 1 year if HBsAg positive less than 6 months.

• Age between 18-80 years.

• Patient who reads and signs informed consent.

• Meet any conditions of the group listed below

Group A-naïve and meeting the conditions that are recommended to initiate treatment in 2022 Chinese Guideline, but not in 2019 Chinese Guideline (observe-plan to treat or control-plan to follow-up) :

1. HBV DNA positive, ALT is continuously upper limit of normal (male 30 U/L, female 19 U/L)
2. HBeAg positive, HBV DNA≤2×10^{7 IU/ml; HBeAg negative, HBV DNA≥2×10}3 IU/ml C. Meet any of the conditions listed below

1. Age>30 years, and have a family history of cirrhosis or HCC, TE indicates no significant fibrosis;

2. Family history of cirrhosis or HCC, and ≤30 years, TE indicates no significant fibrosis;

3. TE indicates significant fibrosis, and ≤30 years, without family history of cirrhosis or HCC

Group B-naïve and meeting the conditions that are recommended to initiate treatment in both 2019 and 2022 Chinese Guidelines, but not in EASL or AASLD guideline (observe-plan to treat or control-plan to follow-up) :

1. Without cirrhosis, HBV DNA≤2000 IU/ml, ALT>1 ULN； B. Without cirrhosis, HBV DNA>2000 IU/ml, 1 ULN<ALT≤2 ULN； C. Without cirrhosis, normal ALT, >30 years, have a family history of cirrhosis or HCC, or TE indicates significant fibrosis; D. Without cirrhosis, HBV DNA 20-2000 IU/ml Group C-experienced and partial response (1. switch another first-line NA; 2. add-on another first-line NA; 3. switch another first-line NA and add-on peginterferon alpha; 4. continue the original plan) Treatment experienced patient who has received a first-line nucleos(t)ide analogue(NA) monotherapy for at least 48 weeks, i.e., entecavir, tenofovir disoproxil or tenofovir alafenamide, tenofovir amibufenamide, and has partial response. They plan to continue or change the therapy

Exclusion Criteria:

• Have poor compliance;

• Received contraindicated concomitant drugs (subjects receiving prohibited drugs will need at least 30 days of washing out period) and known hypersensitivity reactions to the study drug, metabolites, or formulated excipients;

• Any other clinical symptoms or previous treatment that the investigator considers that the individual subject is not suitable for this study or cannot comply with the administration requirements

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anhui Provincial Hospital	Hefei	Anhui	China	230000
2	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui	China	230000
3	Beijing YouAn Hospita	Beijing	Beijing	China	100000
4	Peking University First Hospital	Beijing	Beijing	China	100000
5	Peking University People's Hospital	Beijing	Beijing	China	100000
6	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing	China	400000
7	the Southwest Hospital of AMU	Chongqing	Chongqing	China	400000
8	First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian	China	350000
9	Xiamen Hospital of Traditional Chinese Medicine	Xiamen	Fujian	China	361000
10	the First Hospital of Lanzhou University	Lanzhou	Gansu	China	730000
11	First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi	China	530000
12	The Affiliated Hospital Of Guizhou Medical University	Guiyang	Guizhou	China	55000
13	The Second Affiliated Hospital of Harbin Medical University	Ha'erbin	Ha'erbin	China	150000
14	Hainan General Hospital	Haikou	Hainan	China	570100
15	the Third Hospital of Hebei Medical University	Shijiazhuang	Hebei	China	050000
16	Henan Provincial People's Hospital	Zhengzhou	Henan	China	450000
17	The First Affiliated Hospital of Henan University of Traditional Chinese Medicine	Zhengzhou	Henan	China	450000
18	Renmin Hospital of Wuhan University	Wuhan	Hubei	China	430000
19	Tongji Hospital	Wuhan	Hubei	China	430000
20	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China	430000
21	the Second Xiangya Hospital of Central South University	Changsha	Hunan	China	430100
22	Xiangya Hospital Central South University	Changsha	Hunan	China	430100
23	Jiangsu Province Hospital	Nanjing	Jiangsu	China	210000
24	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu	China	210000
25	the Second Hospital of Nangjing	Nanjing	Jiangsu	China	210000
26	the Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu	China	221000
27	the First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	China	330000
28	the First Bethune Hospital Of Jilin University	Chang chun	Jilin	China	130000
29	Shengjing Hospital of China Medical University	Shenyang	Liaoning	China	110000
30	Tangdu Hospital, The Fourth Military Medical University	Xi'an	Shaanxi	China	710000
31	the First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi	China	710000
32	Shandong Provincial Hospital Affiliated to Shandong First Medical University	Jinan	Shandong	China	250000
33	The Second Hospital of Shandong University	Jinan	Shandong	China	250000
34	No. 6 People's Hospital of Qingdao	Qingdao	Shandong	China	266000
35	Ruijin Hospital	Shanghai	Shanghai	China	200000
36	First Hospital of Shanxi Medical University	Taiyuan	Shanxi	China	030000
37	Sichuan Provincial People's Hospital	Chengdu	Sichuan	China	610000
38	West China Hospital of Sichuan University	Chengdu	Sichuan	China	610000
39	Tianjin Second People's Hospital	Tianjin	Tianjin	China	300000
40	Third Affiliated Hospital, Sun Yat-Sen University	Meizhou	Xiamen	China	514000
41	Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine	Ürümqi	Xinjiang Uygur Autonomous Region	China	830000
42	First People's Hospital of Yunnan Province	Kunming	Yunnan	China	650000
43	Shulan (Hangzhou) Hospital	Hangzhou	Zhejiang	China	310000
44	Huashan Hospital	Shanghai		China	200040

Sponsors and Collaborators

• Huashan Hospital
• The First Affiliated Hospital of Anhui Medical University
• Anhui Provincial Hospital
• Beijing YouAn Hospital
• Peking University People's Hospital
• Peking University First Hospital
• Xiamen Hospital of Traditional Chinese Medicine
• First Affiliated Hospital of Fujian Medical University
• LanZhou University
• Third Affiliated Hospital, Sun Yat-Sen University
• First Affiliated Hospital of Guangxi Medical University
• The Affiliated Hospital Of Guizhou Medical University
• Hainan General Hospital
• Hebei Medical University Third Hospital
• The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
• Henan Provincial People's Hospital
• The Second Affiliated Hospital of Harbin Medical University
• Tongji Hospital
• Wuhan Union Hospital, China
• Renmin Hospital of Wuhan University
• Central South University
• Xiangya Hospital of Central South University
• The First Hospital of Jilin University
• the Second Hospital of Nangjing
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• The First Affiliated Hospital with Nanjing Medical University
• The Affiliated Hospital of Xuzhou Medical University
• The First Affiliated Hospital of Nanchang University
• Shengjing Hospital
• Qingdao Sixth People's Hospital
• Shandong Provincial Hospital Affiliated to Shandong First Medical University
• The Second Hospital of Shandong University
• The First Affiliated Hospital of Shanxi Medical University
• Tang-Du Hospital
• First Affiliated Hospital Xi'an Jiaotong University
• Ruijin Hospital
• West China Hospital
• Tianjin Second People's Hospital
• First Affiliated Hospital of Xinjiang Medical University
• The First People's Hospital of Yunnan
• Shulan (Hangzhou) Hospital
• Zhejiang University
• Southwest Hospital, China
• The Second Affiliated Hospital of Chongqing Medical University
• Sichuan Provincial People's Hospital

Investigators

• Principal Investigator: Wenghong Zhang, MD, Huashan Hospital
• Principal Investigator: Jiming Zhang, MD, Huashan Hospital
• Study Chair: Feng S, MD, Huashan Hospital
• Study Director: Qiran Zhang, MD, Huashan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• Agarwal K, Brunetto M, Seto WK, Lim YS, Fung S, Marcellin P, Ahn SH, Izumi N, Chuang WL, Bae H, Sharma M, Janssen HLA, Pan CQ, Celen MK, Furusyo N, Shalimar D, Yoon KT, Trinh H, Flaherty JF, Gaggar A, Lau AH, Cathcart AL, Lin L, Bhardwaj N, Suri V, Mani Subramanian G, Gane EJ, Buti M, Chan HLY; GS-US-320-0110; GS-US-320-0108 Investigators. 96 weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection. J Hepatol. 2018 Apr;68(4):672-681. doi: 10.1016/j.jhep.2017.11.039. Epub 2018 Jan 17.
• Chinese Society of Hepatology, Chinese Medical Association. [Expert opinion on expanding anti-HBV treatment for chronic hepatitis B]. Zhonghua Gan Zang Bing Za Zhi. 2022 Feb 20;30(2):131-136. doi: 10.3760/cma.j.cn501113-20220209-00060. Chinese.
• Chinese Society of Infectious Disease Chinese Society of Hepatology; Chinese Medical Association. [The expert consensus on clinical cure (functional cure) of chronic hepatitis B]. Zhonghua Gan Zang Bing Za Zhi. 2019 Aug 20;27(8):594-603. doi: 10.3760/cma.j.issn.1007-3418.2019.08.003. Chinese.
• Chinese Society of Infectious Diseases, Chinese Medical Association; Chinese Society of Hepatology, Chinese Medical Association. [The guidelines of prevention and treatment for chronic hepatitis B (2019 version)]. Zhonghua Gan Zang Bing Za Zhi. 2019 Dec 20;27(12):938-961. doi: 10.3760/cma.j.issn.1007-3418.2019.12.007. Chinese.
• European Association for the Study of the Liver. Electronic address: [e-mail]; European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017 Aug;67(2):370-398. doi: 10.1016/j.jhep.2017.03.021. Epub 2017 Apr 18.
• Kim GA, Lim YS, An J, Lee D, Shim JH, Kim KM, Lee HC, Chung YH, Lee YS, Suh DJ. HBsAg seroclearance after nucleoside analogue therapy in patients with chronic hepatitis B: clinical outcomes and durability. Gut. 2014 Aug;63(8):1325-32. doi: 10.1136/gutjnl-2013-305517. Epub 2013 Oct 25.
• Lim TH, Gane E, Moyes C, Borman B, Cunningham C. HBsAg loss in a New Zealand community study with 28-year follow-up: rates, predictors and long-term outcomes. Hepatol Int. 2016 Sep;10(5):829-37. doi: 10.1007/s12072-016-9709-6. Epub 2016 Mar 8.
• Nassal M. HBV cccDNA: viral persistence reservoir and key obstacle for a cure of chronic hepatitis B. Gut. 2015 Dec;64(12):1972-84. doi: 10.1136/gutjnl-2015-309809. Epub 2015 Jun 5.
• National Health and Family Planning Commission of the People's Republic of China. China Statistical Yearbook. Beijing: Peking Union Medical College Press, 2020.
• Polaris Observatory Collaborators. Global prevalence, treatment, and prevention of hepatitis B virus infection in 2016: a modelling study. Lancet Gastroenterol Hepatol. 2018 Jun;3(6):383-403. doi: 10.1016/S2468-1253(18)30056-6. Epub 2018 Mar 27.
• Sinn DH, Kim SE, Kim BK, Kim JH, Choi MS. The risk of hepatocellular carcinoma among chronic hepatitis B virus-infected patients outside current treatment criteria. J Viral Hepat. 2019 Dec;26(12):1465-1472. doi: 10.1111/jvh.13185. Epub 2019 Aug 13.
• Terrault NA, Lok ASF, McMahon BJ, Chang KM, Hwang JP, Jonas MM, Brown RS Jr, Bzowej NH, Wong JB. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018 Apr;67(4):1560-1599. doi: 10.1002/hep.29800. No abstract available.
• Wang G, Duan Z. Guidelines for Prevention and Treatment of Chronic Hepatitis B. J Clin Transl Hepatol. 2021 Oct 28;9(5):769-791. doi: 10.14218/JCTH.2021.00209. Epub 2021 Sep 28.
• Zhang L, Fan ZF, Liu DW, Zhou MG, Wang ZQ, Li M. [Trend analysis on the disease burden related to cirrhosis and other chronic liver diseases caused by hepatitis B, in China, from 1990 to 2016]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):173-177. doi: 10.3760/cma.j.issn.0254-6450.2020.02.007. Chinese.
• ZHUANG H. Should chronic hepatitis B in the indeterminate phase be treated?[J]. J Clin Hepatol, 2021, 37(9): 2033-2036.

• Responsible Party: Wen-hong Zhang, Director of Division of Infectious Diseases, Huashan Hospital
• ClinicalTrials.gov Identifier: NCT05937178
• Other Study ID Numbers: REASON
• First Posted: Jul 10, 2023
• Last Update Posted: Jul 10, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis

Study Results

No Results Posted as of Jul 10, 2023