A Multicenter, Open-label, Prospective Cohort Study: The Potential Role of Serum HBV RNA Quantification in Optimizing Clinical Cure strategy in Chronic Hepatitis B Patients treaated with Nucleoside (Analogue) Analogues

• Register: ChiCTR
• Last refreshed on: 19 February 2018
• Main ID: ChiCTR1800014904
• Date of registration: 2018-02-14
• Prospective Registration: No
• Primary sponsor: Beijing Youan Hospital, Capital Medical University
• Public title: A Multicenter, Open-label, Prospective Cohort Study: The Potential Role of Serum HBV RNA Quantification in Optimizing Clinical Cure strategy in Chronic Hepatitis B Patients treaated with Nucleoside (Analogue) Analogues
• Scientific title: Clinical value of HBV RNA
• Date of first enrolment: 2018-02-11
• Target sample size: HBeAg positive :100;HBeAg negative:100;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=25202
• Study type: Relative factors research
• Study design: Cohort study
• Phase: Other

Countries of recruitment

China

Contacts

• Name: Sujun Zheng
• Affiliation: Beijing Youan Hospital, Capital Medical University

• Name: Yang Wang
• Affiliation: Beijing Youan Hospital, Capital Medical University

Key inclusion & exclusion criteria

Inclusion criteria: 1. Aged 18 to 60 years old;
2. liver function compensated (no history of ascites, hepatic encephalopathy or upper gastrointestinal bleeding);
3. pregnancy test of childbearing age women is negative;
4. HBeAg positive CHB before NAs treatment: NAs treatment= 12 months, HBV DNA was undetected=12 months (Roche diagnostic reagent kit was selected for screening, the lower limit of detection of HBV DNA was 20 IU/ml), HBeAg seroconversion had occurred =6 months, HBsAg <1500IU/ml, and ALT=1.5ULN;
5. HBeAg-negative CHB before initional of NAs treatment: NAs treatment=12 months, HBV DNA was undetected=12(Roche diagnostic reagent kit was selected for screening, the lower limit of detection of HBV DNA was 20 IU/m), HBsAg<1500 IU/ml and ALT=1.5 ULN;
6. fundus oculi examination was normal;
7. previously used interferon-alpha (Interferon-alpha, IFN-alpha) or PegIFN-alpha, the use of the last dose of interferon should be within a distance of 6 months or more;
8. obtain the informed consent of the subjects.
Exclusion criteria: 1. The telbivudine was included in the NAs antiviral regimen at enrollment;
2. Interleukin and its components are allergic;
3. neutrophils <1.5 × 10^9/L, or platelets <70×10^9/L;
4. simultaneous combined with other viral infection, such as hepatitis A, hepatitis C, hepatitis D, hepatitis E, HIV, etc .; or other causes of liver damage such as autoimmune liver disease, drug-induced liver injury, alcohol liver disease, hereditary hepatic disease, fatty liver disease, etc .;
5. in addition to hepatitis B, complicated with other serious physical and mental diseases, including uncontrolled primary kidney, heart, lung, vascular, neurological, digestive, metabolic (significant hyperthyroidism, severe diabetes and adrenal diseases), immunodeficiency diseases, severe infections and retinal diseases;
6. recent drug abuse or alcohol abuse history (6 months prior to screening), the researcher considered that influence the compliance of study protocol;
7. previous history of hepatocellular carcinoma, or screening of suspected hepatocellular carcinoma, such as: imaging found suspicious nodules, or AFP> 50ng/mL; or a history of suspected malignancy or malignancy over the past 5 years;
8. mental illness, uncontrollable epilepsy;
9. subjects receiving corticosteroid, immunosuppressive, and chemotherapeutic drugs within 6 months prior to enrollment;
10. Women with pregnancy, lactation and pregnancy planning during the study;
11. ultrasound or CT imaging examination indicated cirrhosis, or suggested any one of the following: LSM=12.0 kPa, or aspartate aminotransferase and platelet ratio index (APRI )> 2 points, or liver biopsy pathology in the most recent 1 year is indicative of cirrhosis;
12. receiving trial medication within the last 3 months;
13. serum total bilirubin> 2.0 ×ULN;
14. poor compliance;
15. researcher believe there are other conditions that may not suitable for inclusion.

Age minimum: 18
Age maximum: 60
Gender: Both

Health Condition(s) or Problem(s) studied

chronic hepatitis B

Intervention(s)

HBeAg positive :no;HBeAg negative:no;

Primary Outcome(s)

HBV RNA;

Secondary Outcome(s)

Hepatic histopathology;

Source(s) of Monetary Support

National Science and Technology Key Project on “Major Infectious Diseases such as HIV/AIDS, Viral Hepatitis Prevention and Treatment“(2017ZX10302201-004)

Ethics review

Status: Approved
Approval date: 11/02/2018
Contact:

Yumei Li

[phone]