Cirrhosis of Liver Due to Hepatitis B (Disorder) Clinical Trial
Official title:
Combination Treatment of Nucleoside （Acid）Analogue (NAs) and Pegylated Interferon α-2b for NAs Treated, Hepatitis B Related, Compensatory Cirrhosis Patients With Low Level Hepatitis b Virus Surface Antigen (HBsAg)
The study aims to demonstrate that whether treatment of nucleoside （acid）analogues (NAs) plus
pegylated interferon (Peg IFN) α-2b for those NAs treated, low level of HBsAg, hepatitis B
related compensatory cirrhosis patients will result in higher HBsAg clearance rate and reduce
the risk of liver cancer. The investigators plan to enroll about 84 hepatitis B related
compensatory cirrhosis patients, who have received NAs treatment more than 1 year with the
level of HBsAg <1000IU/ml. These participants will be devided into 2 groups. Group A will
receive the treatment of NAs plus Peg IFNα-2b. Group B will be treated with NAs as before
enrollment. The participants in both groups will be followed up for 96 weeks.
The primary endpoint is to compare the clearance rate of HBsAg between two groups. The
secondary endpoint includes: (1) comparing the incidence of liver cancer during the 96 weeks
follow-up, (2) comparing adverse side effects between the 2 groups. (3) comparing the
virological and biochemical responses between the 2 groups.
| Status | Recruiting |
| Enrollment | 84 |
| Est. completion date | May 30, 2024 |
| Est. primary completion date | May 30, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Aged 16-65 years old; Clinical diagnosis of compensatory cirrhosis; Child-Pugh grade A; Positive serum hepatitis B surface antigen (HBsAg); HBsAg titer < 1000IU/ml; Treated by nucleoside (acid)analogues (NAs) more than 1 year; HBV DNA <20 IU/ml; Negative serum hepatitis B e antigen (HBeAg); 15 minutes retention rate of indocyanine green <10%; The blood routine examination: 4×10e9/L<WBC<10×10e9/L?100×10e9/L<PLT<300×10e9/L. Exclusion Criteria: - Treated by interferon within half a year; Drug induce liver diseases; Autoimmune liver diseases; Liver diseases caused by metabolic factors; Superinfection with hepatitis A, C, D, E viruses; Infected by HIV virus; Severe respiratory diseases; Severe circulatory diseases, ; Severe digestive diseases; Severe neurological diseases; Need for immunosuppressive therapy for other diseases; Need for radiotherapy/chemotherapy for other diseases; Thyroid diseases; Rheumatic diseases; Malignant tumors; Severe varicose esophageal and gastric fundus veins; Mental or psychological disorders; Alcohol or drug abusers (average alcohol consumption >40g/d for men, >20g/d for women); With contraindications to interferon therapy; Pregnancy or having pregnancy plan in 3 years; Lactation; Can not comply with the study protocol; Fail to sign the informed consent; Other conditions that are not suitable for enrollment determined by researchers. |
| Country | Name | City | State |
|---|---|---|---|
| China | Third Affliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| Sun Yat-sen University |
China,
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* Note: There are 19 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The clearance rate of HBsAg for both groups during 96 weeks. | The clearance rate of HBsAg will be compared between 2 groups. | 96 weeks | |
| Secondary | The incidence rate of liver cancer for both groups during 96 weeks | The incidence of liver cancer will be compared between 2 groups. | 96 weeks | |
| Secondary | Occurance rate of adverse side effects in both groups | Adverse side effects, such as ascites, gastrointestinal bleeding, encephalopathy, hepatorenal syndrome will be compared between 2 groups | 96 weeks | |
| Secondary | The change of liver functions in both groups | The levels of alanine transaminase, glutamic-oxalacetic transaminase, albumin, total bilirubin, INR will be compared between the 2 groups. | 96 weeks | |
| Secondary | The change of blood routine test indexes in both groups | The levels of WBC, Hb, PLT will be compared between the 2 groups. | 96 weeks |