A Prospective Clinical Trial in Chronic Hepatitis B Patients NAs (Nucleotides or Nucleosides) Experienced (Anchor Study)
NCT ID: NCT02327416
Last Updated: 2016-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
300 participants
INTERVENTIONAL
2014-10-31
2019-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1,conventional control group
Drug: Entecavir and or adefovir dipivoxil are used for 96 weeks and the follow up 24 weeks. Entecavir 0.5mg po daily or plus ADV （adefovir dipivoxil）10mg po daily.
Entecavir and or adefovir dipivoxil
In arm 1, Entecavir and or adefovir dipivoxil are used for 96 weeks and the follow up 24 weeks as conventional control, In arm 2 and 3, Entecavir and or adefovir dipivoxil are used for 48 weeks.
2，combination and sequential group
Drug: Y peginterferon Alfa-2b 180 micrograms sc/week for 96 weeks; Drug: Entecavir and or adefovir dipivoxil are used for 48 weeks. Entecavir 0.5mg po daily for 48 weeks or plus ADV 10mg po daily.
Y peginterferon alfa-2b
In arm 2 and 3, Y peginterferon alfa-2b is used for 96 weeks
Entecavir and or adefovir dipivoxil
In arm 1, Entecavir and or adefovir dipivoxil are used for 96 weeks and the follow up 24 weeks as conventional control, In arm 2 and 3, Entecavir and or adefovir dipivoxil are used for 48 weeks.
3, multitarget group
Drug: Y peginterferon Alfa-2b 180 micrograms sc/week for 96 weeks; Drug: Granulocyte-macrophage colony stimulating factor is used for 48 weeks; Drug: Entecavir and or adefovir dipivoxil are used for 48 weeks. Entecavir 0.5mg po daily for 48 weeks or plus ADV 10mg po daily.
Y peginterferon alfa-2b
In arm 2 and 3, Y peginterferon alfa-2b is used for 96 weeks
Granulocyte-macrophage colony stimulating factor
In arm 3, Granulocyte-macrophage colony stimulating factor is used for 48 weeks intermittently
Entecavir and or adefovir dipivoxil
In arm 1, Entecavir and or adefovir dipivoxil are used for 96 weeks and the follow up 24 weeks as conventional control, In arm 2 and 3, Entecavir and or adefovir dipivoxil are used for 48 weeks.
Interventions
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Y peginterferon alfa-2b
In arm 2 and 3, Y peginterferon alfa-2b is used for 96 weeks
Granulocyte-macrophage colony stimulating factor
In arm 3, Granulocyte-macrophage colony stimulating factor is used for 48 weeks intermittently
Entecavir and or adefovir dipivoxil
In arm 1, Entecavir and or adefovir dipivoxil are used for 96 weeks and the follow up 24 weeks as conventional control, In arm 2 and 3, Entecavir and or adefovir dipivoxil are used for 48 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. HBsAg positive, entecavir and or adefovir dipivoxil are used at least 1 year including patients with nucleotides or nucleoside resistance history if their HBV DNA obtained control;
3. Before nucleotides or nucleosides treatment, ALT \> 2 ULN, HBV DNA \>10000 copies/ml,HBsAg positive;
4. Serum HBV DNA \< 1000 copies/ml;
5. Serum HBsAg \< 3000 IU/ml;
6. HBsAg positive;
7. Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug;
8. Absence of cirrhosis confirmed by ultrasonic test;
9. Agree to participate in the study and sign the patient informed consent.
Exclusion Criteria
2. Other antiviral, anti-neoplastic or immunomodulatory treatment (including supra physiologic doses of steroids and radiation) 6 months prior to the first dose of randomized treatment (except for 7 days of acyclovir for herpetic lesions more than 1 month prior to first administration of randomized treatment). Patients who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation are also excluded;
3. Women with ongoing pregnancy or breast-feeding;
4. Co-infection with active hepatitis A, hepatitis C, hepatitis D(Those hospitals which have the ability to do the test will do) and/or human immunodeficiency virus (HIV);
5. ALT \>10 ULN;
6. Evidence of decompensated liver disease (Child-Pugh score \> 5 ). Child-Pugh \> 5 means, if one of the following 5 conditions are met, the patient has to be excluded:
one of the following 5 conditions are met, the patient has to be excluded:
1. Serum albumin \< 3.5 g/L;
2. Prothrombin time \> 3 seconds prolonged;
3. Serum bilirubin \> 34 µ mol/L;
4. History of encephalopathy;
5. History of variceal bleeding;
6. Ascites;
7. History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures, thalassemia);
8. Signs or symptoms of hepatocellular carcinoma, patients with a value of alpha-fetoprotein \> 100 ng/mL are excluded, unless stability (less than 10% increase) has been documented over at least the previous 3 months. Patients with values \< 20 ng/mL but \> 100 ng/mL may be enrolled, if hepatic neoplasia has been excluded by liver imaging;
9. Neutrophil count \< 1500 cells/mm3 or platelet count \<90,000 cells/mm3 at screening;
10. Hemoglobin \< 11.5 g/dL for females and \<12.5 g/dL for men;
11. Serum creatinine level \> 1.5 ULN in screening period.
12. Phosphorus \< 0.65 mmol/L;
13. ANA \> 1:100;
14. History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease;
15. History of a severe seizure disorder or current anticonvulsant use;
16. History of immunologically mediated disease, (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis etc.);
17. History of chronic pulmonary disease associated with functional limitation;
18. Diseases that IFN and Nucleotides or nucleosides are not suitable.
18 Years
65 Years
ALL
No
Sponsors
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Xiamen Amoytop Biotech Co., Ltd.
INDUSTRY
Tongji Hospital
OTHER
Responsible Party
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Qin Ning
Director and Chair of Department of Infectious Diseases
Principal Investigators
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Qin Ning, Doctor
Role: PRINCIPAL_INVESTIGATOR
Department of Infectious Diseases, Tongji Hospital
Locations
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Beijing Youan Hospital
Beijing, Beijing Municipality, China
Tongji Hospital
Wuhan, Hubei, China
Xiangya Hospital, Central South University
Changsha, Hunan, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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References
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Gu M, Wu W, You J, Wu Q, Huang F, Zhang Y, Wang P, Xi D, Yan W, Wang X, Chen T, Wu D, Ning Q, Han M. High-Throughput Viral Integration Detection Reveals Baseline Breakpoints Burden Associated With HBsAg Seroclearance. Aliment Pharmacol Ther. 2025 Jul 16. doi: 10.1111/apt.70270. Online ahead of print.
Huang D, Wu D, Wang P, Wang Y, Yuan W, Hu D, Hu J, Wang Y, Tao R, Xiao F, Zhang X, Wang X, Han M, Luo X, Yan W, Ning Q. End-of-treatment HBcrAg and HBsAb levels identify durable functional cure after Peg-IFN-based therapy in patients with CHB. J Hepatol. 2022 Jul;77(1):42-54. doi: 10.1016/j.jhep.2022.01.021. Epub 2022 Feb 8.
Other Identifiers
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Anchor study
Identifier Type: -
Identifier Source: org_study_id
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