Combined Therapy With Peginterferon Alfa-2a With NA in NA-treated HBeAg Positive Patients
NCT ID: NCT02474316
Last Updated: 2015-12-03
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
PHASE4
366 participants
INTERVENTIONAL
2014-08-31
2017-12-31
Brief Summary
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Arm A: Peginterferon alfa-2a 180μg /wk plus NA 1 piece qd for 48 weeks Arm B: Entecavir 0.5mg qd for 48 weeks
Detailed Description
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Arm A: Peginterferon alfa-2a 180μg /wk plus NA 1piece qd for 48 weeks Arm B:NA 1 piece qd for 48 weeks
The primary endpoint: HBeAg seroconversion at week 48
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PegINF plus nucleos(i)de analgoue
Peginterferon alfa-2a 180μg /wk plus nucleos(t)ide analgoue (NA) 1 piece qd for 48 weeks
Peginterferon alfa-2a
Peginterferon alfa-2a 180ug/wk s.c for 48 weeks
nucleos(t)ide analgoue
nucleos(t)ide analgoue (NA) 1 piece p.o for 48 weeks
nucleos(t)ide analgoue
nucleos(t)ide analgoue (NA) 1 piece qd for 48 weeks
nucleos(t)ide analgoue
nucleos(t)ide analgoue (NA) 1 piece p.o for 48 weeks
Interventions
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Peginterferon alfa-2a
Peginterferon alfa-2a 180ug/wk s.c for 48 weeks
nucleos(t)ide analgoue
nucleos(t)ide analgoue (NA) 1 piece p.o for 48 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. There should be evidences that HBsAg and HBeAg have been positive for more than 6 months with HBsAb and HBeAb negative before treated with Entecavir;
3. Treated with NA for more than 24 weeks and achieve HBV DNA\<1000copies/ml with HBeAb negative;
4. Women without ongoing pregnancy or breast feeding and willing to take an effective contraceptive measure during the treatment
5. Agree to participate in the study and sign the patient informed consent.
Exclusion Criteria
2. AFP\>50ng/ml and/or evidence of hepatocellular carcinoma
3. Evidence of decompensated liver disease (Child-Pugh scores \>5). Child-Pugh \>5 means that, if one of the following 6 conditions is met, the patient has to be excluded:
1. Serum albumin \<35 g/L;
2. Prothrombine time prolonged≥ 4 seconds or PTA \< 60%;
3. Serum bilirubin \> 34 µmol/L;
4. History of encephalopathy;
5. Ascites
4. 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)
5. Pregnant or breast-feeding Women
6. ANC\<1.5x 10\^9/L or PLT\<90x 10\^9/L
7. Consuming alcohol in excess of 20g/day for women and 30g/day for men within 6 months prior to enrollment
8. History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as major depression or psychosis that treated with antidepressant medication or a major tranquilizer at therapeutic doses respectively at any time prior to 3 months or any history of the following: a suicidal attempt hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
9. History of immunologically mediated disease, (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis etc.)
10. History of esophageal varices bleeding or other evidence of esophageal varices bleeding or other symptoms consistent with decompensated liver disease
11. History of chronic pulmonary disease associated with functional limitation
12. History of severe cardiac disease (e.g., NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases)
13. Hemodialysis patients or patients with renal insufficiency
14. History of a severe seizure disorder or current anticonvulsant use
15. Major organ transplantation or other evidence of severe illness, malignancy, or any other conditions, which would make the patient, in the opinion of the investigator, unsuitable for the study
16. History of thyroid disease poorly controlled on prescribed medications
17. Evidence of severe retinopathy or clinically relevant ophthalmologic disorder
18. History of other severe disease or evidence of other severe disease or any other illness or conditions that the investigator believe that patients are not suitable to join in the study
19. Immunomodulatory treatment (including interferon) or LDT within 1 year prior to the first dose of treatment
20. Patients included in another trial or having been given investigational drugs within 12 weeks prior to screening
18 Years
65 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Qing XIe
Director of infectious disease
Principal Investigators
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Qing Xie
Role: STUDY_CHAIR
Ruijin Hospital
Locations
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The Third People's Hospital of Guilin
Guilin, , China
Ruijin Hospital
Shanghai, , China
Shanghai Public Health Clinical Center
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Shuquan Chen, doctor
Role: primary
Qing Xie, doctor
Role: primary
Wei Cai, doctor
Role: backup
Liang Chen, doctor
Role: primary
References
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Lai CL, Ratziu V, Yuen MF, Poynard T. Viral hepatitis B. Lancet. 2003 Dec 20;362(9401):2089-94. doi: 10.1016/S0140-6736(03)15108-2.
Trepo C, Chan HL, Lok A. Hepatitis B virus infection. Lancet. 2014 Dec 6;384(9959):2053-63. doi: 10.1016/S0140-6736(14)60220-8. Epub 2014 Jun 18.
Tassopoulos NC, Volpes R, Pastore G, Heathcote J, Buti M, Goldin RD, Hawley S, Barber J, Condreay L, Gray DF. Efficacy of lamivudine in patients with hepatitis B e antigen-negative/hepatitis B virus DNA-positive (precore mutant) chronic hepatitis B. Lamivudine Precore Mutant Study Group. Hepatology. 1999 Mar;29(3):889-96. doi: 10.1002/hep.510290321.
Marcellin P, Chang TT, Lim SG, Tong MJ, Sievert W, Shiffman ML, Jeffers L, Goodman Z, Wulfsohn MS, Xiong S, Fry J, Brosgart CL; Adefovir Dipivoxil 437 Study Group. Adefovir dipivoxil for the treatment of hepatitis B e antigen-positive chronic hepatitis B. N Engl J Med. 2003 Feb 27;348(9):808-16. doi: 10.1056/NEJMoa020681.
Chang TT, Lai CL, Kew Yoon S, Lee SS, Coelho HS, Carrilho FJ, Poordad F, Halota W, Horsmans Y, Tsai N, Zhang H, Tenney DJ, Tamez R, Iloeje U. Entecavir treatment for up to 5 years in patients with hepatitis B e antigen-positive chronic hepatitis B. Hepatology. 2010 Feb;51(2):422-30. doi: 10.1002/hep.23327.
Brouwer WP, Xie Q, Sonneveld MJ, Zhang N, Zhang Q, Tabak F, Streinu-Cercel A, Wang JY, Idilman R, Reesink HW, Diculescu M, Simon K, Voiculescu M, Akdogan M, Mazur W, Reijnders JG, Verhey E, Hansen BE, Janssen HL; ARES Study Group. Adding pegylated interferon to entecavir for hepatitis B e antigen-positive chronic hepatitis B: A multicenter randomized trial (ARES study). Hepatology. 2015 May;61(5):1512-22. doi: 10.1002/hep.27586. Epub 2015 Feb 27.
Other Identifiers
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HOPE
Identifier Type: -
Identifier Source: org_study_id