- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02474316
Combined Therapy With Peginterferon Alfa-2a With NA in NA-treated HBeAg Positive Patients
A Prospective, Randomized, Multicenter, Open-label Study Evaluating HBeAg Seroconversion in HBeAg Positive CHB Patients on Treatment With NA Switched to Combined Therapy With Peginterferon Alfa-2a and NA for 48 Weeks
This is a prospective, randomized, multicenter, open-label study. After more than 24 weeks NA treatment, HBeAg positive CHB patients who achieved HBV DNA<1000copies/ml but HBeAb negative, will be randomized (1:1) into 2 study arms as follows:
Arm A: Peginterferon alfa-2a 180μg /wk plus NA 1 piece qd for 48 weeks Arm B: Entecavir 0.5mg qd for 48 weeks
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This is a prospective, randomized, multicenter, open-label study. After more than 24 weeks NA treatment, HBeAg positive CHB patients who achieved HBV DNA<1000copies/ml but HBeAb negative, will be randomized (1:1) into 2 study arms as follows:
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
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 4
Kontakter och platser
Studiekontakt
- Namn: Qing Xie
- Telefonnummer: 86-13651804273
- E-post: xieqingrjh2015@gmail.com
Studieorter
-
-
-
Guilin, Kina
- Rekrytering
- The Third People's Hospital of Guilin
-
Kontakt:
- Shuquan Chen, doctor
-
Shanghai, Kina
- Rekrytering
- Ruijin Hospital
-
Kontakt:
- Qing Xie, doctor
-
Kontakt:
- Wei Cai, doctor
-
Shanghai, Kina
- Rekrytering
- Shanghai Public Health Clinical Center
-
Kontakt:
- Liang Chen, doctor
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion criteria:
- Male and female patients with age ≥18 and ≤65 years;
- 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;
- Treated with NA for more than 24 weeks and achieve HBV DNA<1000copies/ml with HBeAb negative;
- Women without ongoing pregnancy or breast feeding and willing to take an effective contraceptive measure during the treatment
- Agree to participate in the study and sign the patient informed consent.
Exclusion Criteria:
- Co-infection with active hepatitisA, hepatitisC, hepatitisD and/or human immunodeficiency virus (HIV)
- AFP>50ng/ml and/or evidence of hepatocellular carcinoma
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:
- Serum albumin <35 g/L;
- Prothrombine time prolonged≥ 4 seconds or PTA < 60%;
- Serum bilirubin > 34 µmol/L;
- History of encephalopathy;
- Ascites
- 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)
- Pregnant or breast-feeding Women
- ANC<1.5x 10^9/L or PLT<90x 10^9/L
- Consuming alcohol in excess of 20g/day for women and 30g/day for men within 6 months prior to enrollment
- 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
- History of immunologically mediated disease, (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis etc.)
- History of esophageal varices bleeding or other evidence of esophageal varices bleeding or other symptoms consistent with decompensated liver disease
- History of chronic pulmonary disease associated with functional limitation
- 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)
- Hemodialysis patients or patients with renal insufficiency
- History of a severe seizure disorder or current anticonvulsant use
- 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
- History of thyroid disease poorly controlled on prescribed medications
- Evidence of severe retinopathy or clinically relevant ophthalmologic disorder
- 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
- Immunomodulatory treatment (including interferon) or LDT within 1 year prior to the first dose of treatment
- Patients included in another trial or having been given investigational drugs within 12 weeks prior to screening
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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 180ug/wk s.c for 48 weeks
Andra namn:
nucleos(t)ide analgoue (NA) 1 piece p.o for 48 weeks
|
Aktiv komparator: nucleos(t)ide analgoue
nucleos(t)ide analgoue (NA) 1 piece qd for 48 weeks
|
nucleos(t)ide analgoue (NA) 1 piece p.o for 48 weeks
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of participants who achieve HBeAg seroconversion
Tidsram: at week 48
|
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the HBeAg seroconversion in HBeAg positive CHB patients on treatment with Entecavir and with HBV DNA <1000copies/ml which will be measured by the number of participants who achieve HBeAg seroconversion
|
at week 48
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of participants who achieve HBeAg loss
Tidsram: at week 48
|
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve HBeAg seroconversion which will be measured by number of participants who achieve HBeAg loss
|
at week 48
|
Number of participants who achieve HBsAg loss
Tidsram: at week 48
|
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve HBsAg loss which will be measured by number of participants who achieve HBsAg loss
|
at week 48
|
Number of participants who achieve HBsAg seroconversion
Tidsram: at week 48
|
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve HBsAg seroconversion which will be measured by number of participants who achieve HBsAg seroconversion
|
at week 48
|
HBsAg decline from baseline
Tidsram: at week 48
|
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve HBsAg decline from baseline
|
at week 48
|
Percentage of participants who achieve HBsAg <1000IU/mL
Tidsram: at week 48
|
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the percentage of participants who achieve HBsAg<1000IU/mL
|
at week 48
|
Percentage of of participants who achieve HBsAg <100IU/mL
Tidsram: at week 48
|
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the percentage of of participants who achieve HBsAg<100IU/mL
|
at week 48
|
Number of participants who achieve combined response I (defined as HBeAg seroconversion and HBV DNA<100000copies/mL)
Tidsram: at week 48
|
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the combined response I which will be measured by number of participants who achieve combined response I
|
at week 48
|
Number of participants who achieve combined response II (defined as HBeAg seroconversion and HBV DNA<1000copies/mL)
Tidsram: at week 48
|
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the combined response II which will be measured by number of participants who achieve combined response II
|
at week 48
|
Number of participants who achieve dural response I (defined as HBeAg seroconversion and HBsAg<1000IU/mL)
Tidsram: at week 48
|
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the dural response I which will be measured by number of participants who achieve dural response I
|
at week 48
|
Number of participants who achieve dural response II (defined as HBeAg seroconversion and HBsAg<100IU/mL)
Tidsram: at week 48
|
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the dural response II which will be measured by number of participants who achieve dural response II
|
at week 48
|
Number of Participants with AE
Tidsram: at week 48
|
Number of participants with adverse events as a measure of safety and tolerability
|
at week 48
|
Number of Participants with SAE
Tidsram: at week 48
|
Number of participants with SAEs as a measure of safety and tolerability
|
at week 48
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Qing Xie, Ruijin Hospital
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Virussjukdomar
- Infektioner
- Blodburna infektioner
- Smittsamma sjukdomar
- Leversjukdomar
- Hepatit, Viral, Human
- Hepadnaviridae-infektioner
- DNA-virusinfektioner
- Hepatit, kronisk
- Hepatit
- Hepatit B
- Hepatit B, kronisk
- Anti-infektionsmedel
- Antivirala medel
- Peginterferon alfa-2a
Andra studie-ID-nummer
- HOPE
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Kronisk hepatit B
-
Clínica de Oftalmología de Cali S.AAvslutadMeibomisk körteldysfunktion | Eyes Dry ChronicColombia
-
AstraZenecaCLL ConsortiumAvslutadB-cellslymfom | 11q-deleted Relapsed/Refractory Chronic Lymfocytic Leukemi (KLL), | Prolymfocytisk leukemi (PLL)Förenta staterna
-
Alcon ResearchAvslutad
-
Jules Bordet InstituteMacopharma; Belgian Hematological SocietyRekryteringRefractory Chronic Graft Versus Host Disease (cGVHD)Belgien
-
Dhulikhel HospitalKathmandu University School of Medical SciencesIndragenPostoperativ analgesi | CSOM - Chronic Suppurative Otitis MediaNepal
-
Occyo GmbHUniversity Clinic for Ophthalmology and Optometry- SalzburgAvslutadLimbal stamcellsbrist | Hornhinnas sjukdom | Eyes Dry Chronic | Kronisk konjunktivit i båda ögonen | Ögonskada | Ögonsjukdom; Grå starr | Ögon torr känsla av | Hornhinnan inflammerad | Hornhinna; Skada, nötning | Hornhinna infektionÖsterrike
-
National Cancer Institute (NCI)Aktiv, inte rekryterandeÅterkommande diffust stort B-cellslymfom aktiverat B-cellstyp | Refraktärt diffust stort B-cellslymfom aktiverat B-cellstypFörenta staterna, Saudiarabien
-
Nathan DenlingerBristol-Myers SquibbRekryteringB-cells non-Hodgkin lymfom - återkommande | Diffust stort B-cellslymfom - återkommande | Follikulärt lymfom - återkommande | Höggradigt B-cellslymfom - återkommande | Primärt mediastinalt stort B-cellslymfom - återkommande | Transformerat indolent B-cells non-Hodgkin-lymfom till diffust stort... och andra villkorFörenta staterna
-
Northwestern UniversityNational Cancer Institute (NCI)Aktiv, inte rekryterandeDiffust stort B-cellslymfom | Diffust stort B-cellslymfom, ej specificerat på annat sätt | Höggradigt B-cellslymfom, ej specificerat på annat sätt | T-cell/Histiocyt-rik stort B-cellslymfom | Höggradigt B-cellslymfom med MYC och BCL2 och/eller BCL6 omarrangemang | Diffust stort B-cellslymfom aktiverat... och andra villkorFörenta staterna
-
Nanfang Hospital of Southern Medical UniversityRekryteringB-cellslymfom | B-cells akut lymfoblastisk leukemi | B-cellsleukemi | B-cellslymfom refraktär | B-cellslymfom ÅterkommandeKina
Kliniska prövningar på Peginterferon alfa-2a
-
Third Affiliated Hospital, Sun Yat-Sen UniversityPeking University; Huazhong University of Science and Technology; First People... och andra samarbetspartnersOkänd
-
Third Affiliated Hospital, Sun Yat-Sen UniversityPeking University; Huazhong University of Science and Technology; First People... och andra samarbetspartnersOkänd
-
Chugai PharmaceuticalAvslutad
-
Hoffmann-La RocheAvslutadHepatit B, kroniskRyska Federationen
-
Hoffmann-La RocheAvslutadHepatit B, kroniskTaiwan, Förenta staterna, Nya Zeeland, Singapore
-
Hoffmann-La RocheAvslutadHepatit B, kroniskKina, Hong Kong, Australien, Tyskland, Taiwan, Singapore, Frankrike, Förenta staterna, Korea, Republiken av, Nya Zeeland, Thailand, Ryska Federationen, Brasilien
-
Beijing Ditan HospitalOkänd
-
Third Affiliated Hospital, Sun Yat-Sen UniversityAvslutadAntiviral Treatment of Chronic Hepatitis B
-
M.D. Anderson Cancer CenterAvslutad
-
Hoffmann-La RocheAvslutad