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- Klinische proef NCT01464281
A Study of Switch From Nucleotide to Peginterferon Alfa-2a in CHB Patients Achieving HBeAg Loss and HBV DNA <200IU/ml (New Switch)
A Randomized, Multicenter Study Evaluating HBsAg Clearance in CHB Patients Achieving HBeAg Loss and HBV DNA <200copies/ml on Treatment With Nucleotide Analogues and Switched to Peginterferon Alfa-2a
A Randomized, open-label, multicenter study.
The patients after 1-3 years NAs treatment and having achieved HBeAg loss and HBV DNA <200IU/ml will be switched to Pegasys for 48 or 96 weeks (with a 12 weeks period of overlap with the NA for safety reasons). The subjects will be randomized into 2 groups:
Group 1 : 48-week standard treatment by Peginterferon alfa 2a 180µg/week Group 2 : 96-week prolonged treatment by Peginterferon alfa 2a 180µg/week.
All the patients will be followed up for 48 weeks after discontinuation of the study medication.
Note: NAs will be stratified LAM, ETV and ADV, with the ratio 1:1:1.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Chongqing
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Chongqing, Chongqing, China, 400010
- The 2nd affiliated Hospital of Chongqing Medical University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Patients on-treatment with NAs (ADV, ETV or LAM) for 1-3 years, having achieved HBeAg loss at screening, and HBV DNA <200IU/ml for at least 48 weeks
- Male and female patients ≥ 18 to 65 years of age
- Chronic hepatitis B (positive HBsAg for at least 6 months prior to NA therapy start)
- Compensated liver disease (Child-Pugh <6)
- Absence of hepatocellular carcinoma on liver imaging and/or alfa fetoprotein < 50 ng/ml
- Negative urine or blood pregnancy test for women of childbearing potential within 24 hours of first PEG IFN study medication administration
- Able and willing to provide informed consent and abide by the requirements of the study
Exclusion Criteria:
- Neutrophil count <1.5 x 109cells/L or platelet count <90 x 109cells/L
- Co-infections with HIV, HAV, HCV, HDV or HEV
- Women with ongoing pregnancy or breast feeding, or wishing to become pregnant during the study period
- Prolonged and excessive alcohol intake (> 40g/day for men and > 30g/day for women)
- Active intravenous drug abuse
- History or current treatment with telbivudine
- Treatment with immunomodulators (e.g. Interferon) for less than one year before study enrollment
- Treatment with immunosuppressors (including systemic corticosteroids) or anti-neoplastic treatment (including radiation therapy) <=6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
- Serum concentrations of ceruloplasmin or alfa-antitrypsin consistent with an increased risk of metabolic disease
- History or other evidence of chronic pulmonary disease associated with functional limitation
- History of severe cardiac disease
- History of the severe seizure disorder or current anticonvulsivant use
- History of thyroid disease poorly controlled on prescribed medications. Patients with elevated thyroid stimulating hormone concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
- History or other evidence of severe retinopathy
- History of autoimmune disease or presence of a significant level of auto-antibodies
- Renal insufficiency (creatinine clearance of < 50 ml/min according to the Cockroft and Gault equation), kidney transplant, hemodialysis
- History of depression or uncontrolled psychiatric disorders
- Subjects protected by law or not in a position to give consent
- Patients with reproductive potential not willing to use an effective method of contraception.
- Evidence of an active or suspected cancer or a history of malignancy (other than basocellular carcinoma or in-situ cervical carcinoma)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 48-week standard treatment
48-week standard treatment by Peginterferon alfa 2a 180µg/week
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Group 1 : 48-week standard treatment by Peginterferon alfa 2a 180µg/week Group 2 : 96-week prolonged treatment by Peginterferon alfa 2a 180µg/week.
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Actieve vergelijker: 96-week prolonged treatment
96-week prolonged treatment by Peginterferon alfa 2a 180µg/week
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Group 1 : 48-week standard treatment by Peginterferon alfa 2a 180µg/week Group 2 : 96-week prolonged treatment by Peginterferon alfa 2a 180µg/week.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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determine the response rate (HBsAg clearance at Week 48 and 96)
Tijdsspanne: 1 year
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To determine the response rate (HBsAg clearance at Week 48 and 96) in subjects who are being treated by NAs and achieved a combined response which consists of both HBeAg loss and HBV DNA <1000 copies/ml
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1 year
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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HBsAg/HBeAg/HBV DNA changes/ALT normalization /HBsAg seroconversion at EOT and EOF
Tijdsspanne: 1 year
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1 year
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Hong Ren, The 2nd affiliated Hospital of Chongqing Medical University
Publicaties en nuttige links
Algemene publicaties
- Hu P, Shang J, Zhang WH, Gong GZ, Li YG, Chen XY, Jiang JN, Xie Q, Dou XG, Sun YT, Li YF, Liu YX, Liu GZ, Ma DW, Chi XL, Tang H, Li XO, Xie Y, Chen XP, Jiang JJ, Zha P, Hou JL, Gao ZL, Fan HM, Ding JG, Zhang DZ, Ren H. [HBsAg loss with Pegylated-interferon alfa-2a in hepatitis B patients with partial response to nucleos(t)-ide analog: new switch study]. Zhonghua Gan Zang Bing Za Zhi. 2018 Oct 20;26(10):756-764. doi: 10.3760/cma.j.issn.1007-3418.2018.10.005. Chinese.
- Hu P, Shang J, Zhang W, Gong G, Li Y, Chen X, Jiang J, Xie Q, Dou X, Sun Y, Li Y, Liu Y, Liu G, Mao D, Chi X, Tang H, Li X, Xie Y, Chen X, Jiang J, Zhao P, Hou J, Gao Z, Fan H, Ding J, Zhang D, Ren H. HBsAg Loss with Peg-interferon Alfa-2a in Hepatitis B Patients with Partial Response to Nucleos(t)ide Analog: New Switch Study. J Clin Transl Hepatol. 2018 Mar 28;6(1):25-34. doi: 10.14218/JCTH.2017.00072. Epub 2018 Mar 17.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Virusziekten
- Infecties
- Door bloed overgedragen infecties
- Overdraagbare ziekten
- Lever Ziekten
- Hepatitis, viraal, menselijk
- Hepadnaviridae-infecties
- DNA-virusinfecties
- Hepatitis, chronisch
- Hepatitis
- Hepatitis B
- Hepatitis B, chronisch
- Anti-infectieuze middelen
- Antivirale middelen
- Peginterferon alfa-2a
Andere studie-ID-nummers
- ML27928
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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