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Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis B Patients Based on the Roadmap Concept

6. mars 2018 oppdatert av: Novartis Pharmaceuticals

OPTIMA: A Randomized, Open-label, 156-week Treatment Study to Evaluate the Efficacy and Safety of Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis B Patients Based on the Roadmap Concept

The purpose of this study is to evaluate the efficacy and safety following the Roadmap Concept strategy with an initial monotherapy using either telbivudine or tenofovir in HBeAg negative CHB patients. The data from the study should allow for the validation of the Roadmap concept in a prospective manner, for both telbivudine and tenofovir treated HBeAg negative CHB patients. As part of a post-approval commitment to the European Health Authorities, the data will also be used to provide an optimized clinical treatment strategy for better clinical use of telbivudine in European HBeAg negative patients. Furthermore, the data from the study will contribute to a better scientific understanding, disease management and treatment of HBeAg negative CHB patients.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

241

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Bulgaria
      • Sofia, Bulgaria, 1527
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1413
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1431
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1407
        • Novartis Investigative Site
      • Varna, Bulgaria, 9010
        • Novartis Investigative Site
  • Den russiske føderasjonen
      • Moscow, Den russiske føderasjonen
        • Novartis Investigative Site
      • Moscow, Den russiske føderasjonen, 111123
        • Novartis Investigative Site
      • Moscow, Den russiske føderasjonen, 119333
        • Novartis Investigative Site
      • Moscow, Den russiske føderasjonen, 119992
        • Novartis Investigative Site
      • Moscow, Den russiske føderasjonen, 127473
        • Novartis Investigative Site
      • Moscow, Den russiske føderasjonen, 129110
        • Novartis Investigative Site
      • Saint-Petersburg, Den russiske føderasjonen, 194044
        • Novartis Investigative Site
  • Hellas
      • Athens, Hellas, 115 27
        • Novartis Investigative Site
    • Evros
      • Alexandroupolis, Evros, Hellas, 681 00
        • Novartis Investigative Site
    • GR
      • Athens, GR, Hellas, 115 21
        • Novartis Investigative Site
      • Thessaloniki, GR, Hellas, 546 42
        • Novartis Investigative Site
  • Italia
    • CE
      • Caserta, CE, Italia, 81100
        • Novartis Investigative Site
  • Spania
    • Catalunya
      • Barcelona, Catalunya, Spania, 08035
        • Novartis Investigative Site
      • Barcelona, Catalunya, Spania, 08003
        • Novartis Investigative Site
    • Cataluña
      • Tarragona, Cataluña, Spania, 43005
        • Novartis Investigative Site
    • Madrid
      • Majadahonda, Madrid, Spania, 28222
        • Novartis Investigative Site
  • Tyrkia
      • Diyarbakir, Tyrkia, 21280
        • Novartis Investigative Site
      • Izmir, Tyrkia, 35040
        • Novartis Investigative Site
      • Trabzon, Tyrkia, 61080
        • Novartis Investigative Site
    • TUR
      • Istanbul, TUR, Tyrkia, 34098
        • Novartis Investigative Site
  • Tyskland
      • Frankfurt, Tyskland, 60590
        • Novartis Investigative Site
      • Freiburg, Tyskland, 79106
        • Novartis Investigative Site
      • Hamburg, Tyskland, 20099
        • Novartis Investigative Site
      • Hannover, Tyskland, 30625
        • Novartis Investigative Site
      • Herne, Tyskland, 44623
        • Novartis Investigative Site
      • Leipzig, Tyskland, 04103
        • Novartis Investigative Site
      • Wurzburg, Tyskland, 97080
        • Novartis Investigative Site
  • Østerrike
      • Innsbruck, Østerrike, A-6020
        • Novartis Investigative Site
      • Wien, Østerrike, 1090
        • Novartis Investigative Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

Male or female, at least 18 years of age

Documented compensated HBeAg negative CHB defined by all of the following:

  • Detectable serum HBsAg at screening visit and at least 6 months prior;
  • HBeAg negative at the screening visit with positive HBeAb;
  • Serum HBV DNA > 2000 IU/mL Serum ALT level > 1×ULN and <10×ULN at screening visit; patient with normal ALT ≤1xULN at screening are eligible, with moderate liver inflammation or fibrosis, complensated liver sirrhosis, ALT level >1xULN wtihin last 6 months

Exclusion Criteria:

  • Co-infected with HCV, HDV or HIV.
  • Received treatment of nucleoside or nucleotide drugs at any time
  • Received IFN or other immunomodulatory treatment within six months before Screening
  • Pregnant or nursing (lactating) women
  • Clinical signs/symptoms of hepatic decompensation
  • History of myopathy, myositis or persistent muscle weakness
  • history of clinical and laboratory evidence of chronic renal insufficency

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: telbivudine
telbivudine 600 mg tablet orally (p.o.) once daily for up to 156 weeks. Patients with HBV DNA ≥ 300 copies/mL at Week 24 were to initiate add-on therapy with tenofovir 300 mg tablets p.o. once daily for the remaining weeks of treatment. The investigator was to initiate tenofovir add-on therapy within 2 weeks of central laboratory confirmation. Patients with HBV DNA < 300 copies/mL at Week 24 were to continue to receive telbivudine monotherapy
Legemiddel: telbivudine
600 mg film-coated tablets taken as 600 mg once daily
Andre navn:
  • LDT600
Aktiv komparator: tenofovir
tenofovir 300 mg tablets p.o. once daily for up to 156 weeks. Patients with HBV DNA ≥ 300 copies/mL at Week 24 were to initiate add-on therapy with telbivudine 600 mg tablet p.o. once daily for the remaining weeks of treatment. The investigator was to initiate telbivudine add-on therapy within 2 weeks of central laboratory confirmation. Patients with HBV DNA < 300 copies/mL at Week 24 were to continue to receive tenofovir monotherapy
Legemiddel: tenofovir disoproxil fumarate
300 mg tablets taken as 300 mg once daily

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants Achieving HBV DNA < 300 Copies/mL (51 IU/mL) at Week 52 (rITT Population) -
Tidsramme: week 52
The primary objective of the study is to compare the efficacy of Roadmap-Concept-based telbivudine treatment versus Roadmap-Concept-based tenofovir treatment in HBeAg-negative CHB patients. The rate of HBV DNA < 300 copies/mL (51 IU/mL) at week 52 will be used for the comparison of the efficacy. The hypothesis is that the aggregated rate of HBV DNA < 300 copies/mL (51 IU/mL) at week 52 of Telbivudine (ARM 1) is non-inferior to Tenofovir (ARM 2). For the "treating missing as failure" analysis, patients who came for their primary endpoint Week 52 visit within the ± 7-day window but not on the exact designated day of the visit were treated as "missing data."
week 52

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Patients Achieving Secondary Efficacy Endpoints (rITT)
Tidsramme: week 24, 52, 104
To assess the antiviral efficacy, as evaluated by the percentage of patients achieving HBV DNA <300 copies/mL (51 IU/mL), ALT normalization, HBsAg loss, HBsAg conversion, virologic breakthrough (VB) at study visit, cumulative VB by study defined study period, cumulative treatment-emergent resistance
week 24, 52, 104
Percentage of Participants Achieving Secondary Efficacy Endpoints at Week 156 (mITT)
Tidsramme: 156 weeks
To assess the antiviral efficacy, as evaluated by the percentage of patients achieving HBV DNA <300 copies/mL (51 IU/mL) at Week156, ALT normalization, HBsAg loss, development of HBsAg conversion , cumulative tx emergent resistance, HBV DNA <300 copies/mL with HBV DNA <7 log at Baseline
156 weeks
eGFR Change From Baseline in Telbivudine Arm vs Tenofovir Arm Over the Course of the Study
Tidsramme: Baseline, 24 weeks, 52 weeks, 104 weeks, 156 weeks
eGFR changes were calculated using the Modification of Diet in Renal Disease (MDRD) formula: GFR = 186 x (sCr)^(-1.154) x (age)^-0.203 with Female: Multiply GFR by 0.742; Black: Multiply GFR by 1.210. sCr is Serum Creatinine in mg/dl (measured at each scheduled visit). Age in years at visit (=[sCr sample collection date -Date of birth]/365.25). Weight in kilograms, as measured at the visit or the closest previous visit Safety population.
Baseline, 24 weeks, 52 weeks, 104 weeks, 156 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Novartis Pharmaceuticals

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

21. mars 2011

Primær fullføring (Faktiske)

10. desember 2015

Studiet fullført (Faktiske)

10. desember 2015

Datoer for studieregistrering

Først innsendt

21. juni 2011

Først innsendt som oppfylte QC-kriteriene

22. juni 2011

Først lagt ut (Anslag)

23. juni 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. november 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. mars 2018

Sist bekreftet

1. mars 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CLDT600A2409
  • 2007-000180-13 (Registeridentifikator: Eudract)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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