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Safety and Antiviral Activity Study of Clevudine 30 mg QD in Patients With HBeAg(-) Chronic HBV

30. januar 2017 opdateret af: Bukwang Pharmaceutical

A Double-Blind, Randomized, Parallel, Placebo-Controlled Phase III Study to Evaluate the Safety and Antiviral Activity of Clevudine (L-FMAU) 30 mg QD in Patients With HBeAg Negative Chronic Hepatitis B

The purpose of this study is to determine safety and efficacy of 30mg daily dose of clevudine (L-FMAU) at 24 weeks of treatment in chronic HBV infected patients with HBeAg negative

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding

80

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Korea, Republikken
    • Bupyoung-gu, Incheon
      • Bupyoung-dong, Bupyoung-gu, Incheon, Korea, Republikken
        • St. Mercy's Hospital
    • Chongro-gu, Seoul
      • Pyoung-dong, Chongro-gu, Seoul, Korea, Republikken
        • Kangbuk Samsung Hospital
    • Daegu
      • Jung-gu, Daegu, Korea, Republikken
        • Keimyumg University Dongsan Medical Center
    • Dong-gu, Gwangju-si
      • Hak-1-dong, Dong-gu, Gwangju-si, Korea, Republikken
        • Chonnam National University Hospital
    • Guro-gu
      • Seoul City, Guro-gu, Korea, Republikken
        • Korea University Guro Hospital
    • Jeonbuk
      • Iksan-City, Jeonbuk, Korea, Republikken
        • Wonkwang University Hospital
      • Jeonju-city, Jeonbuk, Korea, Republikken
        • Chonbuk National University Hospital
    • Jongno-Gu
      • Seoul, Jongno-Gu, Korea, Republikken
        • Seoul National University Hospital
    • Jung-gu, Incheon
      • Sinhung-dong, Jung-gu, Incheon, Korea, Republikken
        • Inha University Hospital
    • Kangnam-gu, Seoul
      • Dogok-dong, Kangnam-gu, Seoul, Korea, Republikken
        • Yongdong Severance Hospital
      • Pungnap-dong, Kangnam-gu, Seoul, Korea, Republikken
        • Seoul ASAN Medical Center
    • Kyounggi-do
      • Ilsan-gu, Kyounggi-do, Korea, Republikken
        • National Cancer Center
      • Puch'onae, Kyounggi-do, Korea, Republikken
        • St. Holly Family Mary's Hospital
      • Seongnam-gu, Kyounggi-do, Korea, Republikken
        • Pochon CHA University Hospital
    • Nam-gu, Taegu
      • Dae myoung-dong, Nam-gu, Taegu, Korea, Republikken
        • Yeungnam University Medical Center
    • Namdong-Gu
      • Incheon, Namdong-Gu, Korea, Republikken
        • Gil Medical Center
    • Nowon-gu, Seoul
      • Hagye 1-dong, Nowon-gu, Seoul, Korea, Republikken
        • Nowon Eulji Hospital
    • Paldal-gu, Suwon
      • Ji-dong, Paldal-gu, Suwon, Korea, Republikken
        • St. Vincent's Hospital
    • Pusan
      • Gaegeum-dong, Pusan, Korea, Republikken
        • Pusan Paik Hospital
    • Seo-gu, Pusan
      • Ami-dong, Seo-gu, Pusan, Korea, Republikken
        • Pusan National University Hospital
      • Amnam-dong, Seo-gu, Pusan, Korea, Republikken
        • Kosin Medical Center
    • Seocho-gu, Seoul
      • Banpo-dong, Seocho-gu, Seoul, Korea, Republikken
        • KangNam St. Mary's Hospital
    • Seodaemun-gu, Seoul
      • Shinchon- dong, Seodaemun-gu, Seoul, Korea, Republikken
        • Severance Hospital
    • Seoul
      • Jeo-dong, Seoul, Korea, Republikken
        • Seoul Paik Hospital
    • Songpa-gu, Seoul
      • Ilwon-dong, Songpa-gu, Seoul, Korea, Republikken
        • Samsung Medical Center
    • Sungbuk-ku, Seoul
      • Anam-dong, Sungbuk-ku, Seoul, Korea, Republikken
        • Korea University Anam Hospital
    • Yangcheon-gu, Seoul
      • Mokdong, Yangcheon-gu, Seoul, Korea, Republikken
        • Ehwa Womans University Mokdong Hospital
    • Yongdeungpo-gu, Seoul
      • Daelim-dong, Yongdeungpo-gu, Seoul, Korea, Republikken
        • KangNam Sacred Heart Hospital
    • Yongsan-gu, Seoul
      • Hannam-dong, Yongsan-gu, Seoul, Korea, Republikken
        • Soon Chun Hyang University Hospital
    • Yungdungpo-Gu
      • Seoul, Yungdungpo-Gu, Korea, Republikken
        • St. Mary's Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Patients who were between 18 and 60, inclusive
  2. Patients with HBV DNA levels 1 x 105 copies/mL within 30 days of baseline.
  3. Patients who were documented to be HBsAg positive for > 6 months (documentation of positive HBsAg for the previous 6 months included previous laboratory reports showing HBsAg positive at least 6 month ago OR lab results showing IgM anti-HBc negative and IgG anti-HBc positive at screening).
  4. Patients who were HBeAg negative and HBeAb positive.
  5. Patients with ALT levels which were in the range of ≥1.2 and < 15 times the upper limit of normal (ULN) and bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), a serum albumin level of at least 3.5 g/dL.
  6. Women of childbearing potential with a negative serum (β-HCG) pregnancy test taken within 14 days of starting therapy.
  7. Patients who were able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

  1. Patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy.
  2. Patients previously treated with lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for HBV infection. Previous treatment with interferon that had ended less than 6 months prior to the screening visit.
  3. Patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy.
  4. Patients coinfected with HCV, HDV or HIV.
  5. Patients with clinical evidence of liver mass or with alfa-fetoprotein > 50 ng/mL
  6. Patients who were pregnant or breast-feeding.
  7. Patients who were unwilling to use an "effective" method of contraception during the treatment period and for up to 3 months after cessation of therapy. For males, condoms should be used. Females had to be surgically sterile (via hysterectomy or bilateral tubal ligation) or post-menopausal or using at least medically acceptable barrier method of contraception (i.e. IUD, barrier methods with spermicide or abstinence)
  8. Patients with a clinically relevant history of abuse of alcohol or drugs.
  9. Patients with a significant gastrointestinal, renal, hepatic (decompensated), broncho-pulmonary, biliary diseases except asymptomatic GB stone, neurological, cardiovascular, oncologic or allergic disease. The patient with a benign tumor was excluded if judged by an investigator that the continuation of study would be interfered by benign tumor.
  10. Patients with creatinine clearance less than 60mL/min as estimated by the following formula:

(140-age in years) (body weight [kg])/(72) (serum creatinine [mg/dL]) [Note: multiply estimates by 0.85 for women]

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Uønskede hændelser
Vitale tegn
Laboratorieundersøgelser
Effektivitet:
Sikkerhed:
EKG
Antiviral activity (change from baseline in HBV DNA (log 10))

Sekundære resultatmål

Resultatmål
Effektivitet
Antiviral activity: proportion of patients with HBV DNA below the assay limit of detection (<4,700 copies/mL by Digene Hybrid Capture II assay)
Biochemical improvement (e.g. ALT normalization )

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bukwang Pharmaceutical

Efterforskere

  • Ledende efterforsker: Hyo-Suk Lee, MD. PhD, Seoul National University Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2003

Studieafslutning

1. december 2004

Datoer for studieregistrering

Først indsendt

11. april 2006

Først indsendt, der opfyldte QC-kriterier

11. april 2006

Først opslået (Skøn)

12. april 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. februar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. januar 2017

Sidst verificeret

1. april 2006

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • L-FMAU-302

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hepatitis B

Kliniske forsøg med Clevudine

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