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Safety and Antiviral Activity of Clevudine in Patients Infected With Hepatitis B Virus

11. april 2006 opdateret af: Bukwang Pharmaceutical

A Double- Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiviral Activity of Clevudine 30 Mg QD and 50 Mg QD Doses in Patients Infected With Hepatitis B Virus

The purpose of this study is to determine the antiviral effects and safety of clevudine 30 mg once a day (QD) and 50 mg QD in patients infected with hepatitis B virus (HBV).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding

120

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Korea, Republikken
    • Guro-ku, Seoul
      • Guro-dong, Guro-ku, Seoul, Korea, Republikken, 152-703
        • Korea University Guro Hospital
    • Jongno-Gu, Seoul
      • Yeongeon-dong, Jongno-Gu, Seoul, Korea, Republikken, 110-744
        • Seoul National University
    • Kangdong-Gu, Seoul
      • Gil-dong, Kangdong-Gu, Seoul, Korea, Republikken, 134-701
        • Kangdong Sacred Heart Hospital
    • Kangnam-Gu, Seoul
      • Dogok-dong, Kangnam-Gu, Seoul, Korea, Republikken, 146-92
        • Yongdong Severance Hospital
      • Ilwon-dong, Kangnam-Gu, Seoul, Korea, Republikken, 135-710
        • Samsung Medical Center
    • Songpa-Gu, Seoul
      • Pungnab2-dong, Songpa-Gu, Seoul, Korea, Republikken, 388-1
        • Asan Medical Center
    • Yangchon-Gu, Seoul
      • Mok-dong, Yangchon-Gu, Seoul, Korea, Republikken, 911-1
        • Ewha Womans University Hospital
    • Yougdungpo-Gu, Seoul
      • Youido, Yougdungpo-Gu, Seoul, Korea, Republikken, 150-713
        • 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. Patient who is between 18 and 60 years of age, inclusive
  2. Patient who is HBV DNA positive with DNA levels at screening more than 3 x 10^6 copies/mL.

  3. Patient who is documented to be hepatitis B surface antigen (HBsAg) positive for > 6 months. Patient is HBeAg positive and anti-HBe negative.

    Evidence of HBsAg (+) for the previous 6 months may include the following:

    • documentation of HBsAg (+) for the previous 6 months
    • documentation of HBsAg (+) for the previous 3 months and IgM anti-HBc negative at screening
    • IgM anti-HBc negative and IgG anti-HBc positive at screening
  4. Patient who has ALT levels which are in the range of more than 2 to less than 10 times the upper limit of normal (x ULN) and bilirubin levels < 1.5 x ULN.
  5. Female patient with a negative serum (HCG) pregnancy test taken within 14 days of starting therapy.
  6. Patient who is able to give written informed consent prior to study start and to comply with the study requirements.

  7. Patients who continue to meet the following criteria after completion of the Week 36 visit will have additional follow-up visits at Week 40, 44, 48:

    • have received no additional therapy since completion of 12 weeks of treatment of L-FMAU and
    • continue with period 1 log10 decrease in HBV DNA from baseline.

Exclusion Criteria:

  1. Patient who is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
  2. Patients previously treated with lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection.
  3. Patients with previous treatment with interferon that have ended less than 6 months prior to the screening visit.
  4. Patient who has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
  5. Patient who is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV.
  6. Patient with clinical evidence of cirrhosis or hepatocellular carcinoma
  7. Patient who is pregnant or breast-feeding.
  8. Patient who is unwilling to use an "effective" method of contraception during the study and for up to 30 days after the use of study drug ceases. For males, condoms should be used. Females must be surgically sterile (via hysterectomy or bilateral tubal ligation), post-menopausal or using at least a medically acceptable barrier method of contraception (i.e., intrauterine device [IUD], barrier methods with spermicide or abstinence)
  9. Patient who has a clinically relevant history of abuse of alcohol or drugs.
  10. Patient who has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease.
  11. Patient who has creatinine clearance less than 60 mL/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]

Patients found to have tyrosine, methionine, aspartate, aspartate (YMDD) HBV DNA polymerase mutation after the enrollment will be excluded from the efficacy evaluation but included in the safety evaluation.

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
Effektivitet: Ændring fra baseline i HBV DNA (log10)

Sekundære resultatmål

Resultatmål
Sikkerhed
Vitale tegn
Uønskede hændelser
Laboratorieundersøgelser
Efficacy: Proportion of patients with HBV DNA below 1 pg/mL
Proportion of patients with HBV DNA below the assay limit of detection (LOD) (SuperDigene HC test II LOD, <4,700 copies/mL)
Proportion of patients with hepatitis Be antigen (HBeAg) loss
Seroconversion rate (HBeAg loss and hepatitis Be antibody [HBeAb] positivity)
Biochemical improvement (e.g., ALT normalization)
Electrocardiogram (ECG)

Samarbejdspartnere og efterforskere

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

Sponsor

Bukwang Pharmaceutical

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 2002

Studieafslutning

1. marts 2004

Datoer for studieregistrering

Først indsendt

17. marts 2006

Først indsendt, der opfyldte QC-kriterier

19. marts 2006

Først opslået (Skøn)

21. marts 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. april 2006

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. april 2006

Sidst verificeret

1. april 2006

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • L-FMAU-201

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 .

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