Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Safety and Antiviral Activity of Clevudine in Patients Who Have Completed the L-FMAU-301 or L-FMAU-302 Trials

30. januar 2017 opdateret af: Bukwang Pharmaceutical

An Open-label, Phase III Clinical Trial to Evaluate the Safety and Antiviral Activity of Clevudine in Chronic Hepatitis B Patients Who Have Completed the L-FMAU-301 or L-FMAU-302 Trials

The purpose of this study is to determine safety and efficacy of clevudine 10 mg qd for 24 weeks after completion of 24-week treatment with clevudine 30 mg qd with 12 weeks follow-up period

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Patient is between 18 and 60, inclusive
  2. Patients who have completed L-FMAU-301 or L-FMAU-302 clinical trial.
  3. Patient is HBsAg positive at week 48 in L-FMAU-301 or L-FMAU-302.
  4. Patient has 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 at week 48 in L-FMAU-301 or L-FMAU-302.
  5. Women of childbearing potential must have a negative serum (β-HCG) pregnancy test at screening.
  6. Patient is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

  1. Patients with HBV DNA < 4,700 copies/mL, ALT normalization and consecutive e seroconversion at week 40 and 48 in L-FMAU-301
  2. Patients with HBV DNA < 4,700 copies/mL and ALT normalization in L-FMAU-302
  3. Patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
  4. Patients previously treated with α-interferon, lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection.
  5. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
  6. Patient is coinfected with HCV, HDV or HIV.
  7. Patient with clinical evidence of liver mass or hepatocellular carcinoma and α-Fetoprotein > 50 ng/mL
  8. Patient is pregnant or breast-feeding.
  9. Patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases. For males, condoms should be used. Females must 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)
  10. Patient has a clinically relevant history of abuse of alcohol or drugs.
  11. Patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, biliary diseases excluding asymptomic GB stone, neurological, cardiovascular, oncologic or allergic disease. The patient with a benign tumor except for liver mass, excluded if judged by an investigator that the continuation of study would be interfered by the tumor.
  12. Patient has 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]

13.Patient whom investigator consider is not suitable in this study

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: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Efficacy:change from baseline in HBV DNA; Safety: clinically measured adverse events, abnormality of laboratory tests and abnormality of vital signs, ECG.

Sekundære resultatmål

Resultatmål
Efficacy:; Proportion of patients with HBV DNA below the assay Limit of Detection; Proportion of patients with HBeAg loss and/or seroconversion (HBeAg loss and HBeAb gain); Proportion of 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

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. juni 2004

Studieafslutning

1. marts 2006

Datoer for studieregistrering

Først indsendt

8. august 2006

Først indsendt, der opfyldte QC-kriterier

8. august 2006

Først opslået (Skøn)

10. august 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. februar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. januar 2017

Sidst verificeret

1. juni 2006

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • L-FMAU-303

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

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Tanzania

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner