Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Phase 2 Study of Yimitasvir Phosphate Capsules

16. března 2020 aktualizováno: Sunshine Lake Pharma Co., Ltd.

A Multicenter, Randomized, Parallel Assigned, Open-label Study to Investigate the Efficacy and Safety of Yimitasvir Phosphate (DAG181)/Sofosbuvir(SOF) Combination for 12 Weeks in Subjects With Chronic Genotype 1 HCV Infection

The safety, tolerability and antiviral activity of DAG181/SOF in treatment-naive and treatment-experienced patients with chronic hepatitis C virus (HCV) genotype 1 infection

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

A phase 2, multicenter, randomized, parallel Assigned, open-label study to explore the safety, tolerability and antiviral activity of DAG181/SOF combination for 12 weeks in adult subjects with chronic genotype 1 HCV infection.

Approximately 120 HCV genotype 1 subjects without cirrhosis will be enrolled, treatment-experienced subjects are ≤20%, all subjects will be randomized (1:1) to one of the following two treatment groups by IWRS (Medidata Balance): a) DAG181 100 mg/ SOF 400 mg once daily for 12 weeks, b) DAG181 200 mg/ SOF 400 mg once daily for 12 weeks. Randomization will be stratified by "treatment-naive" or "treatment-experienced".

Typ studie

Intervenční

Zápis (Aktuální)

129

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Čína
    • Beijing
      • Beijing, Beijing, Čína, 100034
        • Peking University First Hospital
      • Beijing, Beijing, Čína, 100069
        • Beijing youan hospital，capital medical university
      • Beijing, Beijing, Čína, 100044
        • Peking University People's Hospital
    • Gansu
      • Lanzhou, Gansu, Čína, 730000
        • The First Hospital of Lanzhou University
    • Guangdong
      • Guangzhou, Guangdong, Čína, 510515
        • Nanfang Hospital of Southern Medical University
      • Guangzhou, Guangdong, Čína, 510060
        • Guangzhou Eighth People's Hospital
    • Hainan
      • Haikou, Hainan, Čína, 570311
        • Hainan General Hospital
    • Hebei
      • Shijiazhuang, Hebei, Čína, 050051
        • The Third Hospital of Hebei Medical University
    • Hubei
      • Wuhan, Hubei, Čína, 430060
        • Renmin Hospital of Wuhan University
      • Wuhan, Hubei, Čína, 430022
        • Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
      • Wuhan, Hubei, Čína, 430030
        • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University Science & Technology
    • Hunan
      • Changsha, Hunan, Čína, 410008
        • Xiangyan Hospital, Central South University
    • Jiangsu
      • Nanjing, Jiangsu, Čína, 210003
        • The Second Hospital of Nanjing
    • Jiangxi
      • Nanchang, Jiangxi, Čína, 330006
        • The First Affiliated Hospital of Nanchang University
    • Jilin
      • Chang Chun, Jilin, Čína, 130021
        • The First Hospital of Jilin University
    • Shanxi
      • Xi'an, Shanxi, Čína, 710038
        • Tangdu Hospital
    • Sichuan
      • Chengdu, Sichuan, Čína, 610041
        • West China Hospital, Sichuan University

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  1. Willing and able to provide written informed consent;
  2. Male or female, age≥18 years;

  3. A female subject is eligible to enter the study if it is confirmed that she is:

    1. Of non-childbearing potential (i.e., women who have had a hysterectomy, have both ovaries removed or medically documented ovarian failure, or are postmenopausal-women > 50 years of age with cessation (for≥12 months) of previously occurring menses), or
    2. Of childbearing potential (Women≤50 years of age with amenorrhea will be considered to be of childbearing potential). These women must have a negative serum pregnancy test at screening, and must use specific contraceptive methods from screening until 4 weeks after last dose of study drugs, such as complete abstinence from intercourse, vaginal ring, cervical cap or contraceptive diaphragm, IUD, etc.
  4. All male study subjects must agree to consistently and correctly use specific contraceptive methods with their female partner from screening until 4 weeks after last dose of study drugs(except of surgical sterilization), such as complete abstinence from intercourse, condom, and their female partner use contraceptives , vaginal ring , cervical cap or contraceptive diaphragm, IUD, etc.
  5. Male subjects must agree to refrain from sperm donation from the date of screening until 4 weeks after the last dose of study drugs;
  6. Body mass index (BMI)≥18.0 and≤32.0 kg/m2, and Weight≥40 kg;

  7. Confirmation of chronic HCV infection documented by either:

    1. A positive anti-HCV antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Baseline/Day 1 visit, or
    2. A liver biopsy performed prior to the Baseline/Day 1 visit with evidence of chronic HCV infection.
  8. Serological detection of anti-HCV antibodies was positive at screening;
  9. HCV RNA≥1×104 IU/mL at Screening;
  10. HCV genotype 1a, 1b, or mixed 1a/1b at screening as determined by the Central Laboratory;

  11. Classification as treatment naive or treatment experienced:

    1. Treatment naive is defined as having never been exposed to approved or experimental HCV-specific direct-acting antiviral agents or prior treatment of HCV with interferon (with or without ribavirin);
    2. Treatment experienced is defined as prior treatment failure to a regimen containing interferon (IFN-α,β or Peg-IFN±RBV) that was completed at least 2 months prior to screening. and the subject's medical records must include sufficient detail of prior virologic failure to allow for categorization of prior response, as either:

    i) Non-Responder: Decrease of HCV RNA<2 log at week 12 compared to baseline; ii) Partially-Responder: Decrease of HCV RNA>2 log at week 12 compared to baseline, and detectable HCV RNA levels within week 12 and week 24; iii) Breakthrough/Relapse: Subject achieved undetectable HCV RNA levels (HCV RNA < LLOQ) during treatment, but did not achieve sustained virologic response (SVR); iv) Intolerance: Subjects have discontinued interferon-based treatment due to intolerance which proved by chief complaint or medical records.

  12. Absence of cirrhosis is defined as any one of the following:

    1. Liver biopsy within 2 years of Screening or at Screening showing absence of cirrhosis (e.g. Metavir score=0-3 or Ishak score<5), or
    2. Fibroscan within 6 months of Screening or at Screening with a result of ≤12.5 kPa.

    liver biopsy results will supersede fibroscan results and be considered definitive.

  13. Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.

Exclusion Criteria:

Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:

  1. Current or prior history of any of the following:

    1. Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage);
    2. Chronic liver disease of a non-HCV etiology (Including but not limited to hemochromatosis, Wilson's disease,alfa-1 antitrypsin deficiency);
    3. Significant cardiac disease(Including but not limited to myocardial infarction, bradycardia) ;
    4. Significant pulmonary disease;
    5. Malabsorption syndrome or gastrointestinal disorder or post operative condition that could interfere with the absorption of the study drug;
    6. Central nervous system trauma, epilepsy, stroke or transient ischemic attack;
    7. Psychiatric illness or psychological disease or relevant medical history;
    8. Malignancy diagnosed before signing the informed consent form ( except for specific cancers that have been cured by surgical resection (basal cell skin cancer, etc) or cervical carcinoma in situ are allowed). subjects under evaluation for malignancy are not eligible;
    9. Solid organ transplantation;
    10. Subjects have any other medical disorder that may interfere with subjects treatment, assessment or compliance with the protocol.

  2. Subjects has the following laboratory parameters at screening:

    1. ALT > 10×the upper limit of normal (ULN);
    2. AST > 10×ULN;
    3. Total bilirubin> 1.5 × ULN;
    4. Albumin< 3.5 g/dL;
    5. AFP>100 ng/mL; If 20 ng/mL≤AFP≤100 ng/mL, a liver ultrasound examination is required to exclude subjects suspected of hepatocellular carcinoma;
    6. INR > 1.5 x ULN;
    7. Hemoglobin<11 g/dL for female subjects; <12 g/dL for male subjects;
    8. Platelets<90 x109/L;
    9. Neutrophil absolute count< 1.5 ×109/L;
    10. HbA1c > 8.5%;
    11. Creatinine clearance (CLcr) <50 mL /min as calculated by the Cockcroft-Gault equation;
    12. HBsAg serology test results were positive;
    13. HIV antibody test results were positive.
  3. Screening ECG with clinically significant abnormalities;
  4. Prior exposure to approved or experimental HCV-specific direct-acting antiviral agent;
  5. Use of any prohibited concomitant medications;
  6. Significant drug allergy, or known hypersensitivity to DAG181, SOF and its metabolites, or formulation recipients;
  7. A positive drug screen at screening will exclude subjects unless it can be explained by non-prescription drug or prescribed medication; the diagnosis and prescription must be approved by the investigator;
  8. Pregnant or nursing female or male with pregnant female partner.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: SOF+DAG181 100 mg
Patients with genotype 1 HCV infection without cirrhosis will receive SOF+DAG181 100 mg for 12 weeks.
Lék: SOF
400 mg tableta podávaná perorálně jednou denně
Ostatní jména:
  • sofosbuvir
  • Sovaldi®
Lék: DAG181
Capsule administered orally once daily
Ostatní jména:
  • Yimitasvir
Experimentální: SOF+DAG181 200 mg
Patients with genotype 1 HCV infection without cirrhosis will receive SOF+DAG181 200 mg for 12 weeks.
Lék: SOF
400 mg tableta podávaná perorálně jednou denně
Ostatní jména:
  • sofosbuvir
  • Sovaldi®
Lék: DAG181
Capsule administered orally once daily
Ostatní jména:
  • Yimitasvir

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of subjects with sustained virologic response 12 weeks after discontinuation of therapy (SVR12)
Časové okno: Posttreatment Week 12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment
Posttreatment Week 12
Safety and tolerability were evaluated based on adverse event monitoring, laboratory tests, 12-lead ECG assessments, vital signs measurements and physical examinations.
Časové okno: Up to posttreatment week 24
Up to posttreatment week 24

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of subjects with sustained virologic response 4, 8 and 24 weeks after discontinuation of therapy (SVR4,SVR8 and SVR24)
Časové okno: Posttreatment Weeks 4,8 and 24
SVR4,SVR8 and SVR24 were defined as HCV RNA < the lower limit of quantitation (LLOQ) at 4, 8 and 24 weeks after stopping study treatment, respectively.
Posttreatment Weeks 4,8 and 24
Percentage of subjects with HCV RNA < the lower limit of quantitation (LLOQ) while on treatment
Časové okno: Baseline to week 12
Baseline to week 12
The time to first achieve "HCV RNA < the lower limit of quantitation (LLOQ)" while on treatment
Časové okno: Baseline to week 12
Baseline to week 12
HCV RNA change from baseline
Časové okno: Up to posttreatment week 24
Up to posttreatment week 24
Percentage of subjects with virologic failure
Časové okno: Up to posttreatment week 24

Virologic failure was defined as:

  1. On-treatment virologic failure: Breakthrough (confirmed HCV RNA ≥the lower limit of quantitation (LLOQ) after having previously had HCV RNA <the lower limit of quantitation (LLOQ) while on treatment), or Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Non-response (HCV RNA persistently ≥the lower limit of quantitation (LLOQ) through 8 weeks of treatment);
  2. Virologic relapse: Confirmed HCV RNA ≥the lower limit of quantitation (LLOQ) during the posttreatment period having achieved HCV RNA <the lower limit of quantitation (LLOQ) at last on-treatment visit.
Up to posttreatment week 24
Viral resistance
Časové okno: Up to posttreatment week 24
Viral resistance to DAG181 and/or SOF during treatment and after cessation of treatment
Up to posttreatment week 24

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Sunshine Lake Pharma Co., Ltd.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

31. července 2017

Primární dokončení (Aktuální)

8. května 2018

Dokončení studie (Aktuální)

26. září 2018

Termíny zápisu do studia

První předloženo

10. února 2018

První předloženo, které splnilo kritéria kontroly kvality

1. března 2018

První zveřejněno (Aktuální)

8. března 2018

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

18. března 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

16. března 2020

Naposledy ověřeno

1. března 2020

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • PCD-DDAG181PA-16-005

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Chronická infekce HCV

Klinické studie na SOF

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Turkmenistan

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

Předplatit