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Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 2)

18 sierpnia 2015 zaktualizowane przez: Boehringer Ingelheim

A Phase III, Randomized, Double Blind and Placebo Controlled Study of Once Daily BI 201335 120 mg for 24 Weeks and BI 201335 240 mg for 12 Weeks in Combination With Pegylated Interferon Alpha and Ribavirin in Treatment Naive Patients With Genotype 1 Chronic Hepatitis C Infection.

The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

658

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada
        • 1220.47.1011 Boehringer Ingelheim Investigational Site
      • Edmonton, Alberta, Kanada
        • 1220.47.1012 Boehringer Ingelheim Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Kanada
        • 1220.47.1001 Boehringer Ingelheim Investigational Site
      • Vancouver, British Columbia, Kanada
        • 1220.47.1003 Boehringer Ingelheim Investigational Site
      • Vancouver, British Columbia, Kanada
        • 1220.47.1016 Boehringer Ingelheim Investigational Site
      • Victoria, British Columbia, Kanada
        • 1220.47.1007 Boehringer Ingelheim Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Kanada
        • 1220.47.1009 Boehringer Ingelheim Investigational Site
    • Ontario
      • Hamilton, Ontario, Kanada
        • 1220.47.1013 Boehringer Ingelheim Investigational Site
      • London, Ontario, Kanada
        • 1220.47.1002 Boehringer Ingelheim Investigational Site
      • Ottawa, Ontario, Kanada
        • 1220.47.1004 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Kanada
        • 1220.47.1005 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Kanada
        • 1220.47.1006 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Kanada
        • 1220.47.1015 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal, Quebec, Kanada
        • 1220.47.1010 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Kanada
        • 1220.47.1014 Boehringer Ingelheim Investigational Site
  • Portoryko
      • San Juan, Portoryko
        • 1220.47.0034 Boehringer Ingelheim Investigational Site
  • Republika Korei
      • Pusan, Republika Korei
        • 1220.47.8204 Boehringer Ingelheim Investigational Site
      • Pusan, Republika Korei
        • 1220.47.8205 Boehringer Ingelheim Investigational Site
      • Seongnam, Republika Korei
        • 1220.47.8203 Boehringer Ingelheim Investigational Site
      • Seoul, Republika Korei
        • 1220.47.8202 Boehringer Ingelheim Investigational Site
      • Seoul, Republika Korei
        • 1220.47.8206 Boehringer Ingelheim Investigational Site
      • Seoul, Republika Korei
        • 1220.47.8207 Boehringer Ingelheim Investigational Site
      • Yangsan, Republika Korei
        • 1220.47.8201 Boehringer Ingelheim Investigational Site
  • Stany Zjednoczone
    • Alabama
      • Birmingham, Alabama, Stany Zjednoczone
        • 1220.47.0004 Boehringer Ingelheim Investigational Site
      • Birmingham, Alabama, Stany Zjednoczone
        • 1220.47.0045 Boehringer Ingelheim Investigational Site
      • Dothan, Alabama, Stany Zjednoczone
        • 1220.47.0050 Boehringer Ingelheim Investigational Site
    • Arizona
      • Phoenix, Arizona, Stany Zjednoczone
        • 1220.47.0061 Boehringer Ingelheim Investigational Site
    • Arkansas
      • North Little Rock, Arkansas, Stany Zjednoczone
        • 1220.47.0091 Boehringer Ingelheim Investigational Site
    • California
      • Bakersfield, California, Stany Zjednoczone
        • 1220.47.0008 Boehringer Ingelheim Investigational Site
      • Chula Vista, California, Stany Zjednoczone
        • 1220.47.0019 Boehringer Ingelheim Investigational Site
      • Coronado, California, Stany Zjednoczone
        • 1220.47.0010 Boehringer Ingelheim Investigational Site
      • La Jolla, California, Stany Zjednoczone
        • 1220.47.0033 Boehringer Ingelheim Investigational Site
      • La Mesa, California, Stany Zjednoczone
        • 1220.47.0035 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, Stany Zjednoczone
        • 1220.47.0011 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, Stany Zjednoczone
        • 1220.47.0014 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, Stany Zjednoczone
        • 1220.47.0100 Boehringer Ingelheim Investigational Site
      • Oceanside, California, Stany Zjednoczone
        • 1220.47.0018 Boehringer Ingelheim Investigational Site
      • Poway, California, Stany Zjednoczone
        • 1220.47.0059 Boehringer Ingelheim Investigational Site
      • San Diego, California, Stany Zjednoczone
        • 1220.47.0024 Boehringer Ingelheim Investigational Site
      • San Diego, California, Stany Zjednoczone
        • 1220.47.0037 Boehringer Ingelheim Investigational Site
      • San Francisco, California, Stany Zjednoczone
        • 1220.47.0031 Boehringer Ingelheim Investigational Site
    • Colorado
      • Englewood, Colorado, Stany Zjednoczone
        • 1220.47.0082 Boehringer Ingelheim Investigational Site
    • Connecticut
      • New Haven, Connecticut, Stany Zjednoczone
        • 1220.47.0049 Boehringer Ingelheim Investigational Site
    • Florida
      • Bradenton, Florida, Stany Zjednoczone
        • 1220.47.0057 Boehringer Ingelheim Investigational Site
      • Fort Lauderdale, Florida, Stany Zjednoczone
        • 1220.47.0078 Boehringer Ingelheim Investigational Site
      • Fort Lauderdale, Florida, Stany Zjednoczone
        • 1220.47.0086 Boehringer Ingelheim Investigational Site
      • Hialeah, Florida, Stany Zjednoczone
        • 1220.47.0054 Boehringer Ingelheim Investigational Site
      • Miami, Florida, Stany Zjednoczone
        • 1220.47.0088 Boehringer Ingelheim Investigational Site
      • Orlando, Florida, Stany Zjednoczone
        • 1220.47.0044 Boehringer Ingelheim Investigational Site
      • Orlando, Florida, Stany Zjednoczone
        • 1220.47.0099 Boehringer Ingelheim Investigational Site
      • Palm Harbor, Florida, Stany Zjednoczone
        • 1220.47.0095 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, Stany Zjednoczone
        • 1220.47.0074 Boehringer Ingelheim Investigational Site
    • Georgia
      • Atlanta, Georgia, Stany Zjednoczone
        • 1220.47.0022 Boehringer Ingelheim Investigational Site
      • Columbus, Georgia, Stany Zjednoczone
        • 1220.47.0039 Boehringer Ingelheim Investigational Site
      • Decatur, Georgia, Stany Zjednoczone
        • 1220.47.0052 Boehringer Ingelheim Investigational Site
    • Illinois
      • Chicago, Illinois, Stany Zjednoczone
        • 1220.47.0013 Boehringer Ingelheim Investigational Site
      • Chicago, Illinois, Stany Zjednoczone
        • 1220.47.0055 Boehringer Ingelheim Investigational Site
    • Indiana
      • Vaiparaiso, Indiana, Stany Zjednoczone
        • 1220.47.0062 Boehringer Ingelheim Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, Stany Zjednoczone
        • 1220.47.0085 Boehringer Ingelheim Investigational Site
      • Baton Rouge, Louisiana, Stany Zjednoczone
        • 1220.47.0087 Boehringer Ingelheim Investigational Site
      • New Orleans, Louisiana, Stany Zjednoczone
        • 1220.47.0101 Boehringer Ingelheim Investigational Site
    • Maryland
      • Baltimore, Maryland, Stany Zjednoczone
        • 1220.47.0064 Boehringer Ingelheim Investigational Site
      • Baltimore, Maryland, Stany Zjednoczone
        • 1220.47.0069 Boehringer Ingelheim Investigational Site
      • Chevy Chase, Maryland, Stany Zjednoczone
        • 1220.47.0067 Boehringer Ingelheim Investigational Site
      • Lutherville, Maryland, Stany Zjednoczone
        • 1220.47.0079 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Framingham, Massachusetts, Stany Zjednoczone
        • 1220.47.0027 Boehringer Ingelheim Investigational Site
      • Springfield, Massachusetts, Stany Zjednoczone
        • 1220.47.0065 Boehringer Ingelheim Investigational Site
    • Mississippi
      • Tulepo, Mississippi, Stany Zjednoczone
        • 1220.47.0023 Boehringer Ingelheim Investigational Site
    • Nevada
      • Las Vegas, Nevada, Stany Zjednoczone
        • 1220.47.0046 Boehringer Ingelheim Investigational Site
    • New Jersey
      • Neptune, New Jersey, Stany Zjednoczone
        • 1220.47.0066 Boehringer Ingelheim Investigational Site
    • New York
      • Bronx, New York, Stany Zjednoczone
        • 1220.47.0097 Boehringer Ingelheim Investigational Site
      • Brooklyn, New York, Stany Zjednoczone
        • 1220.47.0083 Boehringer Ingelheim Investigational Site
      • New York, New York, Stany Zjednoczone
        • 1220.47.0003 Boehringer Ingelheim Investigational Site
      • New York, New York, Stany Zjednoczone
        • 1220.47.0006 Boehringer Ingelheim Investigational Site
      • New York, New York, Stany Zjednoczone
        • 1220.47.0038 Boehringer Ingelheim Investigational Site
      • New York, New York, Stany Zjednoczone
        • 1220.47.0090 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Charlotte, North Carolina, Stany Zjednoczone
        • 1220.47.0053 Boehringer Ingelheim Investigational Site
      • Winston-Salem, North Carolina, Stany Zjednoczone
        • 1220.47.0021 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, Stany Zjednoczone
        • 1220.47.0098 Boehringer Ingelheim Investigational Site
    • Oregon
      • Portland, Oregon, Stany Zjednoczone
        • 1220.47.0028 Boehringer Ingelheim Investigational Site
      • Portland, Oregon, Stany Zjednoczone
        • 1220.47.0058 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Germantown, Tennessee, Stany Zjednoczone
        • 1220.47.0030 Boehringer Ingelheim Investigational Site
      • Jackson, Tennessee, Stany Zjednoczone
        • 1220.47.0072 Boehringer Ingelheim Investigational Site
      • Nashville, Tennessee, Stany Zjednoczone
        • 1220.47.0032 Boehringer Ingelheim Investigational Site
      • Nashville, Tennessee, Stany Zjednoczone
        • 1220.47.0041 Boehringer Ingelheim Investigational Site
    • Texas
      • Arlington, Texas, Stany Zjednoczone
        • 1220.47.0063 Boehringer Ingelheim Investigational Site
      • Austin, Texas, Stany Zjednoczone
        • 1220.47.0029 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, Stany Zjednoczone
        • 1220.47.0017 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, Stany Zjednoczone
        • 1220.47.0056 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, Stany Zjednoczone
        • 1220.47.0071 Boehringer Ingelheim Investigational Site
      • Fort Worth, Texas, Stany Zjednoczone
        • 1220.47.0060 Boehringer Ingelheim Investigational Site
      • Forth Worth, Texas, Stany Zjednoczone
        • 1220.47.0081 Boehringer Ingelheim Investigational Site
      • Houston, Texas, Stany Zjednoczone
        • 1220.47.0009 Boehringer Ingelheim Investigational Site
      • Houston, Texas, Stany Zjednoczone
        • 1220.47.0068 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, Stany Zjednoczone
        • 1220.47.0016 Boehringer Ingelheim Investigational Site
    • Vermont
      • Burlington, Vermont, Stany Zjednoczone
        • 1220.47.0015 Boehringer Ingelheim Investigational Site
    • Virginia
      • Annandale, Virginia, Stany Zjednoczone
        • 1220.47.0042 Boehringer Ingelheim Investigational Site
      • Falls Church, Virginia, Stany Zjednoczone
        • 1220.47.0043 Boehringer Ingelheim Investigational Site
      • Richmond, Virginia, Stany Zjednoczone
        • 1220.47.0026 Boehringer Ingelheim Investigational Site
    • Washington
      • Seattle, Washington, Stany Zjednoczone
        • 1220.47.0092 Boehringer Ingelheim Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, Stany Zjednoczone
        • 1220.47.0073 Boehringer Ingelheim Investigational Site
  • Tajwan
      • Kaohsiung, Tajwan
        • 1220.47.8803 Boehringer Ingelheim Investigational Site
      • Kaohsiung, Tajwan
        • 1220.47.8804 Boehringer Ingelheim Investigational Site
      • Taichung, Tajwan
        • 1220.47.8802 Boehringer Ingelheim Investigational Site
      • Taipei, Tajwan
        • 1220.47.8801 Boehringer Ingelheim Investigational Site
      • Taipei, Tajwan
        • 1220.47.8805 Boehringer Ingelheim Investigational Site

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 70 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion criteria:

  1. Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening in addition to:

    1. positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening; or,
    2. liver biopsy consistent with chronic HCV infection.
  2. HCV genotype 1 infection confirmed by genotypic testing at screening.
  3. Therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral / immunomodulatory drug for acute or chronic HCV infection.
  4. HCV RNA = 1,000 IU/mL at screening

  5. Documentation of a liver biopsy within 3 years or fibroscan within 6 months of the screening visit.

    Note: If cirrhosis has been previously demonstrated on a biopsy, then biopsies obtained more than 3 years before enrolment need not be repeated. Biopsies can be waived for patients who would be placed at risk from the procedure. Inability to do a liver biopsy should not exclude patients from a trial.

  6. Age 18 to 70 years

  7. Female patients:

    (c) with documented hysterectomy, (d) who have had both ovaries removed, (e) with documented tubal ligation, (f) who are post-menopausal with last menstrual period at least 12 months prior to screening, or (g) of childbearing potential with a negative serum pregnancy test at screening and Day 1, that, if sexually active, agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin in addition to the consistent and correct use of a condom. Patients must agree not to breast-feed at any time from the date of screening until 7 months after the last dose of ribavirin.

    Medically accepted methods of contraception for females in this trial are ethinyl estradiol-containing contraceptives, diaphragm with spermicide substance and intra-uterine device.

    Male patients:

    1. who are documented to be sterile, or
    2. who are without pregnant female partner(s) and consistently and correctly use a condom while their female partner(s) (if of child-bearing potential) use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin. It is in the responsibility of the male patient to ensure that his partner(s) is not pregnant prior to screening into the study or becomes pregnant during the treatment and the observation phase.
  8. Signed informed consent form prior to trial participation

Exclusion criteria:

  1. HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
  2. Evidence of acute or chronic liver disease due to causes other than chronic HCV infection.
  3. HIV co-infection.
  4. Hepatitis B virus (HBV) infection based on presence of HBs-Ag.
  5. Active malignancy, or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix)
  6. Active or, history of alcohol or illicit drug abuse other than cannabis within the past 12 months
  7. A condition that is defined as one which in the opinion of investigator may put the patient at risk because of participation in this study, may influence the results of this study, or limit the patient¿s ability to participate in this study.
  8. Usage of any investigational drugs within 28 days prior to screening, or planned usage of an investigational drug during the course of this study.
  9. Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 28 days prior to screening. Patients being treated with oral antivirals such as acyclovir, famciclovir or valacyclovir for recurrent herpes simplex infection; or with oseltamivir or zanamivir for influenza A infection, may be screened.
  10. Received silymarin (milk thistle), glycyrrhizin, or Sho-saiko-to (SST) within 28 days prior to screening and throughout the treatment phase.
  11. Known hypersensitivity to any ingredient of the study drugs.
  12. Alpha fetoprotein value >100 ng/mL at screening; if >20 ng/mL and =100 ng/mL, patients may be included if there is no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, CT scan, or MRI) within last 6 months prior to randomization (Visit 2).

  13. Decompensated liver disease, or history of decompensated liver disease, as defined by the presence of: hepatic encephalopathy, ascites, or esophageal variceal bleeding and/or laboratory results of any of the following:

    1. International normalized ratio (INR) of =1.7
    2. Serum Albumin =3.5 g/dL
    3. Serum total bilirubin =2.0 mg/dL (except when the increase is predominately due to unconjugated bilirubin and related to Gilberts syndrome).
  14. Pre-existing psychiatric condition that could interfere with the subject¿s participation in and completion of the study including but not limited to prior suicidal attempt, schizophrenia, major depression syndrome, severe anxiety, severe personality disorder, a period of disability or impairment due to a psychiatric disease within the past 5 years.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: Placebo
Lek: Placebo
Aktywny komparator: PegIFN/RBV
48 weeks
Lek: PegIFN/RBV
Eksperymentalny: BI 201335 for 24 weeks
BI 201 335 QD dosing in combination with IFN/RBV
Lek: PegIFN/RBV
Lek: BI201335
QD BI 201335
Lek: BI201335
QD (once daily) BI 201335
Eksperymentalny: BI201335 for 12 weeks
BI 201335 QD doing in combination with PEFG IFN/RBV
Lek: PegIFN/RBV
Lek: BI201335
QD BI 201335
Lek: BI201335
QD (once daily) BI 201335

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
Ramy czasowe: 12 weeks post treatment, up to 60 weeks
Percentage of participants with sustained virologic response 12 weeks post treatment (SVR12) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
12 weeks post treatment, up to 60 weeks

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Sustained Virologic Response 24 Weeks Post-treatment (SVR24)
Ramy czasowe: 24 weeks post treatment, up to 72 weeks

Percentage of participants with sustained virologic response 24 weeks post-treatment (SVR24), defined as plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.

Hepatitis C virus Ribonucleic acid (HCV RNA)
24 weeks post treatment, up to 72 weeks
Early Treatment Success (ETS)
Ramy czasowe: Week 4 and week 8
Percentage of participants with early treatment success (ETS), defined as a plasma HCV RNA level <25 IU/mL (detected or undetected) at week 4 and HCV RNA <25 IU/mL (undetected) at week 8.
Week 4 and week 8
ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES
Ramy czasowe: 12 weeks post treatment, up to 60 weeks
The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients have sustained virological response 12 weeks post-treatment. BL = Baseline
12 weeks post treatment, up to 60 weeks
ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO
Ramy czasowe: 12 weeks post treatment, up to 60 weeks
The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline
12 weeks post treatment, up to 60 weeks
ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES
Ramy czasowe: 12 weeks post treatment, up to 60 weeks
The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline
12 weeks post treatment, up to 60 weeks
ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO
Ramy czasowe: 12 weeks post treatment, up to 60 weeks
The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline
12 weeks post treatment, up to 60 weeks
AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES
Ramy czasowe: 12 weeks post treatment, up to 60 weeks
The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline
12 weeks post treatment, up to 60 weeks
AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO
Ramy czasowe: 12 weeks post treatment, up to 60 weeks
The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline
12 weeks post treatment, up to 60 weeks
AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES
Ramy czasowe: 12 weeks post treatment, up to 60 weeks
The number of participants with aspartate aminotransferase (AST) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline
12 weeks post treatment, up to 60 weeks
AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO
Ramy czasowe: 12 weeks post treatment, up to 60 weeks
The number of participants with aspartate aminotransferase (AST) in normal range 12 weeks post-treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline
12 weeks post treatment, up to 60 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Boehringer Ingelheim

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 kwietnia 2011

Zakończenie podstawowe (Rzeczywisty)

1 kwietnia 2014

Ukończenie studiów (Rzeczywisty)

1 kwietnia 2014

Daty rejestracji na studia

Pierwszy przesłany

15 lutego 2011

Pierwszy przesłany, który spełnia kryteria kontroli jakości

15 lutego 2011

Pierwszy wysłany (Oszacować)

16 lutego 2011

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

18 września 2015

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

18 sierpnia 2015

Ostatnia weryfikacja

1 sierpnia 2015

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 1220.47
  • 2010-021716-42 (Numer EudraCT: EudraCT)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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