이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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)

2015년 8월 18일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

658

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 위약
의약품: 위약
활성 비교기: PegIFN/RBV
48 weeks
의약품: PegIFN/RBV
실험적: BI 201335 for 24 weeks
BI 201 335 QD dosing in combination with IFN/RBV
의약품: PegIFN/RBV
의약품: BI201335
QD BI 201335
의약품: BI201335
QD (once daily) BI 201335
실험적: BI201335 for 12 weeks
BI 201335 QD doing in combination with PEFG IFN/RBV
의약품: PegIFN/RBV
의약품: BI201335
QD BI 201335
의약품: BI201335
QD (once daily) BI 201335

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Sustained Virologic Response 24 Weeks Post-treatment (SVR24)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Boehringer Ingelheim

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2011년 4월 1일

기본 완료 (실제)

2014년 4월 1일

연구 완료 (실제)

2014년 4월 1일

연구 등록 날짜

최초 제출

2011년 2월 15일

QC 기준을 충족하는 최초 제출

2011년 2월 15일

처음 게시됨 (추정)

2011년 2월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 9월 18일

QC 기준을 충족하는 마지막 업데이트 제출

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추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

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

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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