Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection
2015년 12월 22일 업데이트: Boehringer Ingelheim
Safety, Antiviral Effect and Pharmacokinetics of BI 207127 in Combination With BI 201335 and With or Without Ribavirin for 4, 16, 24, 28 or 40 Weeks in Patients With Chronic HCV Genotype 1 Infection (Randomized Phase Ib/II)
The substances BI 201335 and BI 207127 are being developed for the treatment of chronic hepatitis C virus infection. BI 201335 and BI 207127 work by preventing the virus from replicating.
The currently available medications pegylated interferon alfa and ribavirin for hepatitis C ca have considerable adverse events in patients and in many cases are not sufficiently effective. This is particularly the case in treatment of patients infected with genotype 1 of HCV.
A combination therapy of these new substances without pegylated interferon alfa may be associated with fewer adverse events that currently available (pegylated interferon-alfa-based) medication and may also provide a treatment option to the large number of patients with contraindications or intolerance to pegylated interferon alfa.
This clinical trial (1241.21) currently consists of 3 distinct studies: Part 1, Part 2 and Part 3.
Part 1 (SOUND-C1) is a 2 armed study as described in experimental arms 1 and 2 below (actual enrollment: 56 patients; randomized and treated: 32) Part 2 (SOUND-C2) is a 5 armed study as described in experimental arms 3 to 7 below (actual enrollment: 465; randomized and treated: 362) Part 3 (SOUND-C3) includes 3 arms as described in experimental arms 8 to 10 below (83 patients randomized and treated)
연구 개요
상태
완전한
정황
개입 / 치료
연구 유형
중재적
등록 (실제)
488
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Auckland NZ, 뉴질랜드
- 1241.21.64001 Boehringer Ingelheim Investigational Site
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Berlin, 독일
- 1241.21.49002 Boehringer Ingelheim Investigational Site
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Berlin, 독일
- 1241.21.49003 Boehringer Ingelheim Investigational Site
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Düsseldorf, 독일
- 1241.21.49007 Boehringer Ingelheim Investigational Site
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Esslingen, 독일
- 1241.21.49005 Boehringer Ingelheim Investigational Site
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Frankfurt am Main, 독일
- 1241.21.49001 Boehringer Ingelheim Investigational Site
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Hamburg, 독일
- 1241.21.49006 Boehringer Ingelheim Investigational Site
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Hannover, 독일
- 1241.21.49009 Boehringer Ingelheim Investigational Site
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Leipzig, 독일
- 1241.21.49004 Boehringer Ingelheim Investigational Site
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Mainz, 독일
- 1241.21.49008 Boehringer Ingelheim Investigational Site
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Bucharest, 루마니아
- 1241.21.40001 Boehringer Ingelheim Investigational Site
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Bucharest, 루마니아
- 1241.21.40002 Boehringer Ingelheim Investigational Site
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Bucharest, 루마니아
- 1241.21.40003 Boehringer Ingelheim Investigational Site
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California
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La Jolla, California, 미국
- 1241.21.0003 Boehringer Ingelheim Investigational Site
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San Diego, California, 미국
- 1241.21.0006 Boehringer Ingelheim Investigational Site
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San Francisco, California, 미국
- 1241.21.0004 Boehringer Ingelheim Investigational Site
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Florida
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Palm Harbor, Florida, 미국
- 1241.21.0011 Boehringer Ingelheim Investigational Site
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Indiana
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Valparaiso, Indiana, 미국
- 1241.21.0013 Boehringer Ingelheim Investigational Site
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Massachusetts
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Springfield, Massachusetts, 미국
- 1241.21.0008 Boehringer Ingelheim Investigational Site
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North Carolina
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Fayetteville, North Carolina, 미국
- 1241.21.0019 Boehringer Ingelheim Investigational Site
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Texas
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Arlington, Texas, 미국
- 1241.21.0012 Boehringer Ingelheim Investigational Site
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Austin, Texas, 미국
- 1241.21.0005 Boehringer Ingelheim Investigational Site
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Dallas, Texas, 미국
- 1241.21.0007 Boehringer Ingelheim Investigational Site
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Houston, Texas, 미국
- 1241.21.0010 Boehringer Ingelheim Investigational Site
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Washington
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Seattle, Washington, 미국
- 1241.21.0017 Boehringer Ingelheim Investigational Site
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Basel, 스위스
- 1241.21.41003 Boehringer Ingelheim Investigational Site
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Bern, 스위스
- 1241.21.41006 Boehringer Ingelheim Investigational Site
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St. Gallen, 스위스
- 1241.21.41001 Boehringer Ingelheim Investigational Site
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Zürich, 스위스
- 1241.21.41002 Boehringer Ingelheim Investigational Site
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Barcelona, 스페인
- 1241.21.34002 Boehringer Ingelheim Investigational Site
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Barcelona, 스페인
- 1241.21.34005 Boehringer Ingelheim Investigational Site
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Madrid, 스페인
- 1241.21.34003 Boehringer Ingelheim Investigational Site
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Madrid, 스페인
- 1241.21.34004 Boehringer Ingelheim Investigational Site
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Majadahonda-Madrid, 스페인
- 1241.21.34001 Boehringer Ingelheim Investigational Site
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Valencia, 스페인
- 1241.21.34006 Boehringer Ingelheim Investigational Site
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Linz, 오스트리아
- 1241.21.43003 Boehringer Ingelheim Investigational Site
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Wien, 오스트리아
- 1241.21.43001 Boehringer Ingelheim Investigational Site
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Wien, 오스트리아
- 1241.21.43002 Boehringer Ingelheim Investigational Site
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Aveiro, 포르투갈
- 1241.21.35103 Boehringer Ingelheim Investigational Site
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Coimbra, 포르투갈
- 1241.21.35104 Boehringer Ingelheim Investigational Site
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Lisboa, 포르투갈
- 1241.21.35101 Boehringer Ingelheim Investigational Site
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Lisboa, 포르투갈
- 1241.21.35105 Boehringer Ingelheim Investigational Site
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Porto, 포르투갈
- 1241.21.35102 Boehringer Ingelheim Investigational Site
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Clichy, 프랑스
- 1241.21.33005 Boehringer Ingelheim Investigational Site
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Grenoble cédex 9, 프랑스
- 1241.21.33007 Boehringer Ingelheim Investigational Site
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Lyon, 프랑스
- 1241.21.33003 Boehringer Ingelheim Investigational Site
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Marseille, 프랑스
- 1241.21.33001 Boehringer Ingelheim Investigational Site
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Montpellier, 프랑스
- 1241.21.33002 Boehringer Ingelheim Investigational Site
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Paris, 프랑스
- 1241.21.33004 Boehringer Ingelheim Investigational Site
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Paris, 프랑스
- 1241.21.33008 Boehringer Ingelheim Investigational Site
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Vandoeuvre Cedex, 프랑스
- 1241.21.33006 Boehringer Ingelheim Investigational Site
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Victoria
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Heidelberg, Victoria, 호주
- 1241.21.61002 Boehringer Ingelheim Investigational Site
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Melbourne, Victoria, 호주
- 1241.21.61001 Boehringer Ingelheim Investigational Site
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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:
- Chronic hepatitis C virus (HCV) infection of genotype (GT) 1
- Parts 1-3:Treatment naive to Interferon -alfa (IFN), Pegylated interferon -alfa (PegIFN), ribavirin (RBV), and any direct acting antiviral agent for chronic hepatitis C
- Part 4: Treatment experienced with confirmed prior virological failure to an approved dose of PegIFN/RBV (null-response)
- HCV RNA >=10,000 IU/mL at screening
- Liver biopsy within two years or fibroscan within six months prior to baseline
- Liver biopsy within two years or fibroscan within 6 months prior to screening
- Age 18-75 years
Exclusion criteria:
- Hepatitis C virus (HCV) infection of mixed genotype
- Evidence of liver disease due to causes other than chronic HCV infection
- Positive ELISA for human immunodeficiency virus (HIV)
- Hepatitis B virus (HBV) infection
- Decompensated liver disease or history of decompensated liver disease
- Active or suspected malignancy within the last 5 years
- Ongoing or historical photosensitivity or recurrent rash
- History of alcohol or drug abuse (except cannabis) within the past 12 months
- Body mass index (BMI)I <18 or > 35 kg/m2
- Usage of any investigational drugs within 30 days prior to enrolment, or 5 half-lives, whichever is longer; o the planned usage of an investigational drug during the course of the current study
- Known hypersensitivity to any ingredient of the study drugs
- A condition that is defined as one which in the opinion of the investigator may interfere with the patient's capability for participation in the trial or may influence the results of the trial
- Alpha fetoprotein >100ng/mL at screening; if >20ng/mL and <=100ng/mL, patients can be included if there is no evidence of liver cancer in an appropriate imaging study within 6 months prior to randomisation
- Total bilirubin > 2 mg/dL with ratio of direct/indirect > 1
- AST or ALT >5xULN
- INR prolonged to >1.7xULN
- Requirement for chronic systemic corticosteroids
- Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to enrolment or 5 half-lives, whichever is longer
- Received silymarin or glycyrrhizin or Sho-saiko-to within 30 days prior to enrolment
- Contraindications pertaining to PegIFN or RBV
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: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 2
4 weeks of high dose TID BI 207127 and QD BI 201335 in combination with RBV, Part 1
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28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
|
|
실험적: 1
4 weeks of low dose three times per day (TID) BI 207127 and once daily (QD) BI 201335 in combination with RBV, Part 1
|
28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
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실험적: 3
16 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
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28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
|
|
실험적: 4
28 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
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28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
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실험적: 5
40 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
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28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
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실험적: 6
28 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 2
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40 weeks, QD
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
48 weeks, according to label
40 weeks, according to label
28 weeks, QD
16 weeks, QD
24 weeks, according to label
28 weeks, high dose BID
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실험적: 7
28 weeks of TID BI 207127 and QD BI 201335 without RBV, Part 2
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28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
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실험적: 8
16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3
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28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
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실험적: 9
24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3
|
28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
|
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실험적: 10
24 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 3
|
28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
|
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실험적: 11
16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4
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28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
|
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실험적: 12
24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4
|
28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Part 1: Rapid Virological Response (RVR)
기간: 4 weeks
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Part 1: Rapid virological response (RVR), defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) <25IU/mL at Week 4 of treatment
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4 weeks
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Part 2: Sustained Virological Response (SVR)
기간: From drug administration until 12 weeks after end of treatment, up to 52 weeks
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Part 2: Sustained virological response (SVR), defined as HCV RNA <25 IU/mL and undetectable at 12 weeks after end of treatment
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From drug administration until 12 weeks after end of treatment, up to 52 weeks
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Part 3 and 4: Sustained Virological Response (SVR)
기간: From drug administration until 12 weeks after end of treatment, up to 36 weeks
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Part 3 and 4: Sustained virological response (SVR) defined as HCV RNA <25IU/mL and undetectable at 12 weeks after end of treatment
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From drug administration until 12 weeks after end of treatment, up to 36 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Part 1: Time to Virological Response
기간: From drug administration until end of drug administration, up to 4 weeks
|
Part 1: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL.
The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.
|
From drug administration until end of drug administration, up to 4 weeks
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Part 2: Time to Virological Response
기간: From drug administration until end of drug administration, up to 40 weeks
|
Part 2: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL.
The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.
|
From drug administration until end of drug administration, up to 40 weeks
|
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Part 1 and 2: Plasma HCV RNA Level Not Detectable at Week 4
기간: 4 weeks
|
Part 1 and 2: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level not detectable at Week 4
|
4 weeks
|
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Part 2: Sustained Virological Response at 4 and 24 Weeks After End of Treatment
기간: 4 weeks and 24 weeks after the end of treatment, up to 64 weeks
|
Part 2: Sustained virological response at 4 and 24 weeks after end of treatment
|
4 weeks and 24 weeks after the end of treatment, up to 64 weeks
|
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Part 3 and 4: Plasma HCV RNA Level <25 IU/mL at Week 4 and 12 of Treatment
기간: Week 4 and 12
|
Part 3 and 4: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level <25 IU/mL at week 4 and 12 of treatment
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Week 4 and 12
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Part 3 and 4: Sustained Virological Response (SVR) at 4 Weeks After End of Treatment
기간: up to 28 weeks
|
Part 3 and 4: Sustained virological response (SVR) at 4 weeks after end of treatment
|
up to 28 weeks
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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
- Zeuzem S, Mantry P, Soriano V, Buynak RJ, Dufour JF, Pockros PJ, Wright D, Angus P, Buti M, Stern JO, Kadus W, Vinisko R, Bocher W, Mensa FJ. Short article: Faldaprevir, deleobuvir and ribavirin in IL28B non-CC patients with HCV genotype-1a infection included in the SOUND-C3 phase 2b study. Eur J Gastroenterol Hepatol. 2016 Aug;28(8):923-6. doi: 10.1097/MEG.0000000000000649.
- Asselah T, Zeuzem S, Soriano V, Bronowicki JP, Lohse AW, Mullhaupt B, Schuchmann M, Bourliere M, Buti M, Roberts SK, Gane EJ, Stern JO, Voss F, Baum P, Gallivan JP, Bocher WO, Mensa FJ. ITPA Genotypes Predict Anemia but Do Not Affect Virological Response with Interferon-Free Faldaprevir, Deleobuvir, and Ribavirin for HCV Infection. PLoS One. 2015 Dec 9;10(12):e0144004. doi: 10.1371/journal.pone.0144004. eCollection 2015.
- Zeuzem S, Soriano V, Asselah T, Gane EJ, Bronowicki JP, Angus P, Lohse AW, Stickel F, Mullhaupt B, Roberts S, Schuchmann M, Manns M, Bourliere M, Buti M, Stern JO, Gallivan JP, Voss F, Sabo JP, Bocher W, Mensa FJ; SOUND-C2 Study Group. Efficacy and safety of faldaprevir, deleobuvir, and ribavirin in treatment-naive patients with chronic hepatitis C virus infection and advanced liver fibrosis or cirrhosis. Antimicrob Agents Chemother. 2015 Feb;59(2):1282-91. doi: 10.1128/AAC.04383-14. Epub 2014 Dec 15.
- Zeuzem S, Soriano V, Asselah T, Bronowicki JP, Lohse AW, Mullhaupt B, Schuchmann M, Bourliere M, Buti M, Roberts SK, Gane EJ, Stern JO, Vinisko R, Kukolj G, Gallivan JP, Bocher WO, Mensa FJ. Faldaprevir and deleobuvir for HCV genotype 1 infection. N Engl J Med. 2013 Aug 15;369(7):630-9. doi: 10.1056/NEJMoa1213557.
- Zeuzem S, Asselah T, Angus P, Zarski JP, Larrey D, Mullhaupt B, Gane E, Schuchmann M, Lohse AW, Pol S, Bronowicki JP, Roberts S, Arasteh K, Zoulim F, Heim M, Stern JO, Nehmiz G, Kukolj G, Bocher WO, Mensa FJ. Faldaprevir (BI 201335), deleobuvir (BI 207127) and ribavirin oral therapy for treatment-naive HCV genotype 1: SOUND-C1 final results. Antivir Ther. 2013;18(8):1015-9. doi: 10.3851/IMP2567. Epub 2013 Apr 4.
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
2010년 5월 1일
기본 완료 (실제)
2014년 10월 1일
연구 완료 (실제)
2014년 10월 1일
연구 등록 날짜
최초 제출
2010년 5월 3일
QC 기준을 충족하는 최초 제출
2010년 5월 26일
처음 게시됨 (추정)
2010년 5월 28일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 2월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 12월 22일
마지막으로 확인됨
2015년 12월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1241.21
- 2009-018197-66 (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. .