- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02278419
An Efficacy and Safety Study of a 8 or 12-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive and Experienced Participants With Chronic Genotype 4 Hepatitis C Virus Infection
2016년 10월 13일 업데이트: Janssen-Cilag International NV
A Phase 2a, Partly Randomized, Open-label Trial to Investigate the Efficacy and Safety of an 8 or 12-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive and Experienced Subjects With Chronic Genotype 4 Hepatitis C Infection
The purpose of this study is to evaluate the efficacy of simeprevir in combination with sofosbuvir for 8 or 12 weeks versus a historical control, with respect to the percentage of participants with sustained virologic response at 12 weeks after end of treatment (SVR12) in the overall population.
연구 개요
상세 설명
This is a partly randomized, open-label (identity of study drug will be known to volunteer and study staff), multicenter (when more than one hospital or medical school team work on a medical research study) study.
The study will consist of a screening period of up to 4 weeks, an open-label treatment period of 8 weeks or 12 weeks, and a post-treatment follow-up period until 24 weeks after end of treatment (EOT).
Participants without cirrhosis will be assigned to Group A wherein half of the participants will receive 8 week treatment in Group A1 and remaining participants will receive 12 week treatment in Group A2.
Participants with cirrhosis, will be assigned to Group B to receive simeprevir in combination with sofosbuvir for 12 weeks.
The duration of participation for each participant, including the screening period, will be approximately 36 or 40 weeks for 8 or 12 week treatment, respectively.
Efficacy will be primarily assessed by percentage of participants with SVR12.
Participants' safety will be evaluated throughout the study.
연구 유형
중재적
등록 (실제)
63
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Cairo, 이집트
-
Menoufiya, 이집트
-
-
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
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Participant must have hepatitis C virus (HCV) genotype 4 infection (confirmed at screening)
- Participant must have HCV ribonucleic acid (RNA) greater than (>) 10,000 international unit per milliliter (IU/mL) at screening
- In participants with cirrhosis, a documented hepatic imaging procedure (ultrasound, computed tomography [CT] scan, or magnetic resonance imaging [MRI]) within 6 months before baseline (Day 1) to exclude hepatocellular carcinoma is required
- A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin at screening and a negative urine pregnancy test on Day 1 before first dose of study drug
- Females of childbearing potential or males with a female partner of childbearing potential must agree to use 2 highly effective contraceptive methods (one of which is a barrier method; eg, condom or diaphragm) from Day 1 (baseline) and continue until 30 days after the end of treatment (EOT) (or longer if dictated by local regulations), or not be heterosexually active, or be a vasectomized male subject or a female subject with a vasectomized partner, or be a female (subject or partner of male subject) of non-childbearing potential (ie, postmenopausal for at least 2 years or surgically sterile)
Exclusion Criteria:
- Participant has evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices, or hepatic encephalopathy)
- Participant has any liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A, drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or any other non-HCV liver disease considered clinically significant by the investigator
- Participant is infected/co-infected with non-genotype 4 HCV
- Participant has any other active clinically significant disease or clinically significant findings during screening of medical history, physical examination, laboratory testing or electrocardiogram (ECG) recordings that, in the investigator's opinion, would compromise the participant's safety or could interfere with the participant participating in and completing the study
- Participant has history of malignancy within 5 years of the screening visit (exceptions: skin carcinomas, carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence)
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 |
|---|---|
|
실험적: Group A1
Participants without cirrhosis will receive simeprevir 150 milligram (mg) capsule along with sofosbuvir 400 mg tablet, orally, once daily for 8 weeks.
|
Simeprevir 150 mg capsule orally, once daily for 8 weeks in Group A1, 12 weeks in Group A2 and Group B.
Sofosbuvir 400 mg tablet orally, once daily for 8 weeks in Group A1, 12 weeks in Group A2 and Group B.
|
|
실험적: Group A2
Participants without cirrhosis will receive simeprevir 150 mg capsule along with sofosbuvir 400 mg tablet, orally, once daily for 12 weeks.
|
Simeprevir 150 mg capsule orally, once daily for 8 weeks in Group A1, 12 weeks in Group A2 and Group B.
Sofosbuvir 400 mg tablet orally, once daily for 8 weeks in Group A1, 12 weeks in Group A2 and Group B.
|
|
실험적: Group B
Participants with cirrhosis will receive simeprevir 150 mg capsule along with sofosbuvir 400 mg tablet, orally, once daily for 12 weeks.
|
Simeprevir 150 mg capsule orally, once daily for 8 weeks in Group A1, 12 weeks in Group A2 and Group B.
Sofosbuvir 400 mg tablet orally, once daily for 8 weeks in Group A1, 12 weeks in Group A2 and Group B.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response at Week 12 After End of Treatment (SVR12)
기간: 12 weeks after end of treatment (EOT) (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)
|
SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]), detectable or undetectable at 12 weeks after EOT.
|
12 weeks after end of treatment (EOT) (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response at Week 4 After End of Treatment (SVR4)
기간: 4 weeks after EOT (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)
|
SVR4 is defined as HCV RNA <LLOQ;15 IU/mL, at 4 weeks after EOT.
|
4 weeks after EOT (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)
|
|
Percentage of Participants With Sustained Virologic Response at Week 24 After End of Treatment (SVR24)
기간: 24 weeks after EOT (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)
|
SVR24 is defined as HCV RNA <LLOQ;15 IU/mL, at 24 weeks after EOT.
|
24 weeks after EOT (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)
|
|
Percentage of Participants With on-treatment Failure
기간: EOT (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)
|
Participants will be considered on-treatment failures if they have (confirmed) detectable HCV RNA, that is <LLOQ;15 IU/mL, detectable or greater than or equal to (>=) LLOQ at EOT.
|
EOT (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)
|
|
Percentage of Participants With Viral Relapse
기간: EOT (Week 8 for Group A1, Week 12 for Group A2 and Group B), Weeks 4, 12 and 24 after end of treatment
|
Participants will be considered to have viral relapse if they do not achieve SVR at Week 4, 12 and 24 after EOT and meet the following conditions 1) HCV RNA <LLOQ;15 IU/mL, undetectable at EOT, 2) HCV RNA >=LLOQ;15 IU/mL during the follow-up period.
|
EOT (Week 8 for Group A1, Week 12 for Group A2 and Group B), Weeks 4, 12 and 24 after end of treatment
|
|
Percentage of Participants With On-treatment Response
기간: Week 1, 2, 4, 8 and EOT for all groups, Week 12 for Group A2 and Group B
|
On-treatment virologic response is defined as the change from baseline in log10 hepatitis C virus ribonucleic acid.
|
Week 1, 2, 4, 8 and EOT for all groups, Week 12 for Group A2 and Group B
|
|
Percentage of Participants With Viral Breakthrough
기간: Week 1 up to Week 8 in Group A1, Week 1 up to Week 12 in Group A2 and Group B
|
Viral breakthrough is defined as confirmed >1.0 log10 increase in HCV RNA from nadir or confirmed HCV RNA >100 IU/mL in participants who had previously achieved HCV RNA <LLOQ; 15 IU/mL.
|
Week 1 up to Week 8 in Group A1, Week 1 up to Week 12 in Group A2 and Group B
|
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.
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
2014년 12월 1일
기본 완료 (실제)
2015년 10월 1일
연구 완료 (실제)
2015년 10월 1일
연구 등록 날짜
최초 제출
2014년 10월 28일
QC 기준을 충족하는 최초 제출
2014년 10월 28일
처음 게시됨 (추정)
2014년 10월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 10월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 10월 13일
마지막으로 확인됨
2016년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CR104970
- TMC435HPC2014 (기타 식별자: Janssen-Cilag International NV)
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. .
C 형 간염에 대한 임상 시험
-
University Hospital, GrenobleClinical Investigation Centre for Innovative Technology Network완전한
-
Meir Medical Center완전한디지털 스테레오 광 디스크 이미지에서 C/D 비율을 측정하는 새로운 기술 개발 | C/D 측정의 관찰자 내 재현성 | C/D 측정의 관찰자 간 가변성
-
University Hospital, Bordeaux아직 모집하지 않음
-
University Hospital, Caen완전한
-
University of Sao Paulo General HospitalInCor Heart Institute; Chinese Academy of Medical Sciences, Fuwai Hospital; Beneficência... 그리고 다른 협력자들알려지지 않은