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

Phase 2 Study of Yimitasvir Phosphate Capsules

2020년 3월 16일 업데이트: 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

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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".

연구 유형

중재적

등록 (실제)

129

단계

  • 2 단계

연락처 및 위치

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

연구 장소

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

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 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

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: SOF+DAG181 100 mg
Patients with genotype 1 HCV infection without cirrhosis will receive SOF+DAG181 100 mg for 12 weeks.
의약품: 소프
400 mg 정제를 1일 1회 경구 투여
다른 이름들:
  • 소포스부비르
  • 소발디®
의약품: DAG181
Capsule administered orally once daily
다른 이름들:
  • 이미타스비르
실험적: SOF+DAG181 200 mg
Patients with genotype 1 HCV infection without cirrhosis will receive SOF+DAG181 200 mg for 12 weeks.
의약품: 소프
400 mg 정제를 1일 1회 경구 투여
다른 이름들:
  • 소포스부비르
  • 소발디®
의약품: DAG181
Capsule administered orally once daily
다른 이름들:
  • 이미타스비르

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of subjects with sustained virologic response 12 weeks after discontinuation of therapy (SVR12)
기간: 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.
기간: Up to posttreatment week 24
Up to posttreatment week 24

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of subjects with sustained virologic response 4, 8 and 24 weeks after discontinuation of therapy (SVR4,SVR8 and SVR24)
기간: 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
기간: Baseline to week 12
Baseline to week 12
The time to first achieve "HCV RNA < the lower limit of quantitation (LLOQ)" while on treatment
기간: Baseline to week 12
Baseline to week 12
HCV RNA change from baseline
기간: Up to posttreatment week 24
Up to posttreatment week 24
Percentage of subjects with virologic failure
기간: 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
기간: Up to posttreatment week 24
Viral resistance to DAG181 and/or SOF during treatment and after cessation of treatment
Up to posttreatment week 24

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Sunshine Lake Pharma Co., Ltd.

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 (실제)

2017년 7월 31일

기본 완료 (실제)

2018년 5월 8일

연구 완료 (실제)

2018년 9월 26일

연구 등록 날짜

최초 제출

2018년 2월 10일

QC 기준을 충족하는 최초 제출

2018년 3월 1일

처음 게시됨 (실제)

2018년 3월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 3월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 3월 16일

마지막으로 확인됨

2020년 3월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • PCD-DDAG181PA-16-005

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .

만성 HCV 감염에 대한 임상 시험

소프에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Peru

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다