- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02282709
Effect of ASV and DCV Therapy on the Quality of Immune Status in Chronic HCV Patients (ImmunoDual)
Rationale: Chronic HCV infection is characterised by a weak HCV specific CD8+ T cell response, due to continuous pressure of high viral load. Treatment of chronic HCV patients with ASV and DCV will result in a significant drop in HCV viral load. At present, no information is available on the immunological effects of treatment with ASV and DCV, nor on the early effects of viral load reduction caused by a compound that is thought not to possess direct immunomodulatory effects. This information will be crucial for a better understanding of the mechanisms that may limit the effectiveness of treatment, occurrence of viral rebound or relapses during, at the end of treatment or during the follow up period.
Objective: To evaluate in detail the functionality of immune cells in blood in chronic HCV patients before, during and after treatment with ASV and DCV, in an IFN-free regimen.
Study design: This is an investigator-initiated single center open label study with one arm of 12 patients.
Study population: Adult chronic HCV patients with genotype 1b, who are previous non-responders to the treatment.
Intervention (if applicable): All patients will be treated with twice daily a 200 mg oASV and once daily a 60 mg DCV for 24 weeks.
Main study parameters/endpoints:
- Phenotype and function of blood leukocytes during treatment; frequency of HCV-specific T cells, NK cells and monocytes
- Gene expression levels of leukocyte populations before, during and after treatment
- Gene expression levels of the type I IFN signaling pathway on whole blood samples
- Serum cytokines levels using multiplex platforms
연구 개요
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
-
-
-
Rotterdam, 네덜란드, 3015 CE
- Erasmus Medical Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients between 18 and 70 years of age, with a chronic hepatitis C - genotype 1b infection
- Patients are non-responders to previous treatment with peginterferon or conventional interferon plus ribavirin combination therapy
- High viral load (>400,000 IU/ml)
- Indication for antiviral therapy of hepatitis C according to current clinical guidelines
- Written informed consent
Exclusion Criteria:
- Decompensated cirrhosis (Child-Pugh Grade B or C)
- Hepatic imaging (ultrasound, CT or MRI) with the evidence of hepatocellular carcinoma within the last 3 months.
- Females who are pregnant or breast-feeding
- History or other evidence of severe illness, malignancy or any other condition which would make the patient, in the opinion of the investigators, unsuitable for the study
- Co-infections with human immunodeficiency virus (HIV) or Hepatitis B virus (HBV)
- Presence of contra-indications for antiviral therapy with ASV and DCV:
- Interfering substance abuse, such as high alcohol intake (indicator: 28 drinks/ week)
- Any exposure to NS3 protease inhibitors or NS5A polymerase inhibitors
- Treatment with peginterferon/ ribavirin within 6 months before start of therapy
- Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating and completing in the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Daclatasvir and asunaprevir
daclatasvir 60 mg once daily asunaprevir 100 mg BID
|
60 mg once daily
100 mg BID
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
HCV-specific T cell phenotype and function (a composite measure of (I) HCV-specific T-cell frequency and (II) phenotypic expression of memory markers and (III) inhibitory receptor markers
기간: 1 year
|
1 year
|
NK cell phenotype and function (a composite measure of (I) NK cell frequency and (II) expression of activation and inhibitory markers (III) IFN-y production upon IL-12/IL-18 stimulation and (IV) Perforin granzyme production
기간: 1 year
|
1 year
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
Gene expression levels of the type I IFN signaling pathway on whole blood samples measured by multiplex
기간: 1 year
|
1 year
|
Gene expression levels of leukocyte populations before, during and after treatment measured by microarray
기간: 2 years
|
2 years
|
Serum cytokines levels using multiplex platforms LUMINEX -100
기간: 1 year
|
1 year
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Rob de Knegt, M.D., Erasmus MC
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- Foundation_LiverR
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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