- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00422838
Study Investigating Immunological Effects of Treatment for Chronic Hepatitis C Patients. (CIRES)
Impact of Immune Responses in Chronic Hepatitis C Genotype 1,2,3 Virus Infected Patients During Treatment With Pegylated Interferon-alpha-2b and Ribavirin (CIRES).
Aim
To evaluate the effects of peginterferon and ribavirin therapy on the immune response in chronic HCV genotype 1,2 or 3 patients before, during and after treatment.
Background
Treatment of chronic hepatitis C (HCV) has shown a remarkable success. However, genotype 1 patients have reduced response rates. A better understanding and improvement of these results can now be considered the greatest challenge.
In chronically infected patients, HCV-specific immune responses are generally weak, narrowly focused, and often dysfunctional. The presence of HCV-specific cells suppressing the immune response (regulatory T-lymphocytes=Treg) are able to suppress the immune response. These Treg are possibly responsible for the impaired immune response.
Previous studies have indicated increased Treg frequency and activity of immune regulating mechanisms, locally in the liver, as a result of HCV re-infection. Hence, these Data highlight the importance of monitoring intrahepatic immune responses in addition to peripheral immune responses. Using the minimally-invasive technique of fine-needle aspiration biopsy (FNAB), it is now possible to obtain safe and frequent liver samples to monitor local antiviral immune responses in chronic HCV patients during antiviral therapy.
Rationale and hypothesis of the study
Our previous studies and current literature support the concept that Treg may contribute to HCV persistence by suppressing HCV-spec immune responses. The current study is designed to examine if peginterferon and ribavirin therapy affects the activity of Treg and DC, and if this results in enhanced HCV-specific immune responses.
Design
Single centre, translational and observational open label study with one arm of 20 genotype 1 patients and one arm of 7 genotype 2/3 patients.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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-
Zuid-Holland
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Rotterdam, Zuid-Holland, 네덜란드, 3015 GD
- Department of Gastroenterology & Hepatology, Erasmus Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Male and female patients between 18-70 years of age, with evidence of a chronic hepatitis C - Genotype 1,2 or 3 infection.
- No previous treatment with, peginterferon or conventional interferon plus ribavirin combination therapy.
- Indication for antiviral therapy of hepatitis C according to current clinical guidelines.
- Written informed consent.
Exclusion Criteria:
- 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.
- Presence of contra-indications for antiviral therapy with peginterferon or ribavirin.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
1
Chronic HCV Genotype 1 monoinfection, never had interferon and ribavirin treatment
|
aspiration of intrahepatic cells
|
2
Chronic HCV Genotype 2 or 3 monoinfection,never had interferon and ribavirin treatment
|
aspiration of intrahepatic cells
|
공동 작업자 및 조사자
수사관
- 수석 연구원: R.J. de Knegt, MD, PhD, Department of Gastroenterology & Hepatology - Erasmus Medical Center Rotterdam
- 수석 연구원: H.L.A. Janssen, MD, PhD, Department of Gastroenterology & Hepatology - Erasmus Medical Center Rotterdam
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- CIRES
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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