만성 HBV-HDV 감염 환자의 면역학적 및 바이러스학적 특성 분석: Bulevirtide 치료에 대한 결과 및 반응 (MPR_BD)
만성 HBV-HDV 감염 환자의 면역학적 및 바이러스학적 특성 분석: 질병 결과 및 Bulevirtide 치료에 대한 반응과의 연관성
Pharmacological, single-center, non-profit observational study.
The present study is part of a cooperation project between the SC Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (Milan, Italy), the University of Milan, the University of Parma and Rome Tor Vergata, funded under the call for Research Projects of Significant National Interest - 2022 PNRR Call (Prot. P2022WEXP2).
Hepatitis D virus (HDV) is a defective RNA virus, which requires the presence of hepatitis B virus (HBV) to infect liver cells and propagate. To date, the mechanisms underlying the accelerated disease progression in the natural history of Delta hepatitis are poorly understood, as is the course of the HDV-specific immune response (CD4 and CD8 T cells). As in chronic HBV and HCV infections, the outcome of chronic HDV infection appears to be dictated primarily by the host immune response, which represents a key determinant for virus control or persistence. For HBV/HDV coinfection, the role of T cells has not been well defined, as suitable animal models are lacking and so far few HDV-specific T cell epitopes have been precisely mapped, mainly limited to HLA-B alleles.
The study is divided into two substudies (cross-sectional and longitudinal). The primary objective of the cross-sectional study is to calculate the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection naïve to treatment with Bulevirtide. The primary objective of the longitudinal study is the change in the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection during treatment with Bulevirtide compared to baseline (pre-treatment).
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (실제)
등록
연락처 및 위치
연구 장소
-
-
-
Milan, 이탈리아, 20122
- Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
The study will enroll patients co-infected with HBV-HDV (defined by positivity of HDV RNA for at least 6 months) who meet the inclusion criteria and no exclusion criteria
설명
Inclusion Criteria:
- 18 years of age or older
- Ability to understand and sign the informed consent
- Chronic HDV infection defined by positivity of HBsAg antigen (HBV) and HDV RNA (HBV-HDV co-infection) for at least 6 months at the time of enrollment.
Exclusion Criteria:
- Co-infection with other viruses (HCV, HIV)
- Treatment with immunosuppressive/immunomodulatory drugs
- Other congenital and/or acquired immunodeficiency conditions
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
|
Hepatis Delta naive
Patients with HDV infection naïve to Bulevirtide therapy |
|
|
Hepatis Delta in therapy
Patients with HDV cirrhosis consecutively started on Bulevirtide therapy during the study enrollment period |
dose of 2 mg/day subcutaneously |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Calculate the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection naïve to treatment with Bulevirtide
기간: through study completion, an average of 2 year
|
Prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection naïve to treatment with Bulevirtide |
through study completion, an average of 2 year
|
|
Change in the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection during treatment with Bulevirtide compared to baseline (pre-treatment)
기간: Month 12
|
Prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection after 12 months of treatment with Bulevirtide compared to baseline (pre-therapy) |
Month 12
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Correlate HDV-specific T cell response with stage of liver disease
기간: through study completion, an average of 2 year
|
Correlation of HDV-specific T cell response with stage of liver disease |
through study completion, an average of 2 year
|
|
Analyze the role of new HBV serum biomarkers (HBcrAg, HBV RNA, HBsAg isoforms) in predicting the stage of liver disease
기간: through study completion, an average of 2 year
|
Quantification of new HBV serum biomarkers (HBcrAg, HBV RNA, HBsAg isoforms) and correlation with the stage of liver disease |
through study completion, an average of 2 year
|
|
Correlate the quantification of HDV RNA within exosomes with the stage of liver disease
기간: through study completion, an average of 2 year
|
Correlation between the quantification of HDV RNA within exosomes and the disease phenotype |
through study completion, an average of 2 year
|
|
Investigate the correlation between the genetic heritage of HDV and the stage of liver disease
기간: through study completion, an average of 2 year
|
Correlation between the genetic heritage of HDV and the stage of liver disease |
through study completion, an average of 2 year
|
|
Define the transcriptional and molecular signatures of CD8 T cell dysfunction in patients with chronic HBV/HDV coinfection
기간: through study completion, an average of 2 year
|
Transcriptional and molecular signatures of CD8 T cell dysfunction in patients with chronic HBV/HDV coinfection |
through study completion, an average of 2 year
|
|
Understanding the role of virus mutations in the virus's ability to escape CD8 T cell surveillance
기간: through study completion, an average of 2 year
|
Correlation between HDV mutations and the ability of the virus itself to escape CD8 T cell surveillance |
through study completion, an average of 2 year
|
|
Correlate the prevalence of HDV-specific T cell responses with response to treatment over time
기간: Month 6
|
Correlation between the change in HDV-specific T responses |
Month 6
|
|
Correlate the prevalence of HDV-specific T cell responses with response to treatment over time
기간: Month 18
|
Correlation between the change in HDV-specific T responses |
Month 18
|
|
Correlate the prevalence of HDV-specific T cell responses with response to treatment over time
기간: through study completion, an average of 2 year
|
Correlation between the change in HDV-specific T responses |
through study completion, an average of 2 year
|
|
Analyze the role of new HBV serum biomarkers (HBcrAg, HBV RNA, HBsAg isoforms) in predicting response to treatment with Bulevirtide;
기간: through study completion, an average of 2 year
|
Quantification of new HBV serum biomarkers (HBcrAg, HBV RNA, HBsAg isoforms) and correlation with response to treatment with Bulevirtide |
through study completion, an average of 2 year
|
|
Correlate quantification of HDV RNA within exosomes with response to Bulevirtide treatment
기간: through study completion, an average of 2 year
|
Correlation between the quantification of HDV RNA within exosomes and the response to treatment with Bulevirtide |
through study completion, an average of 2 year
|
|
Investigate the correlation between the genetic heritage of HDV and the response to treatment with Bulevirtide
기간: through study completion, an average of 2 year
|
Correlation between HDV genetic heritage and response to treatment with Bulevirtide |
through study completion, an average of 2 year
|
공동 작업자 및 조사자
스폰서
스폰서
협력자
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- P2022WEXP2
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .