이탈리아 만성 델타 간염(CHD) 환자에 대한 Bulevirtide(BLV) 치료의 효과 및 안전성(D-SHIELD) (D-SHIELD)
이탈리아 만성 델타 간염(CHD) 환자에 대한 Bulevirtide(BLV) 치료의 효과 및 안전성: 다기관 전향적 실제 생활 데이터 연구
Multicenter pharmacological observational prospective, no-profit, study.
This study was designed to get a "real-life" snapshot across several Italian Hepatology centers. All HDV patients are followed up according to EASL 2017 guidelines. This allows uniformity on the indication for antiviral treatment and management of that antiviral therapy. No off-label medications are used. All data are retrievable from the patient's medical record. In addition, clinical and biochemical data from patients at month 0, 1, 2, 4, 6 and 12 of treatment, and otherwise within the study period, will be collected longitudinally.
The primary objective of the study is to describe the virological response to BLV in all patients starting BLV therapy for CHD, defined as a >2 Log decline in HDV-RNA or undetectable HDV-RNA (using the Robogene 2.0 quantitative kit, LLQ <6 IU/ml) at month 12 of therapy.
HDV patients who will start therapy with BLV 2 mg/day from May 2023, according to AIFA guidelines, will be consecutively enrolled.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 장소
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-
MI
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Milan, MI, 이탈리아, 20122
- 모병
- Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.
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연락하다:
- Pietro Lampertico, MD
- 전화번호: 0255035432
- 이메일: pietro.lampertico@unimi.it
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
All patients with CHD (quantifiable HDV-RNA) who will start treatment with BLV 2 mg/day during the study period at the S.C. Gastroenterology and Hepatology (Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico) and at participating centers, and who met the inclusion criteria and none of the exclusion criteria.
설명
Inclusion Criteria:
- 18 years of age or older
- Chronic hepatitis delta
- Compensated cirrhosis HDV related
- Patients who will start therapy with BLV 2 mg/day from May 2023
Exclusion Criteria:
- HDV-related decompensated cirrhosis (CPT ≥7)
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 |
|---|---|
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Hepatis Delta
Bulevirtide (BLV) at a dose of 2 mg/day subcutaneously |
dose of 2 mg/day subcutaneously |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Describe the virological response to BLV in all patients starting BLV therapy for CHD
기간: Month 6
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Percentage of patients with undetectable HDV RNA |
Month 6
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Describe the virological response to BLV in all patients starting BLV therapy for CHD
기간: Month 12
|
Percentage of patients with ≥ 2 log IU/ml decline of HDV RNA |
Month 12
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA
기간: Month 6
|
Proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA |
Month 6
|
|
Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA
기간: Month 12
|
Proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA |
Month 12
|
|
Evaluation of the proportion of patients with virological response, defined as undetectable HDV-RNA
기간: Month 6
|
Proportion of patients with virological response, defined as undetectable HDV-RNA |
Month 6
|
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Evaluation of the proportion of patients with virological response, defined as undetectable HDV-RNA
기간: Month 12
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Proportion of patients with virological response, defined as undetectable HDV-RNA |
Month 12
|
|
Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT
기간: Month 6
|
Percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT |
Month 6
|
|
Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT
기간: Month 12
|
Percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT |
Month 12
|
|
Evaluation of the percentage of patients with normal ALT
기간: Month 6
|
Percentage of patients with normal ALT |
Month 6
|
|
Evaluation of the percentage of patients with normal ALT
기간: Month 12
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Percentage of patients with normal ALT |
Month 12
|
|
Evaluation of the percentage of patients with clinical response, i.e., the percentage of patients who remain free of liver complications, such as HCC or decompensation
기간: Month 6
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Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation) |
Month 6
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Evaluation of the percentage of patients with clinical response, i.e., the percentage of patients who remain free of liver complications, such as HCC or decompensation
기간: Month 12
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Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation) |
Month 12
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|
Investigation of changes over time in serum levels of HBsAg (UI/mL)
기간: Month 6
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Change in serum levels of HBsAg- by medians and ranges |
Month 6
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Investigation of changes over time in serum levels of HBsAg (UI/mL)
기간: Month 12
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Change in serum levels of HBsAg- by medians and ranges |
Month 12
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Investigation of changes over time in serum levels of albumin (g/dL)
기간: Month 6
|
Change in serum levels albumin- by medians and ranges |
Month 6
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Investigation of changes over time in serum levels of albumin (g/dL)
기간: Month 12
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Change in serum levels albumin- by medians and ranges |
Month 12
|
|
Investigation of changes over time in serum levels of platelets (10e9/L)
기간: Month 6
|
Change in serum levels of platelets - by medians and ranges |
Month 6
|
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Investigation of changes over time in serum levels of platelets (10e9/L)
기간: Month 12
|
Change in serum levels of platelets - by medians and ranges |
Month 12
|
|
Investigation of changes over time in serum levels of AFP (µg/L)
기간: Month 6
|
Change in serum levels of AFP - by medians and ranges |
Month 6
|
|
Investigation of changes over time in serum levels of AFP (µg/L)
기간: Month 12
|
Change in serum levels of AFP - by medians and ranges |
Month 12
|
|
Evaluation of treatment safety
기간: Month 6
|
Occurrence of change in serum bile acid levels (µmol/L) |
Month 6
|
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Evaluation of treatment safety
기간: Month 6
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Occurrence of adverse events |
Month 6
|
|
Evaluation of treatment safety
기간: Month 12
|
Occurrence of change in serum bile acid levels (µmol/L) |
Month 12
|
|
Evaluation of treatment safety
기간: Month 12
|
Occurrence of adverse events |
Month 12
|
공동 작업자 및 조사자
스폰서
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (추정된)
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
- 184853
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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