慢性HBV-HDV感染症患者の免疫学的およびウイルス学的特徴付け：ブレビルチド治療の転帰と反応 (MPR_BD)
慢性HBV-HDV感染症患者の免疫学的およびウイルス学的特徴付け：疾患転帰およびブレビルチド治療への反応との関連
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).
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (実際)
入学
連絡先と場所
研究場所
-
-
-
Milan、イタリア、20122
- Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
グループ/コホートの数
コホートと介入
グループ/コホートグループ/コホート |
介入・治療介入・治療 |
|---|---|
|
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 |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Calculate the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection naïve to treatment with Bulevirtide
時間枠：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)
時間枠：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
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Correlate HDV-specific T cell response with stage of liver disease
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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;
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
スポンサー
協力者
協力者
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- P2022WEXP2
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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