Real World Study About Anti-viral Regimen Adjustment on Achieving Complete Response in CHB Patients (REACH)
2021年8月4日 更新者：caidachuan、The Second Affiliated Hospital of Chongqing Medical University
Real World Study on the Effect of HBV-DNA High-precision Detection Based Anti-viral Regimen Adjustment on Achieving Complete Virologic Response in Patients With Chronic Hepatitis B.(REACH)
In the treatment of chronic hepatitis B (CHB), viral suppression is closely related to disease progression, and the lower the viral load, the lower the risk of progression to cirrhosis and hepatocellular carcinoma (HCC).
In addition, a considerable number of patients in China are still using non-first-line antiviral therapy, such as adefovir dipivoxil, lamivudine, and telbivudine (ADV/LAM/LdT).
About 25% of patients who received entecavir(ETV) treatment for more than half a year and confirmed that their DNA had turned negative by non-high-precision detection methods still had low viremia (LLV,DNA>20 IU/ml,IU=international unit), and LLV patients were twice as likely to develop HCC as patients with complete viral response.Patients who have received ETV or second-line NA(LAM/ADV/LdT) treatment for more than half a year to 1 year and confirmed HBV-DNA>10IU/ml by high-precision detection method are recommended to adjust the treatment plan in order to reduce the DNA load below 10IU/ml as soon as possible.
It is up to the doctor, in consultation with the patient, to decide whether or not to make the adjustment.
調査の概要
状態
わからない
詳細な説明
In our hospital, about 150 patients are screened for HBV-DNA every day. Therefore, 54 million patients will be tested for HBV-DNA within one year, of which 30% are estimated to be HBV-DNA ≥10 IU. These patients will be informed to the Department of Infectious Diseases of the Second Affiliated Hospital of Chongqing Medical University for follow-up, and will be randomly divided into three groups according to 1:1. Patients in all three groups will be educated about hepatitis B virus infection and antiviral treatment, and the treatment regimen will be adjusted according to whether their HBV DNA is ≥10 IU/ml or not. Patients in group 1: patients with persistant low level HBV DNA (<10 IU/ml). Patients in group 2: HBV-DNA≥10 IU/ml, receiving HBV-related education and being advised by the doctor to change or to add another NA. Patients in group 2: patients with persistant HBV DNA (>10 IU/ml) but refuse to change the regimen. Patients in group 3: patients with persistant HBV DNA (>10 IU/ml) and agree to change the regimen. Educational methods include videos, including an introduction to hepatitis B virus (disease profile, infection, outcome, HBV infection, vertical transmission and other risk factors) for 5 minutes, brochures with relevant information and consultations with physicians and nurses.
All patients with chronic hepatitis B(CHB) receiving ETV or second-line NA(LAM/ADV/LdT) treatment for more than six months to one year will receive HBV-DNA detection, and patients with HBV-DNA≥10 IU/ml will be informed and recommended to adjust the treatment regimen so that the actual prevalence of HBV-DNA load < 10 IU/ml in Chongqing HBV cohort could be obtained . The investigators estimated that 30% of the patients had HBV-DNA≥ 10 IU/ml, so there were about 16,200 patients had HBV-DNA≥ 10 IU/ml among 54,000 patients a year. These patients will be diagnosed with LLV and will undergo a treatment regimen adjustment, with a recommendation to switch to or use a different type of nucleos(t)ide analogue (NA) for anti-viral treatment.
研究の種類
観察的
入学 (予想される)
10000
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Chongqing
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Chongqing、Chongqing、中国、400010
- 募集
- The Second Affiliated Hospital of Chongqing Medical University
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コンタクト：
- DACHUAN CAI, PhD
- 電話番号：862362887039
- メール：597521685@qq.com
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コンタクト：
- PENG HU, PhD
- 電話番号：8613608338064
- メール：hp_cq@163.com
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主任研究者：
- DACHUAN CAI, Professor
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
14年～70年 (子、大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
The research subjects were patients with CHB (chronic hepatitis B) receiving ETV or second-line NA(LAM/ADV/LdT) who were admitted to The Second Affiliated Hospital of Chongqing Medical University and other centers.
説明
Inclusion Criteria:
- any patients treated with ETV\LAM\ADF\LDT\TDF\TAF.【ADV=adefovir dipivoxil, LAM=lamivudine, and LdT=telbivudine , TAF =Tenofovir alafenamide Fumarate, ETV=Entecavir and TDF=Tenofovir disoproxil fumarate 】
Exclusion Criteria:
- with a expected life span <48 weeks
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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patients with persistant low level HBV DNA (<10 IU/ml)
No further intervention(s) to be administered except for monitoring of HBV DNA viraemia
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monitoring the viraemia only
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patients with persistant HBV DNA (>10 IU/ml) but refuse to change the regimen
All patients with CHB receiving ETV or second-line NA(LAM/ADV/LdT) treatment for more than six months to one year will receive HBV-DNA detection, and patients with HBV-DNA≥10 IU/ml will be informed and recommended to adjust the treatment regimen.
If those patients refuse to change the regimen which they are using , No further intervention(s) to be administered except for monitoring of HBV DNA viraemia until those patients change their idea
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if those patients agree, the regimen will be changed.
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patients with persistant HBV DNA (>10 IU/ml) and agree to change the regimen
All patients with CHB receiving ETV or second-line NA(LAM/ADV/LdT) treatment for more than six months to one year will receive HBV-DNA detection, and patients with HBV-DNA≥10 IU/ml will be informed and recommended to adjust the treatment regimen.They will change their regimen according one which they are using.
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Based on ongoing one, regimen will be changed .
The principle for adjusting anti-viral regimen is as follows: 1.
The patients were treated with second-line drugs: changing ADV to ETV/TAF/TDF , changing LAM to TAF/TDF and changing LdT to TAF/TDF; 2. The patients were treated with ETV: adding or switching to TAF/TDF;3.
TAF or ETV is recommended for patients with one or more TDF risk factors, such as > 40 years old, patients with abnormal bone/kidney related indicators or patients with high risk of bone/kidney injuries.【ADV=adefovir
dipivoxil, LAM=lamivudine, and LdT=telbivudine , TAF =Tenofovir alafenamide Fumarate, ETV=Entecavir and TDF=Tenofovir disoproxil fumarate 】
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The proportion of patients who received a complete virologic response (HBV DNA<10IU/ml) at 24 weeks after therapy adjustment.
時間枠：24 weeks
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The proportion of patients who received a complete virologic response (HBV DNA<10IU/ml) at 24 weeks after therapy adjustment.
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24 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The proportion of patients with complete virologic response (HBV DNA<10IU/ml) at 12 weeks, 48 weeks and 96 weeks after therapy adjustment.
時間枠：12 weeks, 48 weeks ,96 weeks
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The proportion of patients with complete virologic response (HBV DNA<10IU/ml) at 12 weeks, 48 weeks and 96 weeks after therapy adjustment.
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12 weeks, 48 weeks ,96 weeks
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he proportion of patients with normal Alanine transaminase（ALT） at baseline and at each follow-up time point
時間枠：baseline,12 weeks,48 weeks,96 weeks
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he proportion of patients with normal Alanine transaminase（ALT ）at baseline and at each follow-up time point
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baseline,12 weeks,48 weeks,96 weeks
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Changes of estimated glomerularfiltrationratee(GFR) compared with baseline at each follow-up time point.
時間枠：baseline,12 weeks,48 weeks,96 weeks
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Changes of estimated glomerularfiltrationratee(GFR) compared with baseline at each follow-up time point.
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baseline,12 weeks,48 weeks,96 weeks
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Changes of serum creatinine(SCr）compared with baseline at each follow-up time point.
時間枠：baseline,12 weeks,48 weeks,96 weeks
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Changes of serum creatinine(SCr) compared with baseline at each follow-up time point.
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baseline,12 weeks,48 weeks,96 weeks
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Changes of bone mass density（BMD) compared with baseline at each follow-up time point.
時間枠：baseline,12 weeks,48 weeks,96 weeks
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Changes of bone mass density (BMD) compared with baseline at each follow-up time point.
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baseline,12 weeks,48 weeks,96 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：DACHUAN CAI, PhD、The Second Affiliated Hospital of Chongqing Medical University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2020年12月1日
一次修了 (予想される)
2022年7月1日
研究の完了 (予想される)
2022年12月31日
試験登録日
最初に提出
2021年1月17日
QC基準を満たした最初の提出物
2021年1月22日
最初の投稿 (実際)
2021年1月26日
学習記録の更新
投稿された最後の更新 (実際)
2021年8月5日
QC基準を満たした最後の更新が送信されました
2021年8月4日
最終確認日
2021年1月1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
- 2020LCYJ009
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。