Effectiveness Of Daclatasvir-Based Regimens In Patients With Chronic Hepatitis C Infection In Europe: Experience From Named Patient Program And From Early Post-Marketing Authorization Period
Using European data from patients included in the Named Patient Program (NPP) and from the early post-marketing authorization period, the present study aims to describe patient characteristics and to describe the effectiveness of Daclatasvir (DCV)-based regimens in Europe. This will be a retrospective cohort study of patients who received treatment with a DCV-based regimen in the following context:
- Patients enrolled within the European NPP in one of the following countries Austria, Denmark, Italy, Sweden, Spain, Switzerland, United Kingdom; or
- In those countries where DCV is commercially available (ie, Sweden, Germany, United Kingdom), patients who received DCV during the early post-marketing authorization period
The results of this study will contribute to a better understanding of effectiveness of DCV-based regimens in a population that differs from population in the clinical trials, and therefore will provide additional valuable information to inform clinical practice.
This study intends to estimate primarily the effectiveness of DCV-based regimens as measured by the sustained virologic response at post treatment follow-up visit week 12 (SVR12). As well as estimate the effectiveness of DCV-based regimens as measured by SVR12 after the end of Hepatitis C virus (HCV).
This study intends also to describe as secondary objectives the characteristics (ie, demographic and clinical characteristics and treatment patterns of patients starting a new DCV-based regimens) of patients receiving DCV as well as the effectiveness of DCV-based regimens as measured by:
- On-treatment virological response at post treatment follow-up visit Week 4; and
- Virological response at the end of treatment (EOT); and
- The sustained viral response at post treatment follow-up visit Week 4 (SVR4) and post treatment follow-up visit Week 24 (SVR24); and
- The occurrence of virological failure (on-treatment and relapse).
An exploratory objective will be to assess the concordance between SVR4 and SVR12 among the overall population treated with DCV.
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Basel、スイス
- Local Institution
-
-
参加基準
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
説明
Inclusion Criteria:
Patients participating in the DCV NPP from 7 European countries (Austria, Denmark, Italy, Sweden, Spain, Switzerland, and UK). The following patients were eligible to participate in the NPP
- The patient have a serious or life-threatening condition that is impacting life expectancy within 12 months.
- There are no comparable or satisfactory alternative treatments options exist for the patient, and/or currently available treatment options have been exhausted.
- The patient was ineligible to participate in a clinical trial, or there was no ongoing clinical trial in the patient´s country of residence to treat his/her HCV-infection.
- In countries where DCV is commercially available at time of study initiation(Sweden, UK, and Germany), patients treated with DCV during the early post-marketing authorization period.
- Patients initiating any DCV-based regimen during the inclusion periods.
- Recorded in one of the HCV data sources used for the study.
Exclusion Criteria:
- Patients included in the DCV Compassionate use program (CUP) (AI444-237 Protocol) open in 6 European countries (Germany, Austria, Sweden, Netherlands, Norway and UK) after Committee for Medicinal Products for Human Use (CHMP) opinion for the DCV CUP in Europe will be excluded since these patients will be analyzed as part of separate datasets.
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
コホートと介入
グループ/コホート |
|---|
|
Patients treated with DCV (NPP)+Sofosbuvir +/- Ribavirin (RBV)
|
|
Patients treated with DCV (NPP) + Simeprevir +/- RBV
|
|
Patients treated with DCV(post-marketing) + Sofosbuvir +/- RBV
|
|
Patients treated with DCV(post-marketing) + Simeprevir +/- RBV
|
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 |
|---|---|---|
|
SVR12
時間枠：Up to 36 months
|
Effectiveness of DCV-based regimens as measured by the SVR12, overall and in specific patient sub-populations
|
Up to 36 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
SVR4
時間枠：Up to 36 months
|
Effectiveness of DCV-based regimens as measured by SVR4
|
Up to 36 months
|
|
SVR24
時間枠：Up to 36 months
|
Effectiveness of DCV-based regimens as measured by SVR24
|
Up to 36 months
|
|
On-treatment Virological response at week 4 assessed by measuring viral load
時間枠：Up to 36 months
|
Up to 36 months
|
|
|
Virological response at the end of treatment (EOT) assessed by measuring viral load
時間枠：Up to 36 months
|
Up to 36 months
|
|
|
The occurrence of virological failure (on-treatment and relapse) assessed by measuring viral load
時間枠：Up to 36 months
|
Virological failure is defined as virologic breakthrough, other on-treatment failure or relapse, where:
|
Up to 36 months
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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
- AI444-319
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。