Registry For Patients Treated With BeneFix In Usual Care Setting In Germany
2018年9月28日 更新者：Pfizer
Pharmacovigilance Evaluation Of Benefix (Registered) In Germany And Austria
The purpose of this observational study is to describe the incidence of adverse events among patients treated with BeneFix® in usual health care settings in Germany.
調査の概要
詳細な説明
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician
研究の種類
観察的
入学 (実際)
80
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
-
-
-
Linz、オーストリア、4020
- Allgemeines Krankenhaus Linz, Kinderklinik
-
-
-
-
-
Berlin、ドイツ、10249
- Vivantes Klinikum im Friedrichshain
-
Berlin、ドイツ、13353
- Charite Campus Virchow-Klinikum, Padiatrie mit S. Hamatologie und Onkologie
-
Blaubeuren、ドイツ、89143
- Kinder- und Jugendarzt-Praxis Blaubeuren
-
Bonn、ドイツ、53127
- Institute of Experimental Haematology and Transfusion Medicine
-
Brannenburg、ドイツ、83098
- Praxis fur Kinder- und Jugendmedizin, Homoopathie
-
Bremen、ドイツ、28177
- Klinikum Bremen-Mitte gGmbH, Professor Hess Kinderklinik
-
Delmenhorst、ドイツ、27753
- Klinikum Delmehorst gGmbH, Padiatrie
-
Duesseldorf、ドイツ、40225
- Universitaetsklinikum Duesseldorf, Klinik f. Kinder-Onkologie, Haematologie u. Klinische Immunologie
-
Duisburg、ドイツ、47051
- CRC Coagulation Research Centre GmbH
-
Halle、ドイツ、06120
- Klinikum der Martin-Luther-Universitaet Halle-Wittenberg
-
Hamburg、ドイツ、20246
- Universitaetsklinikum Hamburg-Eppendorf
-
Hamburg、ドイツ、20251
- Universitaetsklinikum Eppendorf
-
Heidelberg、ドイツ、69123
- SRH Kurpfalzkrankenhaus Heidelberg
-
Koeln、ドイツ、50677
- Gemeinschaftspraxis fuer Haematologie und Onkologie
-
Memmingen、ドイツ、87700
- Klinikum Memmingen, Kinderklinik
-
Muenchen、ドイツ、80337
- Universitaetskinderklinik und Poliklinik im Dr. von Haunerschen
-
Tuebingen、ドイツ、72076
- Universitaetsklinik fuer Kinder- und Jugendmedizin
-
-
Bayern
-
München、Bayern、ドイツ、80336
- Sonnengesundheitszentrum
-
-
Niedersachsen
-
Hannover、Niedersachsen、ドイツ、30159
- Werlhof-Institut für Haemostaseologie GmbH
-
-
Nordrhein-westfalen
-
Muenster、Nordrhein-westfalen、ドイツ、48143
- Institut für Thrombophilie und Hämostaseologie
-
-
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
- 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
Patients with hemophilia B
説明
Inclusion Criteria:
- Patients with hemophilia B already receiving or starting treatment with reformulated BeneFIX®.
Exclusion Criteria:
- Patients with hemophilia B treated with a product other than BeneFIX®.
- Inclusion in the ongoing prospective registry of European hemophilia B patients using BeneFIX®.
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 |
|---|---|
|
A
Patients with Hemophilia B
|
Patients will be treated in accordance with the requirements of the labeling of BeneFIX in Germany.
The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
|
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 |
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
時間枠：Baseline until last visit (up to 8.7 years)
|
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship.
SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; cancer; congenital anomaly.
Treatment-emergent are events between first dose of study drug and up to last visit (up to 8.7 years) that were absent before treatment or that worsened relative to pretreatment state.
AEs included both serious and non-serious.
|
Baseline until last visit (up to 8.7 years)
|
|
Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
時間枠：Baseline until last visit (up to 8.7 years)
|
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.
SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; cancer; congenital anomaly.
AEs included both serious and non-serious.
Relatedness to BeneFIX was assessed by the investigator.
|
Baseline until last visit (up to 8.7 years)
|
|
Number of Participants With Factor IX (FIX) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay
時間枠：Baseline until last visit (up to 8.7 years)
|
FIX inhibitor development was defined as measured inhibitor titer of greater than (>) 0.6 Bethesda Units (BU) using the Nijmegen-modified Bethesda assay.
|
Baseline until last visit (up to 8.7 years)
|
|
Number of Participants With Adverse Events (AEs) of Special Interest
時間枠：Baseline until last visit (up to 8.7 years)
|
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship.
Adverse Events of special interest included allergic reactions, less than expected therapeutic effect (LETE) of drug, lack of efficacy/low recovery, erythrocyte agglutination in tube or syringe red blood cell (RBC) agglutination phenomena and thrombogenicity.
|
Baseline until last visit (up to 8.7 years)
|
|
Investigator Assessment of Treatment Tolerability of Participants
時間枠：End of study visit (any time up to 8.7 years)
|
Investigator assessed the tolerability of participants and categorized as very good, good, moderate and poor.
|
End of study visit (any time up to 8.7 years)
|
|
Participant Assessment of Treatment Tolerability
時間枠：End of study visit (any time up to 8.7 years)
|
Participants evaluated their treatment (BeneFIX) tolerability and rated it in 4 categories as very good, good, moderate and poor.
|
End of study visit (any time up to 8.7 years)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Total Number of Bleeding Episodes in Participants
時間枠：Baseline until last visit (up to 8.7 years)
|
Participants documented all bleeding episodes in a diary during the study.
|
Baseline until last visit (up to 8.7 years)
|
|
Mean Total Number of Bleeding Episodes Per Year in Participants
時間枠：Baseline until last visit (up to 8.7 years)
|
Participants documented all bleeding episodes in a diary during the study.
Mean total number of bleeding episodes per year was calculated by mean total number of bleeding episodes divided by duration of observation period (in years) for bleeding documentation.
|
Baseline until last visit (up to 8.7 years)
|
|
Number of Participants With Change From Baseline Status in Number of Days Missed From School or Work
時間枠：Baseline, up to 8.7 years
|
Change from baseline status in days missed from school or work was categorized in 3 categories: Improvement, unchanged and worsening.
Improvement was defined as a decrease in number of days missed by participants from school/work as compared to baseline; worsening was defined as an increase in number of days missed by participants from school/work as compared to baseline; unchanged was defined as no change in number of days missed by participants from school/work as compared to baseline.
In this outcome measure, number of participants with change from baseline status (as improved, worsen, unchanged) in days missed from school/work were reported.
|
Baseline, up to 8.7 years
|
|
Investigator Assessment of Treatment Efficacy of Participants
時間枠：End of study visit (any time up to 8.7 years)
|
Investigator evaluated the efficacy of BeneFIX in participants and rated it in 4 categories as very good, good, moderate and poor.
|
End of study visit (any time up to 8.7 years)
|
|
Investigator Assessment of Treatment Handling of Participants
時間枠：End of study visit (any time up to 8.7 years)
|
Investigator evaluated the handling (administration) of BeneFIX by participants and rated it in 4 categories as very good, good, moderate and poor.
|
End of study visit (any time up to 8.7 years)
|
|
Assessment of Treatment Efficacy by the Participants
時間枠：End of study visit (any time up to 8.7 years)
|
Participants evaluated the efficacy of BeneFIX and rated it in 4 categories as very good, good, moderate and poor.
|
End of study visit (any time up to 8.7 years)
|
|
Assessment of Treatment Handling by the Participants
時間枠：End of study visit (any time up to 8.7 years)
|
Participants evaluated the handling (administration) of BeneFIX and rated it in 4 categories as very good, good, moderate and poor.
|
End of study visit (any time up to 8.7 years)
|
|
Investigator Assessment of Treatment Satisfaction of Participants
時間枠：Baseline up to 8.7 years
|
Investigator evaluated the participant's satisfaction of treatment with BeneFIX and rated it in 4 categories as very satisfied, satisfied, unsatisfied and very unsatisfied.
|
Baseline up to 8.7 years
|
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。
スポンサー
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。
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)
2008年1月1日
一次修了 (実際)
2016年10月1日
研究の完了 (実際)
2016年10月1日
試験登録日
最初に提出
2008年7月8日
QC基準を満たした最初の提出物
2008年7月11日
最初の投稿 (見積もり)
2008年7月14日
学習記録の更新
投稿された最後の更新 (実際)
2018年10月25日
QC基準を満たした最後の更新が送信されました
2018年9月28日
最終確認日
2018年9月1日
詳しくは
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。