Registry For Patients Treated With BeneFix In Usual Care Setting In Germany
2018년 9월 28일 업데이트: 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.
연구 개요
상세 설명
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician
연구 유형
관찰
등록 (실제)
80
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Berlin, 독일, 10249
- Vivantes Klinikum im Friedrichshain
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Berlin, 독일, 13353
- Charite Campus Virchow-Klinikum, Padiatrie mit S. Hamatologie und Onkologie
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Blaubeuren, 독일, 89143
- Kinder- und Jugendarzt-Praxis Blaubeuren
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Bonn, 독일, 53127
- Institute of Experimental Haematology and Transfusion Medicine
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Brannenburg, 독일, 83098
- Praxis fur Kinder- und Jugendmedizin, Homoopathie
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Bremen, 독일, 28177
- Klinikum Bremen-Mitte gGmbH, Professor Hess Kinderklinik
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Delmenhorst, 독일, 27753
- Klinikum Delmehorst gGmbH, Padiatrie
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Duesseldorf, 독일, 40225
- Universitaetsklinikum Duesseldorf, Klinik f. Kinder-Onkologie, Haematologie u. Klinische Immunologie
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Duisburg, 독일, 47051
- CRC Coagulation Research Centre GmbH
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Halle, 독일, 06120
- Klinikum der Martin-Luther-Universitaet Halle-Wittenberg
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Hamburg, 독일, 20246
- Universitaetsklinikum Hamburg-Eppendorf
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Hamburg, 독일, 20251
- Universitaetsklinikum Eppendorf
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Heidelberg, 독일, 69123
- SRH Kurpfalzkrankenhaus Heidelberg
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Koeln, 독일, 50677
- Gemeinschaftspraxis fuer Haematologie und Onkologie
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Memmingen, 독일, 87700
- Klinikum Memmingen, Kinderklinik
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Muenchen, 독일, 80337
- Universitaetskinderklinik und Poliklinik im Dr. von Haunerschen
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Tuebingen, 독일, 72076
- Universitaetsklinik fuer Kinder- und Jugendmedizin
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Bayern
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München, Bayern, 독일, 80336
- Sonnengesundheitszentrum
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Niedersachsen
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Hannover, Niedersachsen, 독일, 30159
- Werlhof-Institut für Haemostaseologie GmbH
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Nordrhein-westfalen
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Muenster, Nordrhein-westfalen, 독일, 48143
- Institut für Thrombophilie und Hämostaseologie
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Linz, 오스트리아, 4020
- Allgemeines Krankenhaus Linz, Kinderklinik
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Patients with hemophilia B
설명
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®.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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A
Patients with Hemophilia B
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
기간: Baseline until last visit (up to 8.7 years)
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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.
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Baseline until last visit (up to 8.7 years)
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Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
기간: Baseline until last visit (up to 8.7 years)
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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.
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Baseline until last visit (up to 8.7 years)
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Number of Participants With Factor IX (FIX) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay
기간: Baseline until last visit (up to 8.7 years)
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FIX inhibitor development was defined as measured inhibitor titer of greater than (>) 0.6 Bethesda Units (BU) using the Nijmegen-modified Bethesda assay.
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Baseline until last visit (up to 8.7 years)
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Number of Participants With Adverse Events (AEs) of Special Interest
기간: Baseline until last visit (up to 8.7 years)
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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.
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Baseline until last visit (up to 8.7 years)
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Investigator Assessment of Treatment Tolerability of Participants
기간: End of study visit (any time up to 8.7 years)
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Investigator assessed the tolerability of participants and categorized as very good, good, moderate and poor.
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End of study visit (any time up to 8.7 years)
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Participant Assessment of Treatment Tolerability
기간: End of study visit (any time up to 8.7 years)
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Participants evaluated their treatment (BeneFIX) tolerability and rated it in 4 categories as very good, good, moderate and poor.
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End of study visit (any time up to 8.7 years)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mean Total Number of Bleeding Episodes in Participants
기간: Baseline until last visit (up to 8.7 years)
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Participants documented all bleeding episodes in a diary during the study.
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Baseline until last visit (up to 8.7 years)
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Mean Total Number of Bleeding Episodes Per Year in Participants
기간: Baseline until last visit (up to 8.7 years)
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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.
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Baseline until last visit (up to 8.7 years)
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Number of Participants With Change From Baseline Status in Number of Days Missed From School or Work
기간: Baseline, up to 8.7 years
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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.
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Baseline, up to 8.7 years
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Investigator Assessment of Treatment Efficacy of Participants
기간: End of study visit (any time up to 8.7 years)
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Investigator evaluated the efficacy of BeneFIX in participants and rated it in 4 categories as very good, good, moderate and poor.
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End of study visit (any time up to 8.7 years)
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Investigator Assessment of Treatment Handling of Participants
기간: End of study visit (any time up to 8.7 years)
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Investigator evaluated the handling (administration) of BeneFIX by participants and rated it in 4 categories as very good, good, moderate and poor.
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End of study visit (any time up to 8.7 years)
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Assessment of Treatment Efficacy by the Participants
기간: End of study visit (any time up to 8.7 years)
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Participants evaluated the efficacy of BeneFIX and rated it in 4 categories as very good, good, moderate and poor.
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End of study visit (any time up to 8.7 years)
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Assessment of Treatment Handling by the Participants
기간: End of study visit (any time up to 8.7 years)
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Participants evaluated the handling (administration) of BeneFIX and rated it in 4 categories as very good, good, moderate and poor.
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End of study visit (any time up to 8.7 years)
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Investigator Assessment of Treatment Satisfaction of Participants
기간: Baseline up to 8.7 years
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Investigator evaluated the participant's satisfaction of treatment with BeneFIX and rated it in 4 categories as very satisfied, satisfied, unsatisfied and very unsatisfied.
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Baseline up to 8.7 years
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2008년 1월 1일
기본 완료 (실제)
2016년 10월 1일
연구 완료 (실제)
2016년 10월 1일
연구 등록 날짜
최초 제출
2008년 7월 8일
QC 기준을 충족하는 최초 제출
2008년 7월 11일
처음 게시됨 (추정)
2008년 7월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 10월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 9월 28일
마지막으로 확인됨
2018년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 3090A1-4406
- B1821011 (기타 식별자: Alias Study Number)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .