- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00166387
Hemophilia Inhibitor Genetics Study (HIGS)
연구 개요
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Malmo, 스웨덴, SE-205 02
- Malmö University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Severe hemophilia A is defined as a baseline factor VIII level <1%. A history of inhibitor is defined as ever having a Bethesda titer > 1 BU.
Phase I.
Subjects with hemophilia are eligible for Phase I of the study if all of the following apply:
- An informed consent form, approved by the appropriate IRB/IEC, has been administered, signed, and dated.
- The subject has severe hemophilia A.
- The subject has a history of inhibitor or the subject has no history of inhibitor but has at least 100 exposure days to factor VIII products.
- Sufficient documentation exists to identify the subject's maximum lifetime Bethesda titer.
- The subject has a history of inhibitor and has one or more full brothers with severe hemophilia A, with or without an inhibitor, who are eligible for and have agreed to be in the study, and two parents who have agreed to be in the study or the subject does not have a history of inhibitor but has one or more full brothers with severe hemophilia A and a history of inhibitor who are eligible for and have agreed to be in the study, and two parents who have agreed to be in the study.
Subjects without hemophilia are eligible for Phase I of the study if all of the following apply:
- An informed consent form, approved by the appropriate IRB/IEC, has been administered, signed, and dated.
- The subject is the parent (mother or father) of, or the full sibling of, a subject with hemophilia who is eligible for Phase I of the study.
Phase II.
Subjects with hemophilia are eligible for Phase II of the study if all of the following apply:
- An informed consent form, approved by the appropriate IRB/IEC, has been administered, signed, and dated.
- The subject has severe hemophilia A.
- The subject has a history of inhibitor and two parents who have agreed to be in the study.
- Sufficient documentation exists to identify the subject's maximum lifetime Bethesda titer.
Subjects without hemophilia are eligible for Phase II of the study if all of the following apply:
- An informed consent form, approved by the appropriate IRB/IEC, has been administered, signed, and dated.
- The subject is the parent (mother or father) of a subject with hemophilia who is eligible for Phase II of the study.
Exclusion Criteria:
Phase I.
Subjects (with or without hemophilia) are excluded from participation in Phase I if:
- The minimum family group, defined as a pair of full brothers with hemophilia, either concordant (both with) or discordant (one with, one without) for inhibitor, and both of their parents, is not enrolled.
Phase II.
Subjects are excluded from participation in Phase II if:
- The minimum family group, defined as a person with hemophilia and a history of inhibitor and his mother and father, is not enrolled.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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Phase I, II, III
Phase I consists of a brother pair with hemophilia, one or both of whom has a history of inhibitors, and their parents; Phase II consists of a person with hemophilia and an inhibitor, and both his parents; Phase III consists of an unrelated group of people with hemophilia.
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A single blood draw.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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development of inhibitory antibodies to factor VIII
기간: upon development of inhibitor or following at least 100 exposure days to factor VIII
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upon development of inhibitor or following at least 100 exposure days to factor VIII
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공동 작업자 및 조사자
수사관
- 수석 연구원: Erik Berntorp, MD, PhD, Skåne University Hospital
간행물 및 유용한 링크
일반 간행물
- Berntorp E, Astermark J, Donfield SM, Nelson GW, Oldenburg J, Shapiro AD, Dimichele DM, Ewenstein BM, Gomperts ED, Winkler CA; Hemophilia Inhibitor Genetics Study. Haemophilia Inhibitor Genetics Study - evaluation of a model for studies of complex diseases using linkage and association methods. Haemophilia. 2005 Jul;11(4):427-9. doi: 10.1111/j.1365-2516.2005.01119.x. No abstract available.
- Astermark J, Donfield SM, Gomperts ED, Schwarz J, Menius ED, Pavlova A, Oldenburg J, Kessing B, DiMichele DM, Shapiro AD, Winkler CA, Berntorp E; Hemophilia Inhibitor Genetics Study (HIGS) Combined Cohort. The polygenic nature of inhibitors in hemophilia A: results from the Hemophilia Inhibitor Genetics Study (HIGS) Combined Cohort. Blood. 2013 Feb 21;121(8):1446-54. doi: 10.1182/blood-2012-06-434803. Epub 2012 Dec 6.
- Schwarz J, Astermark J, Menius ED, Carrington M, Donfield SM, Gomperts ED, Nelson GW, Oldenburg J, Pavlova A, Shapiro AD, Winkler CA, Berntorp E; Hemophilia Inhibitor Genetics Study Combined Cohort. F8 haplotype and inhibitor risk: results from the Hemophilia Inhibitor Genetics Study (HIGS) Combined Cohort. Haemophilia. 2013 Jan;19(1):113-8. doi: 10.1111/hae.12004. Epub 2012 Sep 7.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
Blood draw에 대한 임상 시험
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University Hospital, Rouen아직 모집하지 않음
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Haydarpasa Numune Training and Research Hospital완전한
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Ischemia Care LLC완전한허혈성 뇌졸중 | 심방세동 | 혈전성 뇌졸중 | 일시적인 허혈 발작 | 심장색전성 뇌졸중 | 뇌저동맥의 뇌졸중 | 일시적인 뇌혈관 사건미국
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Bedford Hospital NHS TrustAnglia Ruskin University알려지지 않은
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Applied Science & Performance Institute완전한