Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects
2011년 4월 1일 업데이트: Wyeth is now a wholly owned subsidiary of Pfizer
An Evaluation Of The Safety And Efficacy Of On-Demand Treatment With BeneFIX (Nonacog Alfa, Recombinant Factor IX) In Chinese Subjects With Hemophilia B
This study will evaluate the safety and efficacy of on-demand treatment with BeneFIX in Chinese hemophilia B subjects.
연구 개요
연구 유형
중재적
등록 (실제)
35
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Beijing, 중국, 100730
- Pfizer Investigational Site
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Shanghai, 중국, 200025
- Pfizer Investigational Site
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Guangzhou
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Guangzhou, Guangzhou, 중국, 510515
- Pfizer Investigational Site
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Jiangsu
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Suzhou, Jiangsu, 중국, 215006
- Pfizer Investigational Site
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Tianjin
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Tianjin, Tianjin, 중국, 300020
- Pfizer Investigational Site
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Zhejiang
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Hangzhou, Zhejiang, 중국, 310003
- Pfizer Investigational Site
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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
6년 이상 (어린이, 성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Subjects equal or more than 6 years of age with mild, moderate or severe hemophilia B (FIX activity: more than 5%, 1-5%, or less than 1%, respectively)
- Subjects with previous exposure to FIX replacement therapy
- If HIV positive, documented CD4 count more than 200/µL within 6 months of study entry
Exclusion Criteria:
- Diagnosed with any bleeding disorder in addition to hemophilia B
- Current FIX inhibitor or history of FIX inhibitor (defined as >ULN of the reporting laboratory)
- Subject has no history of exposure to FIX products (previously untreated patient [PUP])
- Subject is currently utilizing primary FIX prophylaxis
- Subjects anticipating elective surgery that may be planned to occur in the 6 months following study entry
- Treated with immunomodulatory therapy within 30 days prior to study entry or planned use for the duration of their study participation
- Participated in another investigational drug or device study within 30 days prior to study entry or planned participation for the duration of their study participation
- Subjects with a known hypersensitivity to hamster protein
- Significant hepatic or renal impairment (ALT and AST >5 x ULN, bilirubin >2 mg/dL or serum creatinine >1.25 x ULN)
- Prothrombin Time >1.5 x ULN
- Platelet count <80,000/µL
- Pregnant or breastfeeding women
- Unwilling or unable to follow the terms of the protocol
- Any condition which may compromise the subject's ability to comply with and/or perform study-related activities or that poses a clinical contraindication to study participation, in the opinion of the Investigator or Sponsor
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Benefix
Subjects received on-demand treatments with BeneFIX over a 6-month (calendar day) period.
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BeneFIX for on-demand treatment of bleeding episodes were according to investigator prescription.
FIX recovery was assessed by determining the FIX activity (FIX:C) levels in individual subjects.
BeneFIX dosage for recovery assessments: single 75 IU/kg (±5 IU/kg) IV bolus infusion.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Investigator Hemostatic Efficacy Assessment of Participants After 8 Hours Post Infusion
기간: 8 hours post infusion
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Investigator Hemostatic Efficacy Assessment was based on response of bleeding episodes to BeneFIX treatment on 4-point rating scale: Excellent(1): definite pain relief or improvement in signs of bleeding starting within 8 hrs after infusion, with no additional infusion; Good(2): definite pain relief or improvement in signs of bleeding starting within 8 hrs or following infusion; Moderate(3): probable or slight improvement starting after 8 hours following infusion; No Response(4): no improvement at all between infusions or during 24 hour interval following an infusion, or condition worsens.
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8 hours post infusion
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Investigator Hemostatic Efficacy Assessment of Participants After 24 Hours Post Infusion
기간: 24 hours post infusion
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Investigator Hemostatic Efficacy Assessment was based on response of bleeding episodes to BeneFIX treatment on 4-point rating scale: Excellent(1): definite pain relief or improvement in signs of bleeding starting within 8 hrs after infusion, with no additional infusion; Good(2): definite pain relief or improvement in signs of bleeding starting within 8 hrs or following infusion; Moderate(3): probable or slight improvement starting after 8 hours following infusion; No Response(4): no improvement at all between infusions or during 24 hour interval following an infusion, or condition worsens.
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24 hours post infusion
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Percentage of Participants With FIX Inhibitor Development
기간: Baseline up to 6 months
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Incidence of FIX inhibitor was defined as any result determined as positive at local laboratory, and confirmed at central laboratory with Nijmegen assay result >=0.6 Bethesda Unit (BU).
Incidence was stratified by participant exposure history - Minimally Treated Patients (MTPs): those who had received at least one prior FIX infusion, and <= 100 documented Exposure Days (EDs); while Previously Treated Patients (PTPs): those who had received >100 documented prior EDs.
When number of prior EDs for an individual was not known to be at least 100, participants were included in the MTP population.
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Baseline up to 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Infusions Required to Treat Each Bleed
기간: Baseline up to 6 months
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The number of BeneFIX infusions required to treat each bleeding episode were analyzed.
The average frequency of BeneFIX infusions per hemorrhage incidence to treat every hemorrhage was equal to the total number of injections throughout the study divided by total number of hemorrhagic events.
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Baseline up to 6 months
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FIX Incremental Recovery
기간: Baseline (Visit 2) up to 6 months (Visit 4)
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FIX recovery was assessed by evaluating FIX:C after initial exposure and following 6 months of repeated exposures to BeneFIX.
A modified FIX recovery study was performed at Day 1 (Visit 2) and Month 6/Final/Early Termination visits (Visit 4) and when clinically indicated at the applicable on-demand visits.
Blood samples for determination of FIX:C were collected immediately before BeneFIX infusion and at 30 minutes (±5 minutes) after the start of infusion.
Post-infusion blood samples were collected via venipuncture in arm contralateral to arm used for infusion.
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Baseline (Visit 2) up to 6 months (Visit 4)
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Percentage of Participants With Less Than Expected Therapeutic Effect (LETE)
기간: Baseline up to 6 months
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The incidence of LETE for on-demand treatment was defined as no response after each of 2 successive infusions within 24 hours for the same bleeding event in the absence of confounding factors.
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Baseline up to 6 months
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Percentage of Participants With Allergic-Type Allergic Reactions
기간: Baseline up to 6 months
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Hypersensitivity to undesirable (damaging, discomfort-producing and sometimes fatal) reactions produced by the normal immune system.
Hypersensitivity reactions require a pre-sensitized (immune) state of the host.
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Baseline up to 6 months
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Percentage of Participants With Thrombosis
기간: Baseline up to 6 months
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Thrombosis is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system.
When a blood vessel is injured, the body uses platelets and fibrin to form a blood clot to prevent blood loss.
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Baseline up to 6 months
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Percentage of Participants With Red Blood Cell (RBC) Agglutination
기간: Baseline up to 6 months
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RBC Agglutination is the clumping of red blood cells in the presence of an antibody.
The antibody or other molecule bonded multiple particles and joined them, creating a large complex.
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Baseline up to 6 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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
2009년 2월 1일
기본 완료 (실제)
2009년 12월 1일
연구 완료 (실제)
2009년 12월 1일
연구 등록 날짜
최초 제출
2009년 3월 19일
QC 기준을 충족하는 최초 제출
2009년 3월 19일
처음 게시됨 (추정)
2009년 3월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2011년 4월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2011년 4월 1일
마지막으로 확인됨
2011년 4월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 3090A1-3305
- B1821004
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. .