A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia
2022년 3월 31일 업데이트: AMAG Pharmaceuticals, Inc.
A Phase III, Open-Label Extension Trial of the Safety and Efficacy of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia
To evaluate the safety and efficacy of ferumoxytol for the episodic treatment of iron deficiency anemia (IDA).
연구 개요
연구 유형
중재적
등록 (실제)
634
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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Daugavpils, 라트비아
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Riga, 라트비아, LV-1002
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Riga, 라트비아, LV-1005
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Riga, 라트비아, LV-1006
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Riga, 라트비아, LV-1010
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Valmiera, 라트비아
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Ventspils, 라트비아, LV-3601
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Ventspils, 라트비아
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Alabama
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Birmingham, Alabama, 미국
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Mobile, Alabama, 미국
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Montgomery, Alabama, 미국, 36106
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Montgomery, Alabama, 미국, 36116
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Arizona
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Phoenix, Arizona, 미국, 85032
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Phoenix, Arizona, 미국, 85015
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Tucson, Arizona, 미국, 85710
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Tucson, Arizona, 미국, 85712
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California
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Anaheim, California, 미국
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Bakersfield, California, 미국
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Buena Park, California, 미국
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Colton, California, 미국
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Los Angeles, California, 미국, 90036
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Los Angeles, California, 미국, 90057
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Los Angeles, California, 미국
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Mission Hills, California, 미국
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Orange, California, 미국
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San Diego, California, 미국, 92103
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San Diego, California, 미국, 92123
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San Diego, California, 미국, 92121
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Colorado
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Pueblo, Colorado, 미국
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Connecticut
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Bristol, Connecticut, 미국
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Groton, Connecticut, 미국
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Florida
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Boynton Beach, Florida, 미국, 33426
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Boynton Beach, Florida, 미국, 33472
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Clearwater, Florida, 미국, 33759
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Clearwater, Florida, 미국, 33756
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Hialeah, Florida, 미국
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Holiday, Florida, 미국
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Inverness, Florida, 미국
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Margate, Florida, 미국
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Miami, Florida, 미국, 33126
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Miami, Florida, 미국, 33143
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Miami, Florida, 미국, 33144
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Miami, Florida, 미국, 33175
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Miami, Florida, 미국, 33135
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Miami Lakes, Florida, 미국
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Naples, Florida, 미국
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Vero Beach, Florida, 미국
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West Palm Beach, Florida, 미국
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Zephyrhills, Florida, 미국
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Georgia
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Atlanta, Georgia, 미국, 30308
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Atlanta, Georgia, 미국, 30342
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Atlanta, Georgia, 미국, 30312
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Decatur, Georgia, 미국
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Dublin, Georgia, 미국
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Sandy Springs, Georgia, 미국
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Stockbridge, Georgia, 미국
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Illinois
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Aurora, Illinois, 미국
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Chicago, Illinois, 미국, 60616
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Skokie, Illinois, 미국, 60076
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Skokie, Illinois, 미국
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Springfield, Illinois, 미국
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Kansas
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Wichita, Kansas, 미국
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Louisiana
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New Orleans, Louisiana, 미국
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Maryland
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Bethesda, Maryland, 미국
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Hollywood, Maryland, 미국
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Michigan
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Bay City, Michigan, 미국, 48706
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Bay City, Michigan, 미국
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Wyoming, Michigan, 미국
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Missouri
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Kansas City, Missouri, 미국
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Nevada
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Las Vegas, Nevada, 미국
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New Jersey
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Lawrenceville, New Jersey, 미국
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Neptune, New Jersey, 미국
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Plainsboro, New Jersey, 미국
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Voorhees, New Jersey, 미국
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New Mexico
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Albuquerque, New Mexico, 미국
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New York
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Brooklyn, New York, 미국
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New York, New York, 미국, 10038
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North Carolina
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Raleigh, North Carolina, 미국
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Winston-Salem, North Carolina, 미국
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Ohio
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Canton, Ohio, 미국
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Carlisle, Ohio, 미국
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Cincinnati, Ohio, 미국, 45224
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Cincinnati, Ohio, 미국, 45242
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Columbus, Ohio, 미국, 43231
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Marion, Ohio, 미국, 43302
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Marion, Ohio, 미국
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Mentor, Ohio, 미국
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Middletown, Ohio, 미국
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Zanesville, Ohio, 미국
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Oklahoma
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Norman, Oklahoma, 미국
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Pennsylvania
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Jenkintown, Pennsylvania, 미국
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Levittown, Pennsylvania, 미국
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South Carolina
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Columbia, South Carolina, 미국
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Greer, South Carolina, 미국
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Myrtle Beach, South Carolina, 미국
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North Charleston, South Carolina, 미국
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South Dakota
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Rapid City, South Dakota, 미국
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Texas
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Arlington, Texas, 미국
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Dallas, Texas, 미국
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Houston, Texas, 미국, 77030
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Houston, Texas, 미국, 77074
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Houston, Texas, 미국
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Laredo, Texas, 미국
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Longview, Texas, 미국
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San Antonio, Texas, 미국, 78205
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San Antonio, Texas, 미국, 78229
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San Antonio, Texas, 미국
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San Antonio, Texas, 미국, 78215
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Utah
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Orem, Utah, 미국
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Virginia
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Chesapeake, Virginia, 미국
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Norfolk, Virginia, 미국
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, 인도
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Secunderabad, Andhra Pradesh, 인도
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Assam
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Guwahati, Assam, 인도
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Karnataka
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Bangalore, Karnataka, 인도, 560002
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Bangalore, Karnataka, 인도, 560054
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Maharashtra
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Aurangabad, Maharashtra, 인도
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Nagpur, Maharashtra, 인도
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Nashik, Maharashtra, 인도
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Pune, Maharashtra, 인도
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Rajasthan
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Jaipur, Rajasthan, 인도
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Tamil Nadu
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Chennai, Tamil Nadu, 인도
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Madurai, Tamil Nadu, 인도
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Uttar Pradesh
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Lucknow, Uttar Pradesh, 인도, 226003
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Lucknow, Uttar Pradesh, 인도
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British Columbia
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Vancouver, British Columbia, 캐나다
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New Brunswick
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Saint John, New Brunswick, 캐나다
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Ontario
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London, Ontario, 캐나다
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Thornhill, Ontario, 캐나다
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Vaughan, Ontario, 캐나다
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Quebec
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Pointe-Claire, Quebec, 캐나다
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Białystok, 폴란드
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Sopot, 폴란드
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Bekescsaba, 헝가리
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Gyula, 헝가리
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Komárom, 헝가리
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Szekszárd, 헝가리
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Vác, 헝가리
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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
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Key Inclusion Criteria include:
- Participants who completed participation in study AMAG-FER-IDA-301 [NCT01114139]
- Female participants of childbearing potential who are sexually active must be on an effective method of birth control and agree to remain on birth control until completion of participation in the study
Key Exclusion Criteria include:
- Experienced a serious adverse event (SAE) related to ferumoxytol in study AMAG-FER-IDA-301
- Female participants who are pregnant, intend to become pregnant, are breastfeeding, or have a positive serum/urine pregnancy test
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: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Ferumoxytol
Participants received ferumoxytol or placebo during AMAG-FER-IDA-301 [NCT01114139].
Participants enrolled in AMAG-FER-IDA-303, a 6-month Extension Study, were evaluated monthly and could receive treatment with ferumoxytol only if they met criteria defined as persistent or recurrent IDA, hemoglobin <11.0 grams per deciliter (g/dL) and transferrin saturation (TSAT) <20% at any evaluation visit, (except study termination visit).
Participants who met criteria began a 5-week treatment period (TP) and received 2 doses of ferumoxytol 510 mg intravenously (IV).
The first IV 510-mg dose was administered on TP Day 1 (Baseline); the second 2-8 (5±3) days after Dose 1.
The first treatment course with ferumoxytol for participants who previously received placebo in AMAG-FER-IDA-301 was considered Course 1; Course 2 included participants who previously received ferumoxytol in AMAG-FER-IDA-301; subsequent treatment courses were serially numbered.
|
IV Ferumoxytol
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mean Change In Hemoglobin From TP Baseline To TP Week 5 Following The First Course Of Ferumoxytol
기간: TP Baseline (Day 1), TP Week 5
|
Mean change in hemoglobin from TP Baseline (Day 1) to TP Week 5 following the first dose of ferumoxytol was calculated as: Hemoglobin Change = Hemoglobin (TP Week 5) - Hemoglobin (TP Baseline) TP Baseline was the most recent value measured on/after the screening or the closest monthly evaluation visit prior to Day 1 dosing of Course 1. Change from Baseline used an imputed value of 0 for missing values at the post-baseline visit. |
TP Baseline (Day 1), TP Week 5
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mean Change In Hemoglobin Following Each Course Of Ferumoxytol From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol After The First Course
기간: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
|
Mean change in hemoglobin from TP Baseline to TP Week 5 following each course of ferumoxytol after the first course was calculated for each participant as: Hemoglobin Change = Hemoglobin (TP Week 5) - Hemoglobin (TP Baseline) The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered. |
TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
|
|
Percentage Of Participants With An Increase In Hemoglobin ≥2.0 g/dL At Any Time From TP Baseline To TP Week 5
기간: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
|
Proportion of participants with an increase in hemoglobin ≥2.0 g/dL at any time from TP Baseline to TP Week 5 following each course of ferumoxytol.
The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1.
The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered.
|
TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
|
|
Percentage Of Participants Who Achieved A Hemoglobin Level ≥12.0 g/dL At Any Time From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol
기간: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
|
Proportion of participants who achieved a hemoglobin level ≥12.0 g/dL at any time from TP Baseline to TP Week 5 following each course of ferumoxytol.
The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1.
The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered.
|
TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
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|
Mean Change In TSAT Following Each Course Of Ferumoxytol From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol
기간: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
|
Mean change in TSAT from TP Baseline to TP Week 5 following each course of ferumoxytol.
|
TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
|
|
Patient-reported Outcome Measure: Mean Change In Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Questionnaire From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol
기간: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
|
The FACIT-Fatigue questionnaire is a 13-item questionnaire designed and validated to specifically assess the presence and impact of treatment on fatigue and related symptoms, such as tiredness, on health-related quality of life in anemic participants with cancer. The questionnaire has 13 items, each measured on a 4-point Likert scale. Scoring ranges from 0 (the most fatigued) to 52 (the least fatigued) points, with higher scores representing better functioning or less fatigue. Mean change in FACIT-Fatigue questionnaire from TP Baseline to TP Week 5 following each course of ferumoxytol was calculated as: FACIT-Fatigue Score Change = FACIT-Fatigue Score (Week 5) - FACIT-Fatigue Score (Baseline). TP Baseline was the most recent value measured on/after the screening or the closest monthly evaluation visit prior to Day 1 dosing in each course. If the TP Week 5 FACIT-Fatigue Score value was missing, the change from TP Baseline was conservatively imputed as zero. |
TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
|
|
Time To Hemoglobin Increase Of ≥2.0 g/dL Or To A Hemoglobin Level Of ≥12.0 g/dL From Baseline
기간: TP Baseline (Day 1) up to TP Week 5 for Courses 1, 2, and 3
|
Days to event was defined as the days from Baseline to the first time the participant met the criteria. Participants without any post-Baseline study visits were not included in this analysis. The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered. |
TP Baseline (Day 1) up to TP Week 5 for Courses 1, 2, and 3
|
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 (실제)
2010년 7월 27일
기본 완료 (실제)
2012년 9월 24일
연구 완료 (실제)
2013년 4월 23일
연구 등록 날짜
최초 제출
2010년 4월 29일
QC 기준을 충족하는 최초 제출
2010년 4월 30일
처음 게시됨 (추정)
2010년 5월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 4월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 3월 31일
마지막으로 확인됨
2022년 3월 1일
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. .