A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia
31. marts 2022 opdateret af: 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).
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
634
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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British Columbia
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Vancouver, British Columbia, Canada
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New Brunswick
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Saint John, New Brunswick, Canada
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Ontario
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London, Ontario, Canada
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Thornhill, Ontario, Canada
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Vaughan, Ontario, Canada
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Quebec
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Pointe-Claire, Quebec, Canada
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Alabama
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Birmingham, Alabama, Forenede Stater
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Mobile, Alabama, Forenede Stater
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Montgomery, Alabama, Forenede Stater, 36106
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Montgomery, Alabama, Forenede Stater, 36116
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Arizona
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Phoenix, Arizona, Forenede Stater, 85032
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Phoenix, Arizona, Forenede Stater, 85015
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Tucson, Arizona, Forenede Stater, 85710
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Tucson, Arizona, Forenede Stater, 85712
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California
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Anaheim, California, Forenede Stater
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Bakersfield, California, Forenede Stater
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Buena Park, California, Forenede Stater
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Colton, California, Forenede Stater
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Los Angeles, California, Forenede Stater, 90036
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Los Angeles, California, Forenede Stater, 90057
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Los Angeles, California, Forenede Stater
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Mission Hills, California, Forenede Stater
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Orange, California, Forenede Stater
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San Diego, California, Forenede Stater, 92103
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San Diego, California, Forenede Stater, 92123
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San Diego, California, Forenede Stater, 92121
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Colorado
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Pueblo, Colorado, Forenede Stater
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Connecticut
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Bristol, Connecticut, Forenede Stater
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Groton, Connecticut, Forenede Stater
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Florida
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Boynton Beach, Florida, Forenede Stater, 33426
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Boynton Beach, Florida, Forenede Stater, 33472
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Clearwater, Florida, Forenede Stater, 33759
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Clearwater, Florida, Forenede Stater, 33756
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Hialeah, Florida, Forenede Stater
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Holiday, Florida, Forenede Stater
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Inverness, Florida, Forenede Stater
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Margate, Florida, Forenede Stater
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Miami, Florida, Forenede Stater, 33126
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Miami, Florida, Forenede Stater, 33143
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Miami, Florida, Forenede Stater, 33144
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Miami, Florida, Forenede Stater, 33175
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Miami, Florida, Forenede Stater, 33135
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Miami Lakes, Florida, Forenede Stater
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Naples, Florida, Forenede Stater
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Vero Beach, Florida, Forenede Stater
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West Palm Beach, Florida, Forenede Stater
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Zephyrhills, Florida, Forenede Stater
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Georgia
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Atlanta, Georgia, Forenede Stater, 30308
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Atlanta, Georgia, Forenede Stater, 30342
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Atlanta, Georgia, Forenede Stater, 30312
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Decatur, Georgia, Forenede Stater
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Dublin, Georgia, Forenede Stater
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Sandy Springs, Georgia, Forenede Stater
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Stockbridge, Georgia, Forenede Stater
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Illinois
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Aurora, Illinois, Forenede Stater
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Chicago, Illinois, Forenede Stater, 60616
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Skokie, Illinois, Forenede Stater, 60076
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Skokie, Illinois, Forenede Stater
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Springfield, Illinois, Forenede Stater
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Kansas
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Wichita, Kansas, Forenede Stater
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Louisiana
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New Orleans, Louisiana, Forenede Stater
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Maryland
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Bethesda, Maryland, Forenede Stater
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Hollywood, Maryland, Forenede Stater
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Michigan
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Bay City, Michigan, Forenede Stater, 48706
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Bay City, Michigan, Forenede Stater
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Wyoming, Michigan, Forenede Stater
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Missouri
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Kansas City, Missouri, Forenede Stater
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Nevada
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Las Vegas, Nevada, Forenede Stater
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New Jersey
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Lawrenceville, New Jersey, Forenede Stater
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Neptune, New Jersey, Forenede Stater
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Plainsboro, New Jersey, Forenede Stater
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Voorhees, New Jersey, Forenede Stater
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New Mexico
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Albuquerque, New Mexico, Forenede Stater
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New York
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Brooklyn, New York, Forenede Stater
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New York, New York, Forenede Stater, 10038
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North Carolina
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Raleigh, North Carolina, Forenede Stater
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Winston-Salem, North Carolina, Forenede Stater
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Ohio
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Canton, Ohio, Forenede Stater
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Carlisle, Ohio, Forenede Stater
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Cincinnati, Ohio, Forenede Stater, 45224
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Cincinnati, Ohio, Forenede Stater, 45242
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Columbus, Ohio, Forenede Stater, 43231
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Marion, Ohio, Forenede Stater, 43302
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Marion, Ohio, Forenede Stater
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Mentor, Ohio, Forenede Stater
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Middletown, Ohio, Forenede Stater
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Zanesville, Ohio, Forenede Stater
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Oklahoma
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Norman, Oklahoma, Forenede Stater
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Pennsylvania
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Jenkintown, Pennsylvania, Forenede Stater
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Levittown, Pennsylvania, Forenede Stater
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South Carolina
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Columbia, South Carolina, Forenede Stater
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Greer, South Carolina, Forenede Stater
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Myrtle Beach, South Carolina, Forenede Stater
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North Charleston, South Carolina, Forenede Stater
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South Dakota
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Rapid City, South Dakota, Forenede Stater
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Texas
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Arlington, Texas, Forenede Stater
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Dallas, Texas, Forenede Stater
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Houston, Texas, Forenede Stater, 77030
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Houston, Texas, Forenede Stater, 77074
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Houston, Texas, Forenede Stater
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Laredo, Texas, Forenede Stater
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Longview, Texas, Forenede Stater
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San Antonio, Texas, Forenede Stater, 78205
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San Antonio, Texas, Forenede Stater, 78229
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San Antonio, Texas, Forenede Stater
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San Antonio, Texas, Forenede Stater, 78215
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Utah
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Orem, Utah, Forenede Stater
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Virginia
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Chesapeake, Virginia, Forenede Stater
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Norfolk, Virginia, Forenede Stater
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, Indien
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Secunderabad, Andhra Pradesh, Indien
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Assam
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Guwahati, Assam, Indien
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Karnataka
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Bangalore, Karnataka, Indien, 560002
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Bangalore, Karnataka, Indien, 560054
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Maharashtra
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Aurangabad, Maharashtra, Indien
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Nagpur, Maharashtra, Indien
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Nashik, Maharashtra, Indien
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Pune, Maharashtra, Indien
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Rajasthan
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Jaipur, Rajasthan, Indien
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Tamil Nadu
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Chennai, Tamil Nadu, Indien
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Madurai, Tamil Nadu, Indien
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Uttar Pradesh
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Lucknow, Uttar Pradesh, Indien, 226003
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Lucknow, Uttar Pradesh, Indien
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Daugavpils, Letland
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Riga, Letland, LV-1002
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Riga, Letland, LV-1005
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Riga, Letland, LV-1006
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Riga, Letland, LV-1010
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Valmiera, Letland
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Ventspils, Letland, LV-3601
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Ventspils, Letland
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Białystok, Polen
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Sopot, Polen
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Warszawa, Polen
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Wrocław, Polen
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Bekescsaba, Ungarn
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Gyula, Ungarn
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Komárom, Ungarn
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Szekszárd, Ungarn
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Vác, Ungarn
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
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IV Ferumoxytol
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Mean Change In Hemoglobin From TP Baseline To TP Week 5 Following The First Course Of Ferumoxytol
Tidsramme: TP Baseline (Day 1), TP Week 5
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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
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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
Tidsramme: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
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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
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Percentage Of Participants With An Increase In Hemoglobin ≥2.0 g/dL At Any Time From TP Baseline To TP Week 5
Tidsramme: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
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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.
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TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
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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
Tidsramme: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
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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.
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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
Tidsramme: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
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Mean change in TSAT from TP Baseline to TP Week 5 following each course of ferumoxytol.
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TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
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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
Tidsramme: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
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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
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Time To Hemoglobin Increase Of ≥2.0 g/dL Or To A Hemoglobin Level Of ≥12.0 g/dL From Baseline
Tidsramme: TP Baseline (Day 1) up to TP Week 5 for Courses 1, 2, and 3
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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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
27. juli 2010
Primær færdiggørelse (Faktiske)
24. september 2012
Studieafslutning (Faktiske)
23. april 2013
Datoer for studieregistrering
Først indsendt
29. april 2010
Først indsendt, der opfyldte QC-kriterier
30. april 2010
Først opslået (Skøn)
3. maj 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. april 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. marts 2022
Sidst verificeret
1. marts 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AMAG-FER-IDA-303
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .