A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia
31. mars 2022 oppdatert av: 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).
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
634
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
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, Forente stater
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Mobile, Alabama, Forente stater
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Montgomery, Alabama, Forente stater, 36106
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Montgomery, Alabama, Forente stater, 36116
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Arizona
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Phoenix, Arizona, Forente stater, 85032
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Phoenix, Arizona, Forente stater, 85015
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Tucson, Arizona, Forente stater, 85710
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Tucson, Arizona, Forente stater, 85712
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California
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Anaheim, California, Forente stater
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Bakersfield, California, Forente stater
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Buena Park, California, Forente stater
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Colton, California, Forente stater
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Los Angeles, California, Forente stater, 90036
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Los Angeles, California, Forente stater, 90057
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Los Angeles, California, Forente stater
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Mission Hills, California, Forente stater
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Orange, California, Forente stater
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San Diego, California, Forente stater, 92103
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San Diego, California, Forente stater, 92123
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San Diego, California, Forente stater, 92121
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Colorado
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Pueblo, Colorado, Forente stater
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Connecticut
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Bristol, Connecticut, Forente stater
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Groton, Connecticut, Forente stater
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Florida
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Boynton Beach, Florida, Forente stater, 33426
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Boynton Beach, Florida, Forente stater, 33472
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Clearwater, Florida, Forente stater, 33759
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Clearwater, Florida, Forente stater, 33756
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Hialeah, Florida, Forente stater
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Holiday, Florida, Forente stater
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Inverness, Florida, Forente stater
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Margate, Florida, Forente stater
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Miami, Florida, Forente stater, 33126
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Miami, Florida, Forente stater, 33143
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Miami, Florida, Forente stater, 33144
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Miami, Florida, Forente stater, 33175
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Miami, Florida, Forente stater, 33135
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Miami Lakes, Florida, Forente stater
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Naples, Florida, Forente stater
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Vero Beach, Florida, Forente stater
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West Palm Beach, Florida, Forente stater
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Zephyrhills, Florida, Forente stater
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Georgia
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Atlanta, Georgia, Forente stater, 30308
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Atlanta, Georgia, Forente stater, 30342
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Atlanta, Georgia, Forente stater, 30312
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Decatur, Georgia, Forente stater
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Dublin, Georgia, Forente stater
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Sandy Springs, Georgia, Forente stater
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Stockbridge, Georgia, Forente stater
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Illinois
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Aurora, Illinois, Forente stater
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Chicago, Illinois, Forente stater, 60616
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Skokie, Illinois, Forente stater, 60076
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Skokie, Illinois, Forente stater
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Springfield, Illinois, Forente stater
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Kansas
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Wichita, Kansas, Forente stater
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Louisiana
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New Orleans, Louisiana, Forente stater
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Maryland
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Bethesda, Maryland, Forente stater
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Hollywood, Maryland, Forente stater
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Michigan
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Bay City, Michigan, Forente stater, 48706
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Bay City, Michigan, Forente stater
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Wyoming, Michigan, Forente stater
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Missouri
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Kansas City, Missouri, Forente stater
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Nevada
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Las Vegas, Nevada, Forente stater
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New Jersey
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Lawrenceville, New Jersey, Forente stater
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Neptune, New Jersey, Forente stater
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Plainsboro, New Jersey, Forente stater
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Voorhees, New Jersey, Forente stater
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New Mexico
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Albuquerque, New Mexico, Forente stater
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New York
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Brooklyn, New York, Forente stater
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New York, New York, Forente stater, 10038
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North Carolina
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Raleigh, North Carolina, Forente stater
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Winston-Salem, North Carolina, Forente stater
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Ohio
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Canton, Ohio, Forente stater
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Carlisle, Ohio, Forente stater
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Cincinnati, Ohio, Forente stater, 45224
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Cincinnati, Ohio, Forente stater, 45242
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Columbus, Ohio, Forente stater, 43231
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Marion, Ohio, Forente stater, 43302
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Marion, Ohio, Forente stater
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Mentor, Ohio, Forente stater
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Middletown, Ohio, Forente stater
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Zanesville, Ohio, Forente stater
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Oklahoma
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Norman, Oklahoma, Forente stater
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Pennsylvania
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Jenkintown, Pennsylvania, Forente stater
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Levittown, Pennsylvania, Forente stater
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South Carolina
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Columbia, South Carolina, Forente stater
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Greer, South Carolina, Forente stater
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Myrtle Beach, South Carolina, Forente stater
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North Charleston, South Carolina, Forente stater
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South Dakota
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Rapid City, South Dakota, Forente stater
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Texas
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Arlington, Texas, Forente stater
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Dallas, Texas, Forente stater
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Houston, Texas, Forente stater, 77030
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Houston, Texas, Forente stater, 77074
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Houston, Texas, Forente stater
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Laredo, Texas, Forente stater
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Longview, Texas, Forente stater
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San Antonio, Texas, Forente stater, 78205
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San Antonio, Texas, Forente stater, 78229
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San Antonio, Texas, Forente stater
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San Antonio, Texas, Forente stater, 78215
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Utah
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Orem, Utah, Forente stater
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Virginia
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Chesapeake, Virginia, Forente stater
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Norfolk, Virginia, Forente stater
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, India
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Secunderabad, Andhra Pradesh, India
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Assam
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Guwahati, Assam, India
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Karnataka
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Bangalore, Karnataka, India, 560002
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Bangalore, Karnataka, India, 560054
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Maharashtra
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Aurangabad, Maharashtra, India
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Nagpur, Maharashtra, India
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Nashik, Maharashtra, India
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Pune, Maharashtra, India
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Rajasthan
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Jaipur, Rajasthan, India
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Tamil Nadu
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Chennai, Tamil Nadu, India
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Madurai, Tamil Nadu, India
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Uttar Pradesh
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Lucknow, Uttar Pradesh, India, 226003
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Lucknow, Uttar Pradesh, India
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Daugavpils, Latvia
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Riga, Latvia, LV-1002
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Riga, Latvia, LV-1005
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Riga, Latvia, LV-1006
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Riga, Latvia, LV-1010
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Valmiera, Latvia
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Ventspils, Latvia, LV-3601
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Ventspils, Latvia
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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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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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 navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
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
|
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
|
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
27. juli 2010
Primær fullføring (Faktiske)
24. september 2012
Studiet fullført (Faktiske)
23. april 2013
Datoer for studieregistrering
Først innsendt
29. april 2010
Først innsendt som oppfylte QC-kriteriene
30. april 2010
Først lagt ut (Anslag)
3. mai 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. april 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. mars 2022
Sist bekreftet
1. mars 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AMAG-FER-IDA-303
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .