A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia
A legfontosabb adatok
- Ki végzi
- Takeda
- Hol
- Boston, Charlottesville, Gainesville, Greenville, Peoria és Tucson (Egyesült Államok)Mind a 7 helyszín megnézéseMég 10 másik országban, 48 helyszínen
- Azonosító
- NCT04278924
- EudraCT 2019-004103-12
- JRCT2031220408
- Állapot
- Befejeződött
- Fázis
- 2. fázis
- Résztvevők
- 41 fő vett részt
- Kezdés
- 2020. nov. 9.
- Befejezés
- 2024. ápr. 29.
- A vizsgálat típusa
- Beavatkozással járó, 7 csoportAz egyik csoport placebót (hatóanyag nélküli szert) kap, összehasonlításként.
- A vizsgált kezelések
- Placebo
- TAK-079
- A regiszteradat frissítve
- 2025. június 15.
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 13 feltétel megnézéseKevesebb
Ki vehet részt
- Diagnosed with ITP that has persisted for ≥3 months, diagnosed in accordance to The American Society of Hematology 2011 Evidence-based Practice Guideline for Immune Thrombocytopenia or the International Consensus Report on The Investigation and Management of Primary Immune Thrombocytopenia as locally applicable
- Has a mean platelet count of <30,000/μL (and individually ≤35,000/μL) on at least 2 measurements at least 1 week apart during screening
- Diagnosis of ITP supported by a prior response to an ITP therapy (other than a thrombopoietin receptor agonists [TPO-RA]) that achieved a platelet count of ≥50,000/μL
- If receiving standard background treatment for ITP, treatment should be stable in dose and frequency for at least 4 weeks before dosing; Permitted standard background treatments may include: 1 oral corticosteroid; ±1 immunosuppressant from the following list: azathioprine, danazol, dapsone, cyclosporine, mycophenolate mofetil, mycophenolate sodium; ±1 TPO-RA (romiplostim, eltrombopag, avatrombopag); ±fostamatinib. Corticosteroids, including dexamethasone, must be given as oral, daily or every-other-day therapy as opposed to pulse therapy; The dose of any permitted standard background therapy must be expected to remain stable through the study, unless dose reduction is required because of toxicities
Ki nem vehet részt
- Use of anticoagulants or any drug with antiplatelet effect (such as aspirin) within 3 weeks before screening
- Has a history of any thrombotic or embolic event within 12 months before screening
- Has a history of splenectomy within 3 months before screening
- Use of intravenous immunoglobulin (IVIg), subcutaneous immunoglobulin or anti-D immunoglobulin treatment within 4 weeks of screening, or an expectation that any therapy besides the participant's standard background therapies may be used for treatment of thrombocytopenia (e.g., a rescue therapy) between screening and dosing
- Use of immunosuppressants (such as cyclophosphamide, vincristine) other than permitted oral immunosuppressants within 6 months before first dosing
- Has received a live vaccine within 4 weeks before screening or has any live vaccine planned during the study; 10 Has had an opportunistic infection ≤12 weeks before initial study dosing or is currently undergoing treatment for a chronic opportunistic infection, such as tuberculosis (TB), pneumocystis pneumonia, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria
- Diagnosed with chronic obstructive pulmonary disease (COPD) or asthma, and a prebronchodilatory forced expiratory volume in 1 second (FEV1) <50% of predicted normal
- Has been diagnosed with myelodysplastic syndrome
- Use of rituximab or any monoclonal antibody (mAb) for immunomodulation within 4 months before first dosing. Note: Participants with prior exposure to rituximab must have cluster of differentiation (CD) 19 counts within the normal range at screening
Helyszínek itt: Egyesült Államok
Még 10 másik országban, 48 helyszínen
- Boston Medical CenterBoston, Egyesült ÁllamokNo longer taking part
- Massachusetts General HospitalBoston, Egyesült ÁllamokNo longer taking part
- University of VirginiaCharlottesville, Egyesült ÁllamokNo longer taking part
- University of FloridaGainesville, Egyesült ÁllamokNo longer taking part
- Leo W Jenkins Cancer CenterGreenville, Egyesült ÁllamokNo longer taking part
- Bleeding and Clotting Disorders InstitutePeoria, Egyesült ÁllamokNo longer taking part
- Arizona Clinical Research Center - Hunt - PPDSTucson, Egyesült ÁllamokNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
Primary immune thrombocytopenia (ITP) is a rare disease that results in low levels of platelets - the cells that help blood clot.
A teljes eredeti leírásKevesebb
The main aim of the study is to check for side effects from taking TAK-079 at three different dose levels. Another aim is to learn if TAK-079 can increase the platelet count in people with ITP.
In addition to receiving stable background therapy for ITP, participants will receive an injection of either TAK-079 or a placebo once a week for 2 months. A placebo looks like TAK-079 but will not have any medicine in it. After treatment, all participants will be followed-up for another 2 months.
Then, participants who received TAK-079 will continue to be followed-up for an extra 4 months. Participants who received the placebo and would like to receive TAK-079 may be able to do this in an extension period in the study.
A vizsgálat 7 csoportja
- Part A & B: Double Blind Period: PlaceboPlacebo, összehasonlításként
Participants received TAK-079 placebo-matching injection subcutaneously (SC), once weekly (QW) for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded short follow-up period (SFP) up to Week 16. Participants who opted to receive treatment with TAK-079 were then randomized to receive TAK-079, SC injection, QW for 8 weeks in Open-label Extension (OLE) Period of Part A or Part B. Participants who did not opt to receive treatment with TAK-079 were followed up for another 16 weeks in an unblinded long follow-up period (LFP) up to Week 32.
Kezelés: Placebo
- Part A: Double Blind Period: TAK-079 100 mgA vizsgált kezelés
Participants received TAK-079 100 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants who opted to receive treatment with TAK-079 were then randomized to receive TAK-079, SC injection, QW for 8 weeks in OLE Period of Part A or Part B. Participants who did not opt to receive treatment with TAK-079 were followed up for another 16 weeks in an unblinded LFP up to Week 32.
Kezelés: TAK-079
- Part A: Double Blind Period: TAK-079 300 mgA vizsgált kezelés
Participants received TAK-079 300 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants who opted to receive treatment with TAK-079 were then randomized to receive TAK-079, SC injection, QW for 8 weeks in OLE Period of Part A or Part B. Participants who did not opt to receive treatment with TAK-079 were followed up for another 16 weeks in an unblinded LFP up to Week 32.
Kezelés: TAK-079
- Part B: Double Blind Period: TAK-079 600 mgA vizsgált kezelés
Participants received TAK-079 600 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants who opted to receive treatment with TAK-079 were then randomized to receive TAK-079, SC injection, QW for 8 weeks in OLE Period of Part A or Part B. Participants who did not opt to receive treatment with TAK-079 were followed up for another 16 weeks in an unblinded LFP up to Week 32.
Kezelés: TAK-079
- Part A: Open-label Extension (OLE) Period: TAK-079 100 mgA vizsgált kezelés
Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 100 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.
Kezelés: TAK-079
- Part A: OLE Period: TAK-079 300 mgA vizsgált kezelés
Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 300 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.
Kezelés: TAK-079
- Part B: OLE Period: TAK-079 600 mgA vizsgált kezelés
Participants who received placebo in double-blind Part B and opted to receive treatment with TAK-079 received TAK-079 600 mg, SC injection, QW for 8 weeks in OLE Period of Part B. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.
Kezelés: TAK-079
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- A Phase 2, Randomized, Double-blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Persistent/Chronic Primary Immune Thrombocytopenia
- Publikációk
- A Phase 2 Randomized Trial of Mezagitamab in Primary Immune Thrombocytopenia.The New England journal of medicine, 2026
- A regiszteradat frissítve
- 2025. június 15.