An Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of North Star Desiccated Porcine Thyroid Extract Tablets.
30. juli 2026 opdateret af: Neuvosyn Laboratories, LLC
An Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of North Star Desiccated Porcine Thyroid Extract Tablets for the Treatment of Primary Hypothyroidism
The North Star study is a multi-center, Phase 3, open-label, single-arm clinical study to evaluate the Efficacy and Safety of North Star therapy.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
An Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of North Star Desiccated Porcine Thyroid Extract Tablets for the Treatment of Primary Hypothyroidism
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
466
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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California
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Modesto, California, Forenede Stater, 95355
- Ikke rekrutterer endnu
- Paradigm Clinical Research Centers, LLC
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Kontakt:
- Site Coordinator
- Telefonnummer: 209-554-4844
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Redding, California, Forenede Stater, 96001
- Ikke rekrutterer endnu
- Paradigm Clinical Research Centers, LLC
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Kontakt:
- Site Coordinator
- Telefonnummer: 530-247-7049
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San Diego, California, Forenede Stater, 92108
- Ikke rekrutterer endnu
- Paradigm Clinical Research Centers, LLC
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Kontakt:
- Site Coordinator
- Telefonnummer: 858-274-4226
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Walnut Creek, California, Forenede Stater, 94596
- Ikke rekrutterer endnu
- Sunwise Clinical Research
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Kontakt:
- Site Coordinator
- Telefonnummer: 925-298-5147
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Colorado
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Aurora, Colorado, Forenede Stater, 80012
- Ikke rekrutterer endnu
- Paradigm Clinical Research Centers, LLC
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Kontakt:
- Site Coordinator
- Telefonnummer: 303-219-1830
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Florida
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Lakeland, Florida, Forenede Stater, 33803
- Ikke rekrutterer endnu
- Accel Research
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Kontakt:
- Site Coordinator
- Telefonnummer: 863-940-2087
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Largo, Florida, Forenede Stater, 33777
- Ikke rekrutterer endnu
- Accel Research
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Kontakt:
- Site Coordinator
- Telefonnummer: 727-346-8839
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Miami, Florida, Forenede Stater, 33126
- Rekruttering
- AppleMed Research Group, LLC
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Kontakt:
- Site Coordinator
- Telefonnummer: 305-667-8434
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Miami, Florida, Forenede Stater, 33147
- Rekruttering
- Advanced Medical Research Institute, LLC
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Kontakt:
- Site Coordinator
- Telefonnummer: 786-558-7300
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Miami Lakes, Florida, Forenede Stater, 33014
- Ikke rekrutterer endnu
- 3Sync LLC
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Kontakt:
- Site Coordinator
- Telefonnummer: 786-850-8553
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Palm Springs, Florida, Forenede Stater, 33461
- Ikke rekrutterer endnu
- 3Sync Research
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Kontakt:
- Site Coordinator
- Telefonnummer: 561-910-5792
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Sunrise, Florida, Forenede Stater, 33351
- Ikke rekrutterer endnu
- Precision Clinical Research
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Kontakt:
- Site Coordinator
- Telefonnummer: 954-915-9991
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Idaho
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Boise, Idaho, Forenede Stater, 83709
- Ikke rekrutterer endnu
- Paradigm Clinical Research Centers, LLC
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Kontakt:
- Site Coordinator
- Telefonnummer: 208-801-7438
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02131
- Ikke rekrutterer endnu
- Boston Clinical Trials
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Kontakt:
- Site Coordinator
- Telefonnummer: 617-477-4868
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Methuen, Massachusetts, Forenede Stater, 01844
- Ikke rekrutterer endnu
- ActivMed Practices and Research
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Kontakt:
- Site Coordinator
- Telefonnummer: 978-655-7155
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89106
- Ikke rekrutterer endnu
- M3 Wake Research - Las Vegas Wellness Way
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Kontakt:
- Site Coordinator
- Telefonnummer: 702-893-8968
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North Carolina
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Raleigh, North Carolina, Forenede Stater, 27612
- Ikke rekrutterer endnu
- M3 Wake Research
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Kontakt:
- Site Coordinator
- Telefonnummer: 919-781-2514
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Winston-Salem, North Carolina, Forenede Stater, 27103
- Ikke rekrutterer endnu
- Progressive Medicine of the Triad, LLC
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Kontakt:
- Site Coordinator
- Telefonnummer: 336-768-3456
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29414
- Ikke rekrutterer endnu
- M3 Wake Research
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Kontakt:
- Site Coordinator
- Telefonnummer: 843-258-1852
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North Charleston, South Carolina, Forenede Stater, 29405
- Ikke rekrutterer endnu
- Coastal Carolina Research Center, LLC
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Kontakt:
- Site Coordinator
- Telefonnummer: 7035 843-856-3784
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37421
- Ikke rekrutterer endnu
- M3 Wake Research
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Kontakt:
- Site Coordinator
- Telefonnummer: 423-698-4584
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Texas
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Dallas, Texas, Forenede Stater, 75246
- Ikke rekrutterer endnu
- M3 Wake Research
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Kontakt:
- Site Coordinator
- Telefonnummer: 469-297-3074
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Georgetown, Texas, Forenede Stater, 78628
- Ikke rekrutterer endnu
- Advanced Medical Trials, LLC
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Kontakt:
- Site Coordinator
- Telefonnummer: 306 512-868-0901
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Sugar Land, Texas, Forenede Stater, 77478
- Ikke rekrutterer endnu
- Olympus Clinical Research
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Kontakt:
- Site Coordinator
- Telefonnummer: 346-397-4457
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22911
- Ikke rekrutterer endnu
- Charlotteville Medical Research Center, LLC
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Kontakt:
- Site Coordinator
- Telefonnummer: 434-817-2442
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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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Diagnosed with primary hypothyroidism, including Hashimoto's Thyroiditis, and on therapy with a stable dose of LT4 (minimum 50 mcg per day, administered 7 days per week) for at least 12 weeks prior to Screening
- Have had euthyroid status for at least 6 weeks and up to 12 months prior to Screening (Visit 1), with at least one documented minimum stable dose of 50 mcg LT4.
- Agree to practice a method of contraception
- Female patients not pregnant or lactating at Screening
- Agree to practice a method of contraception of greater than 90% reliability
- Willing to give written informed consent for the Study
- Provide written authorization for use and disclosure of protected health information
Exclusion Criteria:
- Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation or excretion of North Star
- Hospitalization for a major illness within 5 weeks prior to Screening
- Concomitant use of prohibited medications or supplements
- Have uncontrolled diabetes
- Taking or having taken prescription or over-the-counter weight loss medications within 6 weeks prior to Screening
- Participated in another investigational new drug study within 30 days or 5 half-lives of the IMP, whichever is longer, prior to the first study drug administration.
- For female subjects, be pregnant, nursing or planning to become pregnant during the study
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 |
|---|---|
|
Eksperimentel: North Star
North Star Desiccated Porcine Thyroid Extract Tablets
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North Star
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Thyroid-stimulating hormone (TSH) levels within the normal reference range at 24 weeks and at a prior post-baseline visit with no intervening out of range values
Tidsramme: 24 weeks
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24 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Collection and review of adverse events (AEs), serious adverse events (SAEs), suspected unexpected serious adverse reactions, adverse events of special interest, clinical laboratory evaluations, 12-lead ECG, and physical examination.
Tidsramme: 30 weeks
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Safety will be evaluated by tracking the frequency, severity, and relationship of adverse events to the study drug from the first dose through the end of the follow-up period.
The number and percentage of participants experiencing any treatment-emergent adverse event (TEAE) will be summarized by system organ class and preferred term.
In addition, SAEs and TEAEs leading to withdrawal from the study will be summarized.
Observed values and change from Baseline values in vital signs (body temperature, systolic and diastolic blood pressure, pulse, and respiratory rate), ECG parameters for QT interval evaluation, clinical laboratory parameters (hematology, serum chemistry, urinalysis) and physical examinations (to include general al appearance, head, eyes, ears, nose, throat, neck, cardiovascular, lungs, abdominal, extremities, neurologic, skin, lymph nodes, and musculoskeletal system) will be summarized by time point.
All safety analyses will be based on the safety population.
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30 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
30. juni 2026
Primær færdiggørelse (Anslået)
1. november 2027
Studieafslutning (Anslået)
1. december 2027
Datoer for studieregistrering
Først indsendt
17. juli 2026
Først indsendt, der opfyldte QC-kriterier
30. juli 2026
Først opslået (Faktiske)
5. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NorthStar003
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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 .