An Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of North Star Desiccated Porcine Thyroid Extract Tablets.

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

• Препарат Desiccated Porcine Thyroid Extract Tablets
  North Star

Первичные конечные точки

• 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 [Срок оценки: 24 weeks]

Вторичные конечные точки (1)

• 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. [Срок оценки: 30 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 25 центров

• Paradigm Clinical Research Centers, LLC — Modesto
• Paradigm Clinical Research Centers, LLC — Redding
• Paradigm Clinical Research Centers, LLC — San Diego
• Sunwise Clinical Research — Walnut Creek
• Paradigm Clinical Research Centers, LLC — Aurora
• Accel Research — Lakeland
• Accel Research — Largo
• AppleMed Research Group, LLC — Miami
• … и ещё 17 центров

Идентификаторы

NCT: NCT07747103 · NorthStar003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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