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Идёт набор NCT04867317

Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)

Фаза III С лечением Adult Growth Hormone Deficiency Mild Traumatic Brain Injury

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Somatropin, Placebo.
Кому может быть актуально
Состояния в реестре: Adult Growth Hormone Deficiency, Mild Traumatic Brain Injury. Базовые параметры: 21 лет — 55 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

CSP #2018 - Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)

Обзор

The purpose of this study is to determine whether growth hormone replacement therapy (GHRT) is effective versus placebo in the improvement of Quality of Life in patients with adult growth hormone deficiency (AGHD) and mild traumatic brain injury (mTBI).

Вмешательства

  • Препарат Somatropin
    Participants (n=172) will be randomized in a 1:1 ratio to rhGH (n=86) versus placebo (n=86) for six months, stratified by participating site. Both study participants and the study team will be blinded to treatment assignment. All participants will complete in-clinic follow-ups at Days 14, 40, 65, and 90 (3 months) and at day 180 (6 months). The primary outcome will be the mean difference in QoL-AGHDA scores between treatment arms at 6 months follow-up. Patients will discontinue the study interve
  • Другое Placebo
    Participants (n=172) will be randomized in a 1:1 ratio to rhGH (n=86) versus placebo (n=86) for six months, stratified by participating site. Both study participants and the study team will be blinded to treatment assignment. All participants will complete in-clinic follow-ups at Days 14, 40, 65, and 90 (3 months) and at day 180 (6 months). The primary outcome will be the mean difference in QoL-AGHDA scores between treatment arms at 6 months follow-up. Patients will discontinue the study interve

Первичные конечные точки

  • QoL-AGHDA (Quality of Life-Assessment of Adult Growth Hormone in Adults) [Срок оценки: 6 months]
Вторичные конечные точки (1)
  • Body Composition [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • OEF/OIF/OND Veteran
  • Score of 18 or more on Combat Experiences sub-scale of Deployment Risk and Resilience Inventory-2 (DRRI-2)
  • Age 21 - 55 years old
  • One or more mTBI sustained during military service at least 12 months prior to the screening date, as noted via the CRAFT survey.
  • GH deficiency diagnosed by: macimorelin stimulation test (cut point 5.1 mcg/L), or glucagon stimulation test (cut point: 3 mcg/L for BMI up to 25; cut point 1 mcg/L for BMI 25 and above) and IGF-I lab values have to be less than or equal to +1 SDS at baseline
  • Score of 11 or more on QoL-AGHDA
  • 4-week stability on any psychotropic medications
  • 3-month stability on all other hormone treatments
  • Able and willing to provide informed consent to participate in this study, and complete study protocol.

Критерии исключения

  • History of moderate or severe TBI
  • History of neurologic disorder other than TBI with substantial impact on quality of life
  • History of bipolar disorder, schizophrenia, or other concurrent psychotic disorder
  • Active suicidal ideation (no plan required) as determined by a score of 2 points or more on the Columbia Suicide Severity Rating Scale (C-SSRS) suicidal ideation rating, or overt suicidal behavior in the past 6 months.
  • Contraindication to rhGH therapy
  • Acute medical illness, active infection, cancer or decompensated chronic medical illness
  • Evidence of substance use disorder, -other than mild alcohol or cannabis use disorder-, or urine toxicology evidence of the use of an illicit drug (excluding cannabis), in the past 6 months. Nicotine use is allowed.
  • Score less than or equal to 41 on Trial 2 or Retention Trial of the Test of Memory and Malingering (TOMM).
  • BMI > 40 or body weight > 350 lbs
  • Pituitary anatomy documented by an MRI using a sella protocol within the last 2 years indicating abnormalities consistent with an etiology other than mild-TBI (i.e.; pituitary mass)
  • Women who are pregnant or of child-bearing potential not on contraception
  • Current use of the following: growth hormone, estrogen or estrogen-like dietary supplements, progestin, IGF-I, or chronic glucocorticoid use in supraphysiologic doses
  • Currently enrolled in any other interventional study unless prior approval is provided by the study chairs and the study sponsor (Cooperative Studies Program)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

США · 16 центров
  • Birmingham VA Medical Center, Birmingham, AL — Birmingham
  • Phoenix VA Health Care System, Phoenix, AZ — Phoenix
  • VA San Diego Healthcare System, San Diego, CA — San Diego
  • Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora
  • Washington DC VA Medical Center, Washington, DC — Washington D.C.
  • Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur
  • VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor
  • Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis
  • … и ещё 8 центров

Идентификаторы

NCT: NCT04867317 · 2018

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗