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The Mechanistic Biology of Primary Immunodeficiency Disorders

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 31, 2029 → Dec 31, 2030
Enrollment reduced 52% 2500 → 1190 participants
See other at-risk trials from National Institute of Allergy and Infectious Diseases (NIAID)

Record History

The 50 most recent of 241 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 31, 2029 to Dec 31, 2030 Enrollment reduced: 2500 → 1190 participants Show 1 more changeShow less
    • Enrollment reduced: 2500 → 1190 participants
  2. Enrollment target: 2500 to 1190 Study description shortened, about 30 words · Site details revised at 1 of 2 sites · Eligibility criteria expanded, about 3 words Show 3 more changesShow less
    • Study description shortened, about 30 words
    • Site details revised at 1 of 2 sites
    • Eligibility criteria expanded, about 3 words
  3. Re-verified, no change to tracked fields
  4. Eligibility criteria expanded, about 9 words Site details revised at 1 of 2 sites Show 1 more changeShow less
    • Site details revised at 1 of 2 sites
  5. 15 versions Re-verified since Aug 26, 2025, no change to tracked fieldsv223-v237
Show 31 earlier versionsHide 31 earlier versions
  1. Completion date: Dec 31, 2042 to Dec 31, 2040 Eligibility criteria shortened, about 35 wordsv222 Show 1 more changeShow less
    • Eligibility criteria shortened, about 35 words

    See this version in full on ClinicalTrials.gov ↗

  2. 20 versions Re-verified since Dec 1, 2022, no change to tracked fieldsv202-v221
  3. Study Status, Eligibility, Contacts/Locationsv201
  4. 4 versions Re-verified since Jun 30, 2022, no change to tracked fieldsv197-v200
  5. Enrollment target: 1300 to 2500v196
  6. 4 versions Re-verified since Jun 22, 2022, no change to tracked fieldsv192-v195
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: Primary immunodeficiency disorders, or PIDs, are diseases that weaken the immune system. This makes it easier for a person to get sick. Some PIDs are mild and may not be diagnosed until later in life. Other kinds are severe and can be identified shortly after birth. Researchers want to learn more about PIDs by comparing data from relatives and healthy volunteers to people with a PID. Objective: To learn more about PIDs, including their genetic causes. Eligibility: People ages 0-90 with a PID or their healthy biological relatives the same ages Healthy volunteers ages 18-75 Design: Participants will be screened with a medical history, physical exam, and HIV blood test. They may have a pregnancy test. Participants may repeat the screening tests. Blood taken at screening will be used for genetic tests and research tests. Participants will be told test results that affect their health. Some blood will be stored for future research. Adult participants with a PID may have a small piece of skin removed. The area will be numbed. A small tool will take a piece of skin about the size of a pencil eraser. Researchers may collect fluid or tissue samples from PID participants regular medical care. They will use them for research tests. Participants with a PID will have 3 follow-up visits over 10 years (for infants, 2 years). Visits will include a physical exam, medical history, and blood draw. Participants with a PID and their relatives will be called once a year for 10 years. They will talk about how they are feeling and if they have developed any new symptoms or illnesses. ...
Trial Details
NCT Number NCT03394053
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Primary Immunodeficiency Disorders
Enrollment 1,190 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov