Chronic Granulomatous Disease Clinical Trial
Official title:
Whole Blood Biospecimen Collection for Subjects With Chronic Granulomatous Disease (CGD)
| NCT number | NCT05915897 |
| Other study ID # | SAN-09687 |
| Secondary ID | |
| Status | Terminated |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 23, 2023 |
| Est. completion date | March 25, 2024 |
| Verified date | April 2024 |
| Source | Sanguine Biosciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The primary study objective is to collect biospecimen samples (e.g., blood) from participants diagnosed with Chronic Granulomatous Disease (CGD). The biospecimens will be used to create a biorepository that can be used to identify disease associated biomarkers and potential targets with immune and multi-omics profiling. The disease sample collection and analysis will be the foundation for an extensive network of biospecimen access and linked datasets for future translational research.
| Status | Terminated |
| Enrollment | 6 |
| Est. completion date | March 25, 2024 |
| Est. primary completion date | March 25, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility | Inclusion Criteria: - The participant is willing and able to provide written informed consent - The participant is willing and able to provide appropriate photo identification - Participants aged 18 to 85 - Participants have been diagnosed with Chronic Granulomatous Disease (CGD) - Subjects who have a confirmed p47phox CGD mutation or Subjects who have a confirmed X-linked CGD mutation Exclusion Criteria: - Participants who are pregnant or are nursing - Participants with a known history of HIV, hepatitis, or other infectious diseases - Participants who have taken an investigational product in the last 30 days - Participants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two months |
| Country | Name | City | State |
|---|---|---|---|
| United States | Sanguine BioSciences, Inc. | Woburn | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Sanguine Biosciences |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Participants have been diagnosed with Chronic Granulomatous Disease (CGD) | Participants have been diagnosed with Chronic Granulomatous Disease (CGD) | 1 Year |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
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