Evaluation of Sickle Cell Liver Disease
Public ClinicalTrials.gov record NCT01950429. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Background: \- Sickle cell disease changes the shape of red cells. This makes them more likely to break down as they get stuck in small blood vessels. This leads to low red cell count and also damage to small blood vessels that supply many organs. One of the affected organs is the liver. Sickle cell disease and its treatment through blood transfusion can lead to significant liver damage. This disease also can cause the liver to regrow abnormally after damage. This can cause high blood pressure in the liver. Researchers want to know if curing sickle cell disease with a stem cell transplant improves liver damage. Objectives: \- To explore specific factors that improve or worsen sickle cell liver disease after a stem cell transplant. Eligibility: \- Adults ages 18 and older with sickle cell liver disease. Design: * Participation will take approximately 7 days over 2 years. * Visit 1: participants will be screened with medical history and review of current treatment regimen. * Visit 2: participants will return to the clinic for explanation of the study and physical exam. They will also have blood and urine tests, and scans of the liver. * All participants will have a 2-night stay at the clinic. They will have a liver biopsy and a test of liver pressure. They will be sedated and a tube will be inserted in a vein in their neck. * Participants who have a stem cell transplant will have a second biopsy about 24 months later. * Over the 2-year study period, participants will have blood drawn 2-4 times and stool samples collected 2 times.
Study identification
- NCT ID
- NCT01950429
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 42 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 16, 2013 (Actual)
- Primary completion
- Jun 11, 2019 (Actual)
- Completion
- Jun 11, 2019 (Actual)
- Last update posted
- May 16, 2022
2013 – 2019
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01950429, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 16, 2022 · Synced Oct 4, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01950429 live on ClinicalTrials.gov.