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NCT01950429 · ClinicalTrials.gov registry record
Evaluation of Sickle Cell Liver Disease
A clinical trial of Sickle Cell Disease, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- 42
- Enrollment target
- 1
- Study location
NCT01950429: Completed study of Sickle Cell Disease, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT01950429 is a study of Sickle Cell Disease that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 42 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01950429, a study of Sickle Cell Disease, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
To assess severity, rule out portal hypertension, judge prognosis and to help in decisions on altering management
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2013-10-16 |
| Est. Completion | 2019-06-11 |
What the finished NCT01950429 record still lists
NCT01950429 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 0 interventions.
NCT01950429 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01950429 about?
NCT01950429 is a clinical study titled "Evaluation of Sickle Cell Liver Disease". 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 cel...
What is the current status of trial NCT01950429?
This trial is currently completed. The enrollment target is 42 participants. The study started on 2013-10-16. Estimated completion is 2019-06-11.
What conditions does trial NCT01950429 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
Who is sponsoring clinical trial NCT01950429?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01950429 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01950429's enrollment target sits among peer trials
42 122nd of 213 higher than 91 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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