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NCT01375608 · ClinicalTrials.gov registry record · Phase 2
Decitabine for High-Risk Sickle Cell Disease
A Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT01375608 is a Phase 2 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 10 participants.
The verdict
NCT01375608, a Phase 2 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
Background: * In sickle cell disease (SCD), the proteins in the red blood cells that carry oxygen do not behave normally. In parts of the body where there are low levels of oxygen or where oxygen is used more, the sickle hemoglobin proteins may change shape and stick together. This causes the red cells to clump, which reduces blood flow. This leads to even lower oxygen levels and causes damage and/or pain. * One way to stop the red blood cells from sticking together is to increase the levels of fetal (baby or good ) hemoglobin. The good hemoglobin then takes the place of the sickle hemoglobin. * Hydroxyurea is the only approved drug for SCD. But hydroxyurea works in only about two-thirds of people with SCD. Even in those cases it sometimes stops working over time. * Researchers are interested in testing decitabine. The drug may help to increase fetal hemoglobin levels. But it has not yet been approved to treat SCD. Objectives: \- To test the safety and effectiveness of decitabine in increasing fetal hemoglobin levels and improving the symptoms of sickle cell disease. Eligibility: \- People at least 18 years of age who have sickle cell disease that has not improved after at least 6 months of hydroxyurea therapy. Those who cannot take hydroxyurea because of side effects may also participate. Design: * Participants will be screened with a physical exam and medical history. They will also have blood and urine tests, a lung function test, and other tests as required. * Participants will receive decitabine injections up to twice a week for 1 year. Depending on the response to treatments, the dose will remain the same or be reduced to once a week. * Participants will be monitored with frequent blood tests and other studies as directed by the study doctors. * After the study is completed, participants will go back to their usual sickle cell care. If decitabine has improved a participant's SCD, treatment may be continued under regular health coverage insurance if this
Interventions
- DRUG Decitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2011-06 |
| Est. Completion | 2016-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01375608
The ClinicalTrials.gov registry entry for NCT01375608 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Decitabine is the first listed.
NCT01375608 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01375608 about?
NCT01375608 is a clinical study titled "Decitabine for High-Risk Sickle Cell Disease". Background: * In sickle cell disease (SCD), the proteins in the red blood cells that carry oxygen do not behave normally. In parts of the body where there are low levels of oxygen or where oxygen is used more, the sickle hemoglobin proteins may change shape and stick together. This causes the red c...
What is the current status of trial NCT01375608?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2011-06. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01375608?
The interventions under investigation include: Decitabine (DRUG).
Who is sponsoring clinical trial NCT01375608?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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