Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01623167 · ClinicalTrials.gov registry record · Phase 1
Eltrombopag With Standard Immunosuppression for Severe Aplastic Anemia
A Phase 1 study of Severe Aplastic Anemia, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Active
- Registry status
- Phase 1
- Development phase
- 207
- Enrollment target
- 1
- Study location
NCT01623167 is a Phase 1 study of Severe Aplastic Anemia that is active but no longer recruiting, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 207 participants, above the 114-participant average among 16 other Severe Aplastic Anemia trials with a reported enrollment target (82% higher). The trial reports 1 study location across 1 state.
The verdict
NCT01623167, a Phase 1 study of Severe Aplastic Anemia, is active but no longer recruiting, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 207 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: * Severe aplastic anemia is a rare and serious blood disorder. It happens when the immune system starts to attack the bone marrow cells. This causes the bone marrow to stop making red blood cells, platelets, and white blood cells. Standard treatment for this disease is horse-ATG and cyclosporine, which suppress the immune system and stop it from attacking the bone marrow. However, this treatment does not work in all people. Some people still have poor blood cell counts even after treatment. * Eltrombopag is a drug designed to mimic a protein in the body called thrombopoietin. It helps the body to make more platelets. It may also cause the body to make more red and white blood cells. Studies have shown that eltrombopag may be useful when added to standard treatment for severe aplastic anemia. It may help improve poor blood cell counts. Objectives: \- To test the safety and effectiveness of adding eltrombopag to standard immunosuppressive therapy for severe aplastic anemia. Eligibility: \- Individuals at least 2 years of age who have severe aplastic anemia that has not yet been treated. Design: * Participants will be screened with a physical exam, medical history, and blood tests. Blood and urine samples will be collected. * Participants will start treatment with horse-ATG and cyclosporine. Treatment will be given according to the standard of care for the disease. * Cohort 1: After 14 days, participants will start taking eltrombopag. They will take eltrombopag for up to 6 months. * Cohort 2: After 14 days, participants will start taking eltrombopag. They will take eltrombopag for up to 3 months. * Cohort 3 and Extension Cohort: Participants will start taking eltrombopag on Day 1. They will take eltrombopag for up to 6 months. * Participants may receive other medications to prevent infections during treatment. * Treatment will be monitored with frequent blood tests. Participants will also fill out questionnaires about their symptoms and their quality
Conditions Studied
Interventions
- DRUG Cohort 1: hATG, CsA, EPAG Day 14 to Month 6
- DRUG Cohort 2: hATG, CsA, EPAG Day 14 to Month 3
- DRUG Cohort 3: hATG, CsA (dose reduced), EPAG day 1 to month 6
- DRUG Extension Cohort
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 207 participants |
| Start Date | 2012-07-02 |
| Est. Completion | 2029-11-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01623167
The ClinicalTrials.gov registry entry for NCT01623167 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 207 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 114-participant average among 16 other Severe Aplastic Anemia trials with a reported enrollment target (82% higher). 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 1 condition, with Severe Aplastic Anemia appearing as the primary indexed condition, and to 4 interventions - of which Cohort 1: hATG, CsA, EPAG Day 14 to Month 6 is the first listed.
NCT01623167 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01623167 about?
NCT01623167 is a clinical study titled "Eltrombopag With Standard Immunosuppression for Severe Aplastic Anemia". Background: * Severe aplastic anemia is a rare and serious blood disorder. It happens when the immune system starts to attack the bone marrow cells. This causes the bone marrow to stop making red blood cells, platelets, and white blood cells. Standard treatment for this disease is horse-ATG and cyc...
What is the current status of trial NCT01623167?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 207 participants. The study started on 2012-07-02. Estimated completion is 2029-11-30.
What conditions does trial NCT01623167 study?
This clinical trial studies the following conditions: Severe Aplastic Anemia.
What interventions are being tested in trial NCT01623167?
The interventions under investigation include: Cohort 1: hATG, CsA, EPAG Day 14 to Month 6 (DRUG), Cohort 2: hATG, CsA, EPAG Day 14 to Month 3 (DRUG), Cohort 3: hATG, CsA (dose reduced), EPAG day 1 to month 6 (DRUG), Extension Cohort (DRUG).
Who is sponsoring clinical trial NCT01623167?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01623167 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
Similar trials for Severe Aplastic Anemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Unrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS Using CordIn(TM), Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells to Expedite Engraftment and Improve Transplant Outcome
RECRUITING · Phase 1
-
JAK1/2 Inhibitor Ruxolitinib for Relapsed/Refractory Immune Bone Marrow Failure
RECRUITING · Phase 1
-
CD34+ (Non-Malignant) Stem Cell Selection for Patients Receiving Allogeneic Stem Cell Transplantation
ACTIVE NOT RECRUITING · Phase 1
-
Natural History of Acquired and Inherited Bone Marrow Failure Syndromes
RECRUITING
-
Early Initiation of Oral Therapy With Cyclosporine and Eltrombopag for Treatment Naive Severe Aplastic Anemia (SAA)
RECRUITING · Phase 2
-
Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells
RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.