Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04304820 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Early Initiation of Oral Therapy With Cyclosporine and Eltrombopag for Treatment Naive Severe Aplastic Anemia (SAA)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 178 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Notable Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 39 to 80
    • Site details revised
    v178
  2. Notable Results first posted: Jan 9, 2026v177 Show 7 more changesShow less
    • Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 80 to confirmed 39
    • Secondary endpoints revised (6)
    • Site details revised
    • Study arms: 1 to 2
    • Eligibility criteria shortened, about 1 word
  3. Minor Primary completion date changed from estimate of Mar 1, 2026 to Dec 18, 2024
    • Study completion date: May 31, 2028 to Dec 18, 2033
    v176
  4. Minor Re-verified, no change to tracked fieldsv175
  5. Minor Eligibility criteria expanded, about 44 wordsv174
Show 45 earlier versionsHide 45 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv173
  2. Notable Primary completion date: Mar 1, 2025 to Mar 1, 2026v172
  3. Minor 3 versions Re-verified since Dec 20, 2024, no change to tracked fieldsv169-v171
  4. Minor Study Status, Eligibilityv168
  5. Notable Enrollment target: 39 to 80
    • Study description expanded, about 12 words
    v167
  6. Minor 6 versions Re-verified since May 9, 2024, no change to tracked fieldsv161-v166
  7. Notable Primary completion date: Mar 1, 2024 to Mar 1, 2025v160
  8. Minor 9 versions Re-verified since Jan 14, 2023, no change to tracked fieldsv151-v159
  9. Notable Primary completion date: Mar 1, 2023 to Mar 1, 2024
    • Study completion date: May 31, 2027 to May 31, 2028
    v150
  10. Minor 21 versions Re-verified since Jun 7, 2022, no change to tracked fieldsv129-v149
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: Severe aplastic anemia (SAA) is a rare and serious blood disorder. It causes the immune system to turn against bone marrow cells. Standard treatment for SSA is a combination of 3 drugs (Cyclosporine \[CsA\], Eltrombopag \[EPAG\], and horse anti-thymocyte globulin \[h-ATG\]). Researchers want to see if starting people at a lower dose of CsA with EPAG before giving them h-ATG is helpful. Objective: To learn if early initiation of oral therapy with CsA and EPAG is safe and effective in people who have SAA and have not been treated with a course of immunosuppressive therapy and EPAG. Eligibility: People ages 3 and older with SAA Design: Participants will be screened with: * medical history * physical exam * electrocardiogram * blood tests * family history * bone marrow biopsy * current medicines. Participants may be screened remotely via telephone conference. Participants will take a lower oral dose of CsA and EPAG. They will take CsA twice a day for 6 months. They will take EPAG for 6 months. Those who cannot visit the NIH Clinical Center within 72 hours will start taking the drugs at home. They will have weekly telephone calls with NIH staff until they visit the Clinical Center. Participants may get h-ATG at the Clinical Center for 4 days. For this, they will have a central line placed. It is a plastic tube inserted into a neck, chest, or arm vein. Participants will repeat most screening tests throughout the study. Participants will have follow-up visits at the Clinical Center at 3 months, 6 months, and annually for 5 years after the start of the study....
Trial Details
NCT Number NCT04304820
Lead Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)
Severe Aplastic Anemia
Related terms Anemia, Aplastic, Autoimmune Diseases, Thrombocytopenia
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov