Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04638829 · ClinicalTrials.gov registry record · Phase 4
Safety and Treatment Satisfaction in Adults With Chronic ITP After Switching to Avatrombopag From Eltrombopag or Romiplostim
A Phase 4 study of Immune Thrombocytopenia, sponsored by Sobi.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 20
- Study locations
NCT04638829: Completed Phase 4 study of Immune Thrombocytopenia, sponsored by Sobi.
NCT04638829 is a Phase 4 study of Immune Thrombocytopenia that has completed, run by Sobi. The registered enrollment target is 60 participants, below the 114-participant average among 6 other Immune Thrombocytopenia trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04638829, a Phase 4 study of Immune Thrombocytopenia, has completed, sponsored by Sobi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 20
- Study locations
Study Summary
Evaluate the safety and tolerability of avatrombopag given for 90 days after stopping treatment with eltrombopag or romiplostim.
Primary Outcome
Safety and Tolerability of Avatrombopag given for 90 days after stopping eltrombopag or romiplostim The incidence and severity of adverse events (AEs), serious adverse events (SAE) and adverse events of special interest (AESIs) will be summarized for all enrolled subjects using counts and percentages. Treatment-emergent AEs and SAEs will be summarized overall, by system organ class, and by preferred term. AESIs will be summarized by event type (thromboembolic events and bleeding events). In add
Conditions Studied
Interventions
- DRUG Avatrombopag Oral Tablet
Study Locations (20)
Florida
- Sobi Site 129 - Miami
- Sobi Site 120 - Ocala
- Sobi Site 125 - St. Petersburg
- Sobi Site 118 - Tampa
Illinois
- Sobi Site 126 - Chicago
- Sobi Site 109 - Peoria
North Carolina
- Sobi Site 121 - Chapel Hill
- Sobi Site 116 - Greenville
Pennsylvania
- Sobi Site 127 - Philadelphia
- Sobi Site 102 - York
Arizona
- Sobi Site 110 - Tucson
California
- Sobi Site 119 - Whittier
District of Columbia
- Sobi Site 123 - Washington D.C.
Louisiana
- Sobi Site 124 - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-03-15 |
| Est. Completion | 2024-01-03 |
| Phase | Phase 4 |
What the finished NCT04638829 record still lists
NCT04638829 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 114-participant average among 6 other Immune Thrombocytopenia trials with a reported enrollment target (47% lower).
The record links to 1 condition, with Immune Thrombocytopenia appearing as the primary indexed condition, and to 1 intervention - of which Avatrombopag Oral Tablet is the first listed.
NCT04638829 names 20 study sites across 14 states, led by Florida, Illinois, North Carolina.
Frequently Asked Questions
What is clinical trial NCT04638829 about?
NCT04638829 is a clinical study titled "Safety and Treatment Satisfaction in Adults With Chronic ITP After Switching to Avatrombopag From Eltrombopag or Romiplostim". Evaluate the safety and tolerability of avatrombopag given for 90 days after stopping treatment with eltrombopag or romiplostim.
What is the current status of trial NCT04638829?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2021-03-15. Estimated completion is 2024-01-03.
What conditions does trial NCT04638829 study?
This clinical trial studies the following conditions: Immune Thrombocytopenia.
What interventions are being tested in trial NCT04638829?
The interventions under investigation include: Avatrombopag Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT04638829?
This trial is sponsored by Sobi, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04638829 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Immune Thrombocytopenia
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.
-
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
RECRUITING · Phase 2
-
Cognitive Dysfunction in Chronic and Persistent Immune Thrombocytopenia
RECRUITING
-
Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment
RECRUITING · Phase 3
-
An Open-label Study of Povetacicept in Participants With Autoimmune Cytopenias
ACTIVE NOT RECRUITING · Phase 1
-
Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)
ACTIVE NOT RECRUITING · Phase 3
-
Long-term Study of Romiplostim in Thrombocytopenic Pediatric Patients With Immune Thrombocytopenia (ITP)
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00576069 · 60 participants
Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
- NCT01297400 · 60 participants · Phase 2
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
- NCT01734122 · 60 participants
Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor
- NCT01804634 · 60 participants · Phase 2
Reduced Intensity Haploidentical BMT for High Risk Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI