Phase 4
Completed N=60
Safety and Treatment Satisfaction in Adults With Chronic ITP After Switching to Avatrombopag From Eltrombopag or Romiplostim
Source: ClinicalTrials.gov NCT04638829 ↗Enrolled (actual)
60
Serious AEs
10.0%
Results posted
Jan 2025
Primary outcomePrimary: Safety and Tolerability (Adverse Events) — 35; 6; 1; 15 Participants
◆ Published Evidence
Emerging
7citations · ~7 / year
Safety, efficacy, and treatment satisfaction in adults with ITP who switched to avatrombopag from another TPO-RA.
Summary
Evaluate the safety and tolerability of avatrombopag given for 90 days after stopping treatment with eltrombopag or romiplostim.
Linked Publications
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Safety, efficacy, and treatment satisfaction in adults with ITP who switched to avatrombopag from another TPO-RA.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability (Adverse Events) |
35; 6; 1; 15; 8; 2 | — |
| SECONDARY Change From Baseline TSQM Convenience Domain Score |
13.5 | 0.0001 sig |
| SECONDARY Change From Baseline TSQM Side Effects Domain Score |
8.3 | 0.0093 sig |
| SECONDARY Change From Baseline TSQM Effectiveness Domain Score |
14.4 | 0.0003 sig |
| SECONDARY Change From Baseline TSQM Global Satisfaction Domain Score |
14.2 | <0.0001 sig |
| SECONDARY Proportion of Subjects Who Have a Platelet Count Between ≥50×10^9/L to ≤200×10^9/L |
33 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has been undergoing treatment for primary ITP with eltrombopag or romiplostim for at least 90 days prior to the Screening Visit/Visit 1.
- Subject has had a previous response (at any time) to either eltrombopag or romiplostim, defined as at least 2 platelet counts ≥50×10⁹/L. Subject is willing and able to comply with all aspects of the protocol, including completing the self-administered Treatment Satisfaction Medication Questionnaire (TSQM).
Exclusion Criteria
- Subject is currently receiving chemotherapy or radiation for any form of cancer.
- Subject with conditions that are likely to prevent them from accurately and reliably completing study assessments, including evidence of moderate to severe dementia, and/or severe and progressive medical illness, as determined by the Investigator.
- Any previous avatrombopag use.
- Previous participation in this study; a subject may not re-enroll after prior discontinuation or completion.
- Enrollment in another clinical study with any investigational drug or device within 30 days of Baseline (or 5 half-lives, whichever is longer); however, participation in observational studies within the previous 30 days is permitted.
Data sourced from ClinicalTrials.gov (NCT04638829) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.