Safety and Treatment Satisfaction in Adults With Chronic ITP After Switching to Avatrombopag From Eltrombopag or Romiplostim

Sobi, Inc.60 enrolled

Overview

Evaluate the safety and tolerability of avatrombopag given for 90 days after stopping treatment with eltrombopag or romiplostim.

This Phase 4, prospective, multi-center, open-label study will evaluate safety, platelet count, and subject reported medication satisfaction in adult subjects with chronic ITP after switching to avatrombopag from eltrombopag or romiplostim. At least 100 subjects will be enrolled, 50 (±10) who have received eltrombopag and 50 (±10) who have received romiplostim for at least 90 days prior to study entry.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Immune Thrombocytopenia

Interventions

Avatrombopag Oral TabletDRUG

Avatrombopag 20 mg given daily for 90 days. Initial dose and dose adjustments will be determined by the physician along with the Doptelet prescribing information

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (20)

Sobi Site 110

Tucson, Arizona, United States

Sobi Site 119

Whittier, California, United States

Outcomes

Primary Outcomes

Safety and Tolerability (Adverse Events)

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 addition, treatment-emergent AEs will be summarized by severity and by relationship to study drug. Bleeding events reported during the study will be summarized by WHO grade.

Time frame: Screening through Day 90 or End of Study

Secondary Outcomes

Change From Baseline TSQM Convenience Domain Score

Evaluate the change in subject reported outcomes (TSQM - Treatment Satisfaction Questionnaire for Medication) from Baseline. Convenience domain score ranges from 0 to 100, and a higher score indicates a better outcome. Mean Difference was computed as Day 90 minus Baseline and, therefore, a positive mean difference indicates an increase in the score from Baseline to Day 90.

Time frame: Day 90

Change From Baseline TSQM Side Effects Domain Score

Evaluate the change in subject reported outcomes (TSQM - Treatment Satisfaction Questionnaire for Medication) from Baseline. Side Effects domain score ranges from 0 to 100, and a higher score indicates a better outcome. Mean Difference was computed as Day 90 minus Baseline and, therefore, a positive mean difference indicates an increase in the score from Baseline to Day 90.

Time frame: Day 90

Change From Baseline TSQM Effectiveness Domain Score

Evaluate the change in subject reported outcomes (TSQM - Treatment Satisfaction Questionnaire for Medication) from Baseline. Effectiveness domain score ranges from 0 to 100, and a higher score indicates a better outcome. Mean Difference was computed as Day 90 minus Baseline and, therefore, a positive mean difference indicates an increase in the score from Baseline to Day 90.

Data from ClinicalTrials.gov

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