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

Phase 4

Completed

• Conditions: Immune Thrombocytopenia
• Interventions: Drug: Avatrombopag Oral Tablet

• Registration Number: NCT04638829
• Lead Sponsor: Sobi, Inc.

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2020-11-11
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-20
• Study Start: 2021-03-15
• Primary Completion: 2024-01-03
• Study Completion: 2024-01-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Avatrombopag	Avatrombopag Oral Tablet	Avatrombopag 20 mg oral tablet formulation for 90 days

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability (adverse events)	Screening through Day 90 or End of Study	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.

Secondary Outcome Measures

Name	Time	Method
Subject reported outcomes	Screening through Day 90 or End of Study	Evaluate the change in subject reported outcomes (TSQM questionnaire) from Baseline after switching to avatrombopag from eltrombopag or romiplostim
Platelet counts	Screening through Day 90 or End of Study	Evaluate the platelet counts after switching to avatrombopag from eltrombopag or romiplostim

Trial Locations

Locations (20)

Sobi Site 110; 🇺🇸 Tucson, Arizona, United States

Sobi Site 104; 🇺🇸 Rock Hill, South Carolina, United States

Sobi Site 126; 🇺🇸 Chicago, Illinois, United States

Sobi Site 103; 🇺🇸 Lincoln, Nebraska, United States

Sobi Site 127; 🇺🇸 Philadelphia, Pennsylvania, United States

Sobi Site 102; 🇺🇸 York, Pennsylvania, United States

Sobi Site 109; 🇺🇸 Peoria, Illinois, United States

Sobi Site 119; 🇺🇸 Whittier, California, United States

Sobi Site 116; 🇺🇸 Greenville, North Carolina, United States

Sobi Site 128; 🇺🇸 Cleveland, Ohio, United States

Sobi Site 113; 🇺🇸 Dallas, Texas, United States

Sobi Site 120; 🇺🇸 Ocala, Florida, United States

Sobi Site 125; 🇺🇸 Saint Petersburg, Florida, United States

Sobi Site 123; 🇺🇸 Washington, District of Columbia, United States

Sobi Site 129; 🇺🇸 Miami, Florida, United States

Sobi Site 118; 🇺🇸 Tampa, Florida, United States

Sobi Site 124; 🇺🇸 New Orleans, Louisiana, United States

Sobi Site 101; 🇺🇸 Bethesda, Maryland, United States

Sobi Site 121; 🇺🇸 Chapel Hill, North Carolina, United States

Sobi Site 108; 🇺🇸 Salt Lake City, Utah, United States