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

Immune Thrombocytopenia Clinical Trial

Official title:

Prospective, Multi-center, Open-label Study Measuring Safety and Treatment Satisfaction in Adult Subjects With Chronic Immune Thrombocytopenia (ITP) After Switching to Avatrombopag From Eltrombopag or Romiplostim

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04638829
• Other study ID #: AVA-ITP-401
• Status: Completed
• Phase: Phase 4
• Start date: March 15, 2021
• Est. completion date: January 3, 2024

Study information

• Verified date: January 2024
• Source: Sobi, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 3, 2024
• Est. primary completion date: January 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 =50×10?/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.

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Drug:
• Avatrombopag Oral Tablet
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

Locations

Country	Name	City	State
United States	Sobi Site 101	Bethesda	Maryland
United States	Sobi Site 121	Chapel Hill	North Carolina
United States	Sobi Site 126	Chicago	Illinois
United States	Sobi Site 128	Cleveland	Ohio
United States	Sobi Site 113	Dallas	Texas
United States	Sobi Site 116	Greenville	North Carolina
United States	Sobi Site 103	Lincoln	Nebraska
United States	Sobi Site 129	Miami	Florida
United States	Sobi Site 124	New Orleans	Louisiana
United States	Sobi Site 120	Ocala	Florida
United States	Sobi Site 109	Peoria	Illinois
United States	Sobi Site 127	Philadelphia	Pennsylvania
United States	Sobi Site 104	Rock Hill	South Carolina
United States	Sobi Site 125	Saint Petersburg	Florida
United States	Sobi Site 108	Salt Lake City	Utah
United States	Sobi Site 118	Tampa	Florida
United States	Sobi Site 110	Tucson	Arizona
United States	Sobi Site 123	Washington	District of Columbia
United States	Sobi Site 119	Whittier	California
United States	Sobi Site 102	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sobi, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Screening through Day 90 or End of Study
Secondary	Subject reported outcomes	Evaluate the change in subject reported outcomes (TSQM questionnaire) from Baseline after switching to avatrombopag from eltrombopag or romiplostim	Screening through Day 90 or End of Study
Secondary	Platelet counts	Evaluate the platelet counts after switching to avatrombopag from eltrombopag or romiplostim	Screening through Day 90 or End of Study