Clinical trial NCT04638829: Safety and Treatment Satisfaction in Adults With Chronic ITP After Switching to Avatrombopag From Eltrombopag or Romiplostim
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Immune Thrombocytopenia
Keywords: ITP
Lead sponsor: Sobi, Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Safety and Tolerability (Adverse Events)
timeFrame: Screening through Day 90 or End of Study
Secondary outcomes:
measure: Change From Baseline TSQM Convenience Domain Score
timeFrame: Day 90
measure: Change From Baseline TSQM Side Effects Domain Score
timeFrame: Day 90
measure: Change From Baseline TSQM Effectiveness Domain Score
timeFrame: Day 90
measure: Change From Baseline TSQM Global Satisfaction Domain Score
timeFrame: Day 90
measure: Proportion of Subjects Who Have a Platelet Count Between ≥50×10^9/L to ≤200×10^9/L
timeFrame: Day 15
measure: Proportion of Subjects Who Have a Platelet Count Between ≥50×10^9/L to ≤200×10^9/L
timeFrame: Day 30
measure: Proportion of Subjects Who Have a Platelet Count Between ≥50×10^9/L to ≤200×10^9/L
timeFrame: Day 60
measure: Proportion of Subjects Who Have a Platelet Count Between ≥50×10^9/L to ≤200×10^9/L
timeFrame: Day 90
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Sobi Site 110
state: Arizona
city: Whittier
country: United States
facility: Sobi Site 119
state: California
city: Washington
country: United States
facility: Sobi Site 123
state: District of Columbia
city: Miami
country: United States
facility: Sobi Site 129
state: Florida
city: Ocala
country: United States
facility: Sobi Site 120
state: Florida
city: Saint Petersburg
country: United States
facility: Sobi Site 125
state: Florida
city: Tampa
country: United States
facility: Sobi Site 118
state: Florida
city: Chicago
country: United States
facility: Sobi Site 126
state: Illinois
city: Peoria
country: United States
facility: Sobi Site 109
state: Illinois
city: New Orleans
country: United States
facility: Sobi Site 124
state: Louisiana
city: Bethesda
country: United States
facility: Sobi Site 101
state: Maryland
city: Lincoln
country: United States
facility: Sobi Site 103
state: Nebraska
city: Chapel Hill
country: United States
facility: Sobi Site 121
state: North Carolina
city: Greenville
country: United States
facility: Sobi Site 116
state: North Carolina
city: Cleveland
country: United States
facility: Sobi Site 128
state: Ohio
city: Philadelphia
country: United States
facility: Sobi Site 127
state: Pennsylvania
city: York
country: United States
facility: Sobi Site 102
state: Pennsylvania
city: Rock Hill
country: United States
facility: Sobi Site 104
state: South Carolina
city: Dallas
country: United States
facility: Sobi Site 113
state: Texas
city: Salt Lake City
country: United States
facility: Sobi Site 108
state: Utah
Study officials:
References: