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

Primary Purpose

Immune Thrombocytopenia

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Avatrombopag Oral Tablet
Sponsored by
Sobi, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring ITP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sobi Site 110
  • Sobi Site 119
  • Sobi Site 123
  • Sobi Site 129
  • Sobi Site 120
  • Sobi Site 125
  • Sobi Site 118
  • Sobi Site 126
  • Sobi Site 109
  • Sobi Site 124
  • Sobi Site 101
  • Sobi Site 103
  • Sobi Site 121
  • Sobi Site 116
  • Sobi Site 128
  • Sobi Site 127
  • Sobi Site 102
  • Sobi Site 104
  • Sobi Site 113
  • Sobi Site 108

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Avatrombopag

Arm Description

Avatrombopag 20 mg oral tablet formulation for 90 days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Subject reported outcomes
Evaluate the change in subject reported outcomes (TSQM questionnaire) from Baseline after switching to avatrombopag from eltrombopag or romiplostim
Platelet counts
Evaluate the platelet counts after switching to avatrombopag from eltrombopag or romiplostim

Full Information

First Posted
November 11, 2020
Last Updated
October 13, 2023
Sponsor
Sobi, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04638829
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
February 9, 2024 (Anticipated)
Study Completion Date
February 9, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sobi, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia
Keywords
ITP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Avatrombopag
Arm Type
Other
Arm Description
Avatrombopag 20 mg oral tablet formulation for 90 days
Intervention Type
Drug
Intervention Name(s)
Avatrombopag Oral Tablet
Other Intervention Name(s)
Doptelet
Intervention Description
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
Primary Outcome Measure Information:
Title
Safety and Tolerability (adverse events)
Description
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 Outcome Measure Information:
Title
Subject reported outcomes
Description
Evaluate the change in subject reported outcomes (TSQM questionnaire) from Baseline after switching to avatrombopag from eltrombopag or romiplostim
Time Frame
Screening through Day 90 or End of Study
Title
Platelet counts
Description
Evaluate the platelet counts after switching to avatrombopag from eltrombopag or romiplostim
Time Frame
Screening through Day 90 or End of Study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Sobi Site 110
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
Sobi Site 119
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Sobi Site 123
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Sobi Site 129
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Sobi Site 120
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Sobi Site 125
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Sobi Site 118
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Sobi Site 126
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Sobi Site 109
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Sobi Site 124
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Sobi Site 101
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Sobi Site 103
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Sobi Site 121
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Sobi Site 116
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Sobi Site 128
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Sobi Site 127
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Sobi Site 102
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Facility Name
Sobi Site 104
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Facility Name
Sobi Site 113
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Sobi Site 108
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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