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

• Sponsor: Sobi, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04638829
• Collaborator: (none)
• Enrollment: 100
• Locations: 14
• Arm: 1
• Anticipated Duration (Months): 26.3
• Patients Per Site: 7.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Immune Thrombocytopenia	Drug: Avatrombopag Oral Tablet	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 15, 2021
• Anticipated Primary Completion Date: Mar 31, 2023
• Anticipated Study Completion Date: May 23, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Avatrombopag Avatrombopag 20 mg oral tablet formulation for 90 days	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; Other Names: Doptelet

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Platelet counts [Screening through Day 90 or End of Study]

   Evaluate the platelet counts after switching to avatrombopag from eltrombopag or romiplostim

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sobi Site 110	Tucson	Arizona	United States	85745
2	Sobi Site 119	Whittier	California	United States	90603
3	Sobi Site 120	Ocala	Florida	United States	34474
4	Sobi Site 118	Tampa	Florida	United States	33606
5	Sobi Site 109	Peoria	Illinois	United States	61614
6	Sobi Site 112	Greenfield	Indiana	United States	46140
7	Sobi Site 101	Bethesda	Maryland	United States	20817
8	Sobi Site 103	Lincoln	Nebraska	United States	68506
9	Sobi Site 121	Chapel Hill	North Carolina	United States	27514
10	Sobi Site 116	Greenville	North Carolina	United States	27834
11	Sobi Site 102	York	Pennsylvania	United States	17403
12	Sobi Site 104	Rock Hill	South Carolina	United States	29732
13	Sobi Site 113	Dallas	Texas	United States	75246
14	Sobi Site 108	Salt Lake City	Utah	United States	84132

Sponsors and Collaborators

• Sobi, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sobi, Inc.
• ClinicalTrials.gov Identifier: NCT04638829
• Other Study ID Numbers: AVA-ITP-401
• First Posted: Nov 20, 2020
• Last Update Posted: Jul 5, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sobi, Inc.: ITP
• Additional relevant MeSH terms: Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic

Study Results

No Results Posted as of Jul 5, 2022