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

NCT04638829 | Completed Phase 4 Results FDA Drug

• 1 other identifier: AVA-ITP-401
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 20

Brief Summary

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

Conditions

Immune Thrombocytopenia

Keywords

ITP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change From Baseline TSQM Convenience Domain Score

  Day 90

• Change From Baseline TSQM Side Effects Domain Score

  Day 90

• Change From Baseline TSQM Effectiveness Domain Score

  Day 90

• Change From Baseline TSQM Global Satisfaction Domain Score

  Day 90

• Proportion of Subjects Who Have a Platelet Count Between ≥50×10^9/L to ≤200×10^9/L

  Day 15

Study Arms (1)

Avatrombopag

OTHER

Avatrombopag 20 mg oral tablet formulation for 90 days

Drug: Avatrombopag Oral Tablet

Interventions

Avatrombopag Oral Tablet DRUG

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

Also known as: Doptelet

Avatrombopag

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sobi, Inc.: lead

Study Sites (20)

Sobi Site 110

Tucson, Arizona, 85745, United States

Location

Sobi Site 119

Whittier, California, 90603, United States

Location

Sobi Site 123

Washington D.C., District of Columbia, 20010, United States

Location

Sobi Site 129

Miami, Florida, 33143, United States

Location

Sobi Site 120

Ocala, Florida, 34474, United States

Location

Sobi Site 125

St. Petersburg, Florida, 33709, United States

Location

Sobi Site 118

Tampa, Florida, 33606, United States

Location

Sobi Site 126

Chicago, Illinois, 60612, United States

Location

Sobi Site 109

Peoria, Illinois, 61614, United States

Location

Sobi Site 124

New Orleans, Louisiana, 70112, United States

Location

Sobi Site 101

Bethesda, Maryland, 20817, United States

Location

Sobi Site 103

Lincoln, Nebraska, 68506, United States

Location

Sobi Site 121

Chapel Hill, North Carolina, 27514, United States

Location

Sobi Site 116

Greenville, North Carolina, 27834, United States

Location

Sobi Site 128

Cleveland, Ohio, 44106, United States

Location

Sobi Site 127

Philadelphia, Pennsylvania, 19104, United States

Location

Sobi Site 102

York, Pennsylvania, 17403, United States

Location

Sobi Site 104

Rock Hill, South Carolina, 29732, United States

Location

Sobi Site 113

Dallas, Texas, 75246, United States

Location

Sobi Site 108

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

• Tarantino MD, Mosalpuria K, Kolodny S, Zhang J, Vredenburg M, Jamieson BD. Safety, efficacy, and treatment satisfaction in adults with ITP who switched to avatrombopag from another TPO-RA. Blood Adv. 2025 Jun 10;9(11):2733-2743. doi: 10.1182/bloodadvances.2024015635.

  PMID: 40101243 DERIVED

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

avatrombopag

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Medicine Development Leader
• Organization: Sobi,Inc.

medinfo.us@sobi.com

1-781-786-7370

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 20, 2020
• Study Start: March 15, 2021
• Primary Completion: January 3, 2024
• Study Completion: January 3, 2024
• Last Updated: January 16, 2025
• Results First Posted: January 16, 2025

Record last verified: 2024-12

Locations

US (20)