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

  • STATUS
    Recruiting
  • days left to enroll
    50
  • participants needed
    100
  • sponsor
    Dova Pharmaceuticals
Updated on 17 September 2021
thrombocytopenia
eltrombopag
romiplostim
avatrombopag

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.

Details
Condition IDIOPATHIC THROMBOCYTOPENIC PURPURA, Thrombocytopenic, Autoimmune Disease, Autoimmune disease, autoimmune thrombocytopenia, Immune Thrombocytopenia, Idiopathic Thrombocytopenic Purpura (ITP)
Treatment Avatrombopag Oral Tablet
Clinical Study IdentifierNCT04638829
SponsorDova Pharmaceuticals
Last Modified on17 September 2021

Eligibility

Yes No Not Sure

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 5010 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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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