Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04638829
Recruitment Status : Recruiting
First Posted : November 20, 2020
Last Update Posted : May 12, 2022
Sponsor:
Information provided by (Responsible Party):
Sobi, Inc.

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 15, 2021
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : May 23, 2023


Arm Intervention/treatment
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 Name: Doptelet




Primary Outcome Measures :
  1. Safety and Tolerability (adverse events) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Screening through Day 90 or End of Study ]
    Evaluate the platelet counts after switching to avatrombopag from eltrombopag or romiplostim



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04638829


Contacts
Layout table for location contacts
Contact: Sobi Clinical 984-255-4872 NAClincal@Sobi.com

Locations
Layout table for location information
United States, Arizona
Sobi Site Recruiting
Tucson, Arizona, United States, 85745
United States, California
Sobi Site Recruiting
Whittier, California, United States, 90603
United States, Florida
Sobi Site Recruiting
Ocala, Florida, United States, 34474
United States, Illinois
Sobi Site Recruiting
Peoria, Illinois, United States, 61615
United States, Indiana
Sobi Site Withdrawn
Greenfield, Indiana, United States, 46140
United States, Maryland
Sobi Site Recruiting
Bethesda, Maryland, United States, 20817
United States, Nebraska
Sobi Site Recruiting
Lincoln, Nebraska, United States, 68506
United States, North Carolina
Sobi SIte Recruiting
Chapel Hill, North Carolina, United States, 27514
Sobi Site Recruiting
Greenville, North Carolina, United States, 27834
United States, Pennsylvania
Sobi Site Recruiting
York, Pennsylvania, United States, 17403
United States, South Carolina
Sobi site Recruiting
Rock Hill, South Carolina, United States, 29732
United States, Texas
Sobi Site Recruiting
Dallas, Texas, United States, 75246
United States, Utah
Sobi Site Recruiting
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Sobi, Inc.
Layout table for additonal information
Responsible Party: Sobi, Inc.
ClinicalTrials.gov Identifier: NCT04638829    
Other Study ID Numbers: AVA-ITP-401
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: May 12, 2022
Last Verified: May 2022

Layout table for additional information
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:
Layout table for MeSH terms
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations