Safety and Treatment Satisfaction in Adults With Chronic ITP After Switching to Avatrombopag From Eltrombopag or Romiplostim
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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 |
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Recruitment Status :
Recruiting
First Posted : November 20, 2020
Last Update Posted : May 12, 2022
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Sponsor:
Sobi, Inc.
Information provided by (Responsible Party):
Sobi, Inc.
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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 |
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 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Safety
| Arm | Intervention/treatment |
|---|---|
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Avatrombopag
Avatrombopag 20 mg oral tablet formulation for 90 days
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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 :
- 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 :
- 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
- 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
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| 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
| Contact: Sobi Clinical | 984-255-4872 | NAClincal@Sobi.com |
Locations
| 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.
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Sobi, Inc.:
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ITP |
Additional relevant MeSH terms:
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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 |