Avatrombopag in the Treatment of Primary Immune Thrombocytopenia(ITP)

June 24, 2021 updated by: Ming Hou, Shandong University

Avatrombopag in the Treatment of Primary Immune Thrombocytopenia(ITP): a Single-arm, Multi-centre, Observational Study

The project was undertaking by Qilu Hospital of Shandong University and other well-known hospitals in China. Aims at evaluating effectiveness and safety of avatrombopag in the treatment of primary immune thrombocytopenia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators are undertakingSingle-arm, multi-Centre, Observational study of 400 Patients with primary immune thrombocytopenia (ITP) from Qilu Hospital of Shandong University and other well-known hospitals in China. ITP patients will be given one tablet (20 mg) of avatrombopag daily.If the platelet count is higher than 150×10^9/L, the dose should be reduced. Prolonged dosing intervals or a combination of reduced daily dose are preferred.If the drug was taken for ≥1 week and the platelet count was still less than 30×10^9/L, the dosage should be increased. The maximum dose is 40 mg daily. Aplatelet count,AE, laboratory parameters, ECG, vital signs and other symptoms will be evaluated before and after treatment. Adverse events will be recorded throughout the study.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Qilu Hospital, Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

  1. Aged 18+ years, male or female;
  2. Ever been diagnosed as ITP patients. The diagnostic criteria comply with the "Chinese Guidelines for the Diagnosis and Treatment of Adult Primary Immune Thrombocytopenia (2020 Edition)"

Description

Inclusion Criteria:

  1. Aged 18+ years, male or female;

  2. Ever been diagnosed as ITP patients. The diagnostic criteria comply with the "Chinese Guidelines for the Diagnosis and Treatment of Adult Primary Immune Thrombocytopenia (2020 Edition)"

    1. At least 2 consecutive blood tests showed a decrease in platelet count; no obvious abnormality in the morphology of blood cells by peripheral blood smear microscopy.
    2. Spleen is generally not enlarged.
    3. Bone marrow examination: the morphological characteristics of bone marrow cells in ITP patients were increased or normal megakaryocytes with maturation disorders.
    4. Other secondary thrombocytopenia must be excluded: autoimmune diseases, thyroid disease, lymphoproliferative disorders, myelodysplastic syndrome (MDS), aplastic anemia (AA), various malignant hematologic diseases, tumor infiltration, Chronic liver disease, hypersplenism, common variant immunodeficiency disease (CVID), infection, vaccination causing secondary thrombocytopenia; Thrombocytopenia due to depletion; Drug induced thrombocytopenia; Alloimmune thrombocytopenia; Thrombocytopenia during pregnancy; Congenital thrombocytopenia and pseudo-thrombocytopenia;
  3. ECOG general status score ≤ 2;
  4. Platelet count < 30×10^9/L；platelet count ≥< 30×10^9/L accompanied by active bleeding; If the platelet count is around 30×10^9/L and no active bleeding, a second examination must be performed to further confirm the platelet count.
  5. Voluntarily signed the informed consent.
  6. Any other circumstances that the investigator considers appropriate for the patient to participate in the study.

Exclusion Criteria:

  1. Patients with secondary thrombocytopenia.
  2. Currently receiving other TPO-RAs, rhIL-11 and rhTPO treatment, and subjects are unwilling to switch to avatrombopag treatment.
  3. Patients with severe insufficiency of heart, lung, liver and kidney.
  4. Pregnant or breast-feeding, or contraceptive measures cannot be taken during the trial.
  5. Subjects participated in clinical studies of other investigational drugs or devices within 30 days prior to screening.
  6. Having a history of psychotropic drug abuse and unable to quit or having mental disorders.
  7. Having significant factors that affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.
  8. Subject is allergic to avatrombopag or any of its excipients;
  9. Any other circumstances that the investigator considers inappropriate for the patient to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with primary immune thrombocytopenia (ITP)
Ever been diagnosed as ITP patients. The diagnostic criteria comply with the "Chinese Guidelines for the Diagnosis and Treatment of Adult Primary Immune Thrombocytopenia (2020 Edition)"
Drug: Avatrombopag
Avatrombopag is an orally bioavailable, small molecule thrombopoietin receptor agonist that has been developed by Dova Pharmaceuticals for the treatment of thrombocytopenic disorders.
Other Names:
  • Doptelet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants achieving platelet response on day 28 of treatment
Time Frame: on day 28 of treatment
Percentage of participants achieving platelet response on day 28 of treatment. Platelet response rate refers to the platelet count PLT≥30×109/L and increases at least 2 times from the baseline value without bleeding in the absence of remedial therapy.
on day 28 of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants achieving platelet response on day 8 of treatment.
Time Frame: on day 8 of treatment.
Percentage of participants achieving platelet response on day 8 of treatment. Platelet response rate refers to the platelet count PLT≥30×109/L and increases at least 2 times from the baseline value without bleeding in the absence of remedial therapy.
on day 8 of treatment.
Percentage of participants achieving platelet response on day 14 of treatment.
Time Frame: on day 14 of treatment.
Percentage of participants achieving platelet response on day 14 of treatment. Platelet response rate refers to the platelet count PLT≥30×109/L and increases at least 2 times from the baseline value without bleeding in the absence of remedial therapy.
on day 14 of treatment.
Changes in participants' bleeding scores.
Time Frame: through study completion, an average of 6 months
Thrombocytopenia bleeding scoring system is used to evaluate the changes in participants' bleeding scores.
through study completion, an average of 6 months
Evaluation of adverse effects related to avatrombopag.
Time Frame: through study completion, an average of 6 months
Evaluation of adverse effects related to avatrombopag including side effect,toxic reaction,post effect,anaphylactic reaction.
through study completion, an average of 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants achieving platelet response (R) at the second month of treatment.
Time Frame: at the second month of treatment
Percentage of participants achieving the platelet count PLT≥30×109/L and increases at least 2 times from the baseline value without bleeding in the absence of remedial therapy at the second month of treatment.
at the second month of treatment
Participants' 6-month continuous remission rate.
Time Frame: 6 month of treatment
Percentage of participants achieving 6-month continuous remission including symptoms associated with bleeding and mental symptoms
6 month of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Investigators

  • Principal Investigator: Ming Hou, MD PhD, Shandong University Qilu Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

May 13, 2021

First Submitted That Met QC Criteria

June 24, 2021

First Posted (Actual)

July 2, 2021

Study Record Updates

Last Update Posted (Actual)

July 2, 2021

Last Update Submitted That Met QC Criteria

June 24, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKX-2007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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