Lower starting dose of avatrombopag for immune thrombocytopenia (ITP)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, single-arm pilot conducted at a single center in Baghdad where adults with primary ITP who require second-line therapy will receive avatrombopag starting at 20 mg every other day instead of the standard 20 mg daily. Doses will be adjusted based on platelet response through a dose-adjustment phase, followed by a maintenance phase and a tapering/off-treatment follow-up phase. Treatment with avatrombopag is planned for up to six months with monitoring for platelet overshoot and adverse events. The trial aims to gather experience on dosing and to explore whether a lower starting dose improves safety while maintaining efficacy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female aged ≥18 years.
2. Diagnosis of primary ITP and having a platelet count of \< 30 x109/L measured within two weeks prior to inclusion with failure to achieve response or relapse after at least one cycle of dexamethasone (20-40 mg daily for 4 days) or prednisone /prednisolone (1 mg/kg for at least two weeks). Shorter courses or lower doses are allowed if discontinued or modified due to side effects.
3. Clinical need for second (subsequent) line treatment with a platelet elevating therapy assessed by the physician in charge.
4. Signed and dated written informed consent.

Exclusion Criteria:

1. Previous treatment with TPO-RA.
2. Pregnancy or lactation.
3. Patients with active serious bleeding or at high risk of bleeding as judged by physician in charge.
4. Females of child-bearing potential refusing to follow effective contraceptive methods (as described in SmPC) during treatment with Avatrombopag.
5. Secondary ITP defined as ITP secondary to lymphoma or chronic lymphocytic leukemia; ITP secondary to the following autoimmune disorders Systemic Lupus Erythematosus or Antiphospholipid Syndrome; ITP secondary to Common Variable Immune Deficiency; ITP secondary to the following viral infections eg Human Immunodeficiency Virus.
6. Concomitant autoimmune hemolytic anemia, Evans syndrome.
7. Presence of any serious comorbidity where the condition may worsen the study drugs.
8. Presence of active malignancy unless deemed cured by adequate treatment. Participants with the following neoplastic conditions can be included:

   * Monoclonal gammopathy of undetermined significance (MGUS) or monoclonal B lymphocytosis of undetermined significance (MBUS)
   * Basal/squamous cell carcinoma of the skin
   * Carcinoma in situ of the cervix
   * Carcinoma in situ of the breast
   * Incidental histological finding of prostate cancer (TNM stage T1a or T1b)
9. Patients with history of poor compliance or history of alcohol/drug abuse or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent.

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Where it's running

• hematology center / Medical City
  Baghdad, Iraq Recruiting

Study contacts

• Study coordinator: Alaa Alwan, MD
• Email: ala_sh73@yahoo.com
• Phone: 770 274 3114

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Multi-target drugs sequentially combine therapy in adults with newly diagnosed immune thrombocytopenia

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• CTX112 (zugo-cel) for relapsed/refractory ITP and wAIHA in adults

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• Efgartigimod IV for adolescents (12–17) with chronic immune thrombocytopenia

  This trial will try intravenous efgartigimod to see if it safely raises platelet counts in people aged 12 to 17 with chronic ITP.

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• Eltrombopag-related liver problems in immune thrombocytopenia

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• OM336 for autoimmune hemolytic anemia and immune thrombocytopenia

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• Registry for patients with Primary Immune Thrombocytopenia in Spain

  This study is collecting information from patients with Primary Immune Thrombocytopenia in Spain to better understand the condition and improve how it's treated.

  Recruiting at 29 sites Fundación Española de Hematología y Hemoterapía · A Coruña, A Coruña and 35 other locations · NCT06919341

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.