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Tests treatment safety and results for ITP - Immune Thrombocytopenia
Official title Exploring the Efficacy, Safety of a Modified Starting Dosage of Avatrombopag in Immune Throbocytopenia (ITP) - a Pilot Study
ClinicalTrials.gov ID: NCT07133659
What this study is testing
What is Avatrombopag 20 mg Oral Tablet?
Avatrombopag 20 mg Oral Tablet is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for itp - immune thrombocytopenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-center, open label pilot trial where patients with primary ITP who require second line treatment will be offered avatrombopag at a reduced starting dose, adjusted thereafter according to the response and continued for up to 24 weeks. The study aims to acquire experience on use of avatrombopag and explore the efficacy and safety of lower starting dose of avatrombopag
- Phase 4: studies an already-approved treatment
- Time commitment: about 24 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female aged ≥18 years.
- 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...
- Clinical need for second (subsequent) line treatment with a platelet elevating therapy assessed by the physician in charge.
- Signed and dated written informed consent.
You likely can't join if
- Previous treatment with TPO-RA.
- Pregnancy or lactation.
- Patients with active serious bleeding or at high risk of bleeding as judged by physician in charge.
- Females of child-bearing potential refusing to follow effective contraceptive methods (as described in SmPC) during treatment with Avatrombopag.
- Secondary ITP defined as ITP secondary to lymphoma or chronic lymphocytic leukemia; ITP secondary to the following autoimmune disorders Systemic...
- Concomitant autoimmune hemolytic anemia, Evans syndrome.
See the full eligibility criteria
- Male or female aged ≥18 years.
- 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...
- Clinical need for second (subsequent) line treatment with a platelet elevating therapy assessed by the physician in charge.
- Signed and dated written informed consent.
- Previous treatment with TPO-RA.
- Pregnancy or lactation.
- Patients with active serious bleeding or at high risk of bleeding as judged by physician in charge.
- Females of child-bearing potential refusing to follow effective contraceptive methods (as described in SmPC) during treatment with Avatrombopag.
- 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...
- Concomitant autoimmune hemolytic anemia, Evans syndrome.
- Presence of any serious comorbidity where the condition may worsen the study drugs.
- 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)
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Baghdad, Iraq
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baghdad, Iraq. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.