ITP - Immune ThrombocytopeniaPhase 4Ava dosingNCT07133659
Exploring the Efficacy, Safety of a Modified Starting Dosage of Avatrombopag in Immune Throbocytopenia (ITP) - a Pilot Study
A Phase 4 study testing Avatrombopag 20 mg Oral Tablet in people with ITP - Immune Thrombocytopenia, run by Al-Mustansiriyah University at 1 site in Iraq.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ITP - Immune Thrombocytopenia
- What is being tested?
- Avatrombopag 20 mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteIraq
- Study dates
- 8 Jun 2025to 8 Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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.
- Clinical need for second (subsequent) line treatment with a platelet elevating therapy assessed by the physician in charge.
- Signed and dated written informed consent.
Who cannot join
- 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 Variable Immune Deficiency; ITP secondary to the following viral infections eg Human Immunodeficiency Virus.
- Concomitant autoimmune hemolytic anemia, Evans syndrome.
Show all 15Show fewer
- 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 disease that might interfere with the ability to comply with the study protocol or give informed consent.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site, 1 recruiting
- Recruiting
hematology center / Medical City
Baghdad, 10016
Alaa Alwan, MD, 0770 274 3114 ext. 00964, ala_sh73@yahoo.com
About this study
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
Read the detailed description
Avatrombopag is an oral thrombopoietin receptor agonist that is licensed for chronic ITP. Avatrombopag is administered at a starting dose of 20 mg daily. Overshooting of platelet count is a frequent problem that occurs in 20 to 40% of the patients after initiating avatrombopag as recommended. In this open label, single arm, pilot study, we will start avatrombopag at a reduced starting dose of 20 mg every other day. The dose will be adjusted thereafter according to the platelet response. The study consists of 3 phases: Dose adjustment phase, a maintenance phase, and dose tapering/disconsolation and follow-up phase. The study aims to acquire experience on use of avatrombopag and explore the efficacy and safety of lower starting avatrombopag-dose, and assess the rate of sustained response off-treatment. The duration of treatment with avatrombopag is 6 months.
The study is an investigator-initiated trial sponsored by Center for Transplantation and Blood Diseases. Medical City Complex, Baghdad Iraq.
- Conditions
- ITP - Immune Thrombocytopenia
- Being tested
- Avatrombopag 20 mg Oral Tablet
- Keywords
- ITP, thrombocytopenia, Avatrombopag, thrombopoietin receptor agonist
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avatrombopag 20 mg Oral TabletDrug
Description: Patients will start on avatrombopag 20 mg every other day for a week then the dose will be readjusted according to the platelet count.
| Study group | Role | What they receive |
|---|---|---|
| Avatrombopag | Experimental | Description: Patients will start on avatrombopag 20 mg every other day for a week then the dose will be readjusted according to the platelet count. Receives: Drug: Avatrombopag 20 mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Response Time
Median cumulative number of weeks with platelet count >50 x 109/L from time of Avatrombopag initiation to end of week 20. A period of 2 week will be deducted after IVIG and 4 weeks after dexamethasone.
Measured: 20 weeks
Secondary outcomes (9)
TTR
Time from initiation of dose to first platelet count > 50 x 109/L without any rescue therapy during the 2 weeks prior to the blood sampling.
Measured: 20 weeks
Response by day 8
Number of patients achieving platelet count > 50 x 109/L by day 8 without any rescue therapy during the 2 weeks prior to the blood sampling.
Measured: 8 days
Rates of platelet overshoot.
Number of episode with platelet count > 200 and >400 x 109/L during the first 6 weeks after the initiation of avatrombopag.
Measured: 6 weeks
Durable response rate.
Number of patients achieving 4 consecutive platelet counts > 50 x 109/L between weeks 12 and 20 including the last count, without the use of rescue therapy, corticosteroids or any platelet elevating agent after week 6.
Measured: 20 weeks
The rates of treatment failure.
Occurrence of treatment failure is defined as:
Discontinuation of Avatrombopag and switching to another platelet elevating agent between weeks 6 and 20 due to non-response or intolerance to Avatrombopag or administration of rescue therapy after week 6 and Thrombocytopenia (platelet count <30 x 109/L), high risk of bleeding or intolerance to avatrombopag.
Measured: 20 weeks
Bleeding complications during the study.
Number and severity of WHO bleeding events.
Measured: 52 weeks
The safety of treatment with Avatrombopag.
Occurrence and severity of treatment emergent adverse events. Occurrence and severity of adverse events of special interest including arterial and venous thrombosis and bone marrow fibrosis (bone marrow biopsy showing MF2 or higher).
Measured: 52 weeks
The changes in HRQoL during the study.
Change in of SF-36 (v1) questionnaires from baseline to weeks 20.
Measured: 20 weeks
The rates of Sustained Response Off-Treatment (SROT) at week 52.
Occurrence of SROT defined as:
A platelet count > 30 x 109/L in all planned visits between the time of discontinuation of Avatrombopag and week 52 including week 52 and no administration of platelet elevating agent between weeks 20 and 52.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start8 Jun 2025
- Primary completion8 Jul 2026 (estimated)
- Study completion8 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for ITP - Immune ThrombocytopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Mustansiriyah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Fadhil Alwan, Al-Mustansiriyah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133659
- Sponsor's protocol ID
- RGHC007
- Acronym
- Ava dosing
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guillet S, Crickx E, Azzaoui I, Chappert P, Boutin E, Viallard JF, Riviere E, Gobert D, Galicier L, Malphettes M, Cheze S, Lefrere F, Audia S, Bonnotte B, Lambotte O, Noel N, Fain O, Moulis G, Hamidou M, Gerfaud-Valentin M, Marolleau JP, Terriou L, Martis N, Morin AS, Perlat A, Le Gallou T, Roy-Peaud F, Robbins A, Lega JC, Puyade M, Comont T, Limal N, Languille L, Zarrour A, Luka M, Menager M, Belmondo T, Hue S, Canoui-Poitrine F, Michel M, Godeau B, Mahevas M. Prolonged response after TPO-RA discontinuation in primary ITP: results of a prospective multicenter study. Blood. 2023 Jun 8;141(23):2867-2877. doi: 10.1182/blood.2022018665.
PubMed 36893453Pascual-Izquierdo C, Sanchez-Gonzalez B, Canaro-Hirnyk MI, Garcia-Donas G, Menor-Gomez M, Gil-Fernandez JJ, Monsalvo-Saornil S, de-Laiglesia A, Alvarez-Roman MT, Jarque-Ramos I, Llacer MJ, Pedrote-Amador B, Zafra-Torres D, Caparros-Miranda I, Ortuzar-Pasalodos A, Revilla-Calvo N, Bastida JM, Chica-Gullon E, Alvarellos M, Jimenez-Barcenas R, Bernat S, Martinez-Carballeira D, Lakhwani S, Lopez-Ansoar E, Moreno-Beltran ME, Lorenzo-Vizcaya A, Aguirre MA, Lasa-Eguialde M, Canet M, Gonzalez-Gascon-Y-Marin IT, Caballero-Navarro G, Cuesta A, Diaz-Lopez M, Arquero T, Moreno-Carbonell M, Mingot-Castellano ME; Spanish ITP Group (GEPTI) of the Spanish Society of Hematology and Hemotherapy (SEHH). Avatrombopag in immune thrombocytopenia: A real-world study of the Spanish ITP Group (GEPTI). Am J Hematol. 2024 Dec;99(12):2328-2339. doi: 10.1002/ajh.27498. Epub 2024 Oct 12.
PubMed 39394928Virk ZM, Leaf RK, Kuter DJ, Goodarzi K, Connell NT, Connors JM, Al-Samkari H. Avatrombopag for adults with early versus chronic immune thrombocytopenia. Am J Hematol. 2024 Feb;99(2):155-162. doi: 10.1002/ajh.27080. Epub 2023 Dec 8.
PubMed 38063420Yamaguchi H, Iino M, Kowata S, Yamamoto R, Yamanouchi J, Imamura Y, Kirito K, Yokoyama K, Ito T, Ishikawa T, Shiratsuchi M, Tomiyama Y, Kamiya H, Zhang J, Jamieson BD. A phase 3 study of the efficacy and safety of avatrombopag in Japanese adults with chronic immune thrombocytopenia. Int J Hematol. 2025 Oct;122(4):521-532. doi: 10.1007/s12185-025-04001-4. Epub 2025 May 20.
PubMed 40392465Tarantino MD, Bussel JB, Lee EJ, Jamieson BD. A phase 3, randomized, double-blind, active-controlled trial evaluating efficacy and safety of avatrombopag versus eltrombopag in ITP. Br J Haematol. 2023 Aug;202(4):897-899. doi: 10.1111/bjh.18908. Epub 2023 Jun 20. No abstract available.
PubMed 37339869Mei H, Zhou H, Hou M, Sun J, Zhang L, Luo J, Jiang Z, Ye X, Xu Y, Lu J, Wang H, Hui A, Zhou Y, Hu Y. Avatrombopag for adult chronic primary immune thrombocytopenia: a randomized phase 3 trial in China. Res Pract Thromb Haemost. 2023 Jul 26;7(6):102158. doi: 10.1016/j.rpth.2023.102158. eCollection 2023 Aug.
PubMed 37700877Jurczak W, Chojnowski K, Mayer J, Krawczyk K, Jamieson BD, Tian W, Allen LF. Phase 3 randomised study of avatrombopag, a novel thrombopoietin receptor agonist for the treatment of chronic immune thrombocytopenia. Br J Haematol. 2018 Nov;183(3):479-490. doi: 10.1111/bjh.15573. Epub 2018 Sep 7.
PubMed 30191972Matzdorff A, Alesci SR, Gebhart J, Holzhauer S, Hutter-Kronke ML, Kuhne T, Meyer O, Ostermann H, Pabinger I, Rummel M, Sachs UJ, Stauch T, Trautmann-Grill K, Wormann B. Expert Report on Immune Thrombocytopenia: Current Diagnostics and Treatment - Recommendations from an Expert Group from Austria, Germany, and Switzerland. Oncol Res Treat. 2023;46 Suppl 2:5-44. doi: 10.1159/000529662. Epub 2023 Feb 14. No abstract available.
PubMed 36787705Neunert C, Terrell DR, Arnold DM, Buchanan G, Cines DB, Cooper N, Cuker A, Despotovic JM, George JN, Grace RF, Kuhne T, Kuter DJ, Lim W, McCrae KR, Pruitt B, Shimanek H, Vesely SK. American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood Adv. 2019 Dec 10;3(23):3829-3866. doi: 10.1182/bloodadvances.2019000966.
PubMed 31794604Provan D, Arnold DM, Bussel JB, Chong BH, Cooper N, Gernsheimer T, Ghanima W, Godeau B, Gonzalez-Lopez TJ, Grainger J, Hou M, Kruse C, McDonald V, Michel M, Newland AC, Pavord S, Rodeghiero F, Scully M, Tomiyama Y, Wong RS, Zaja F, Kuter DJ. Updated international consensus report on the investigation and management of primary immune thrombocytopenia. Blood Adv. 2019 Nov 26;3(22):3780-3817. doi: 10.1182/bloodadvances.2019000812.
PubMed 31770441Rodeghiero F, Stasi R, Gernsheimer T, Michel M, Provan D, Arnold DM, Bussel JB, Cines DB, Chong BH, Cooper N, Godeau B, Lechner K, Mazzucconi MG, McMillan R, Sanz MA, Imbach P, Blanchette V, Kuhne T, Ruggeri M, George JN. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009 Mar 12;113(11):2386-93. doi: 10.1182/blood-2008-07-162503. Epub 2008 Nov 12.
PubMed 19005182Ghanima W, Godeau B, Cines DB, Bussel JB. How I treat immune thrombocytopenia: the choice between splenectomy or a medical therapy as a second-line treatment. Blood. 2012 Aug 2;120(5):960-9. doi: 10.1182/blood-2011-12-309153. Epub 2012 Jun 26.
PubMed 22740443
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Efficacy, Safety of a Modified Starting Dosage of Avatrombopag in Immune Throbocytopenia (ITP) - a Pilot Study
- ClinicalTrials.gov ID
- NCT07133659
- Acronym / sponsor ID
- Ava dosing / RGHC007
- Conditions
- ITP - Immune Thrombocytopenia
- Keywords
- ITP, thrombocytopenia, Avatrombopag, thrombopoietin receptor agonist
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Al-Mustansiriyah UniversityUniversity, hospital or other
- Study start
- 8 Jun 2025 (actual)
- Primary completion
- 8 Jul 2026 (estimated)
- Study completion
- 8 Jul 2027 (estimated)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Avatrombopag is an oral thrombopoietin receptor agonist that is licensed for chronic ITP. Avatrombopag is administered at a starting dose of 20 mg daily. Overshooting of platelet count is a frequent problem that occurs in 20 to 40% of the patients after initiating avatrombopag as recommended. In this open label, single arm, pilot study, we will start avatrombopag at a reduced starting dose of 20 mg every other day. The dose will be adjusted thereafter according to the platelet response. The study consists of 3 phases: Dose adjustment phase, a maintenance phase, and dose tapering/disconsolation and follow-up phase. The study aims to acquire experience on use of avatrombopag and explore the efficacy and safety of lower starting avatrombopag-dose, and assess the rate of sustained response off-treatment. The duration of treatment with avatrombopag is 6 months.
The study is an investigator-initiated trial sponsored by Center for Transplantation and Blood Diseases. Medical City Complex, Baghdad Iraq.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avatrombopag | Experimental | Drug: Avatrombopag 20 mg Oral TabletDescription: Patients will start on avatrombopag 20 mg every other day for a week then the dose will be readjusted according to the platelet count. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 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.
- Clinical need for second (subsequent) line treatment with a platelet elevating therapy assessed by the physician in charge.
- Signed and dated written informed consent.
Key exclusion criteria (15 listed)
- 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 Variable Immune Deficiency; ITP secondary to the following viral infections eg Human Immunodeficiency Virus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avatrombopag 20 mg Oral TabletDescription: Patients will start on avatrombopag 20 mg every other day for a week then the dose will be readjusted according to the platelet count. | Drug | Avatrombopag |
Primary outcome
Total Response Time
Time frame: 20 weeks
Median cumulative number of weeks with platelet count >50 x 109/L from time of Avatrombopag initiation to end of week 20. A period of 2 week will be deducted after IVIG and 4 weeks after dexamethasone.
9 secondary outcomes
TTR
Time frame: 20 weeks
Response by day 8
Time frame: 8 days
Rates of platelet overshoot.
Time frame: 6 weeks
Durable response rate.
Time frame: 20 weeks
The rates of treatment failure.
Time frame: 20 weeks
Bleeding complications during the study.
Time frame: 52 weeks
The safety of treatment with Avatrombopag.
Time frame: 52 weeks
The changes in HRQoL during the study.
Time frame: 20 weeks
The rates of Sustained Response Off-Treatment (SROT) at week 52.
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Background: PubMed 36893453Guillet S, Crickx E, Azzaoui I, Chappert P, Boutin E, Viallard JF, Riviere E, Gobert D, Galicier L, Malphettes M, Cheze S, Lefrere F, Audia S, Bonnotte B, Lambotte O, Noel N, Fain O, Moulis G, Hamidou M, Gerfaud-Valentin M, Marolleau JP, Terriou L, Martis N, Morin AS, Perlat A, Le Gallou T, Roy-Peaud F, Robbins A, Lega JC, Puyade M, Comont T, Limal N, Languille L, Zarrour A, Luka M, Menager M, Belmondo T, Hue S, Canoui-Poitrine F, Michel M, Godeau B, Mahevas M. Prolonged response after TPO-RA discontinuation in primary ITP: results of a prospective multicenter study. Blood. 2023 Jun 8;141(23):2867-2877. doi: 10.1182/blood.2022018665.
- Background: PubMed 39394928Pascual-Izquierdo C, Sanchez-Gonzalez B, Canaro-Hirnyk MI, Garcia-Donas G, Menor-Gomez M, Gil-Fernandez JJ, Monsalvo-Saornil S, de-Laiglesia A, Alvarez-Roman MT, Jarque-Ramos I, Llacer MJ, Pedrote-Amador B, Zafra-Torres D, Caparros-Miranda I, Ortuzar-Pasalodos A, Revilla-Calvo N, Bastida JM, Chica-Gullon E, Alvarellos M, Jimenez-Barcenas R, Bernat S, Martinez-Carballeira D, Lakhwani S, Lopez-Ansoar E, Moreno-Beltran ME, Lorenzo-Vizcaya A, Aguirre MA, Lasa-Eguialde M, Canet M, Gonzalez-Gascon-Y-Marin IT, Caballero-Navarro G, Cuesta A, Diaz-Lopez M, Arquero T, Moreno-Carbonell M, Mingot-Castellano ME; Spanish ITP Group (GEPTI) of the Spanish Society of Hematology and Hemotherapy (SEHH). Avatrombopag in immune thrombocytopenia: A real-world study of the Spanish ITP Group (GEPTI). Am J Hematol. 2024 Dec;99(12):2328-2339. doi: 10.1002/ajh.27498. Epub 2024 Oct 12.
- Background: PubMed 38063420Virk ZM, Leaf RK, Kuter DJ, Goodarzi K, Connell NT, Connors JM, Al-Samkari H. Avatrombopag for adults with early versus chronic immune thrombocytopenia. Am J Hematol. 2024 Feb;99(2):155-162. doi: 10.1002/ajh.27080. Epub 2023 Dec 8.
- Background: PubMed 40392465Yamaguchi H, Iino M, Kowata S, Yamamoto R, Yamanouchi J, Imamura Y, Kirito K, Yokoyama K, Ito T, Ishikawa T, Shiratsuchi M, Tomiyama Y, Kamiya H, Zhang J, Jamieson BD. A phase 3 study of the efficacy and safety of avatrombopag in Japanese adults with chronic immune thrombocytopenia. Int J Hematol. 2025 Oct;122(4):521-532. doi: 10.1007/s12185-025-04001-4. Epub 2025 May 20.
- Background: PubMed 37339869Tarantino MD, Bussel JB, Lee EJ, Jamieson BD. A phase 3, randomized, double-blind, active-controlled trial evaluating efficacy and safety of avatrombopag versus eltrombopag in ITP. Br J Haematol. 2023 Aug;202(4):897-899. doi: 10.1111/bjh.18908. Epub 2023 Jun 20. No abstract available.
- Background: PubMed 37700877Mei H, Zhou H, Hou M, Sun J, Zhang L, Luo J, Jiang Z, Ye X, Xu Y, Lu J, Wang H, Hui A, Zhou Y, Hu Y. Avatrombopag for adult chronic primary immune thrombocytopenia: a randomized phase 3 trial in China. Res Pract Thromb Haemost. 2023 Jul 26;7(6):102158. doi: 10.1016/j.rpth.2023.102158. eCollection 2023 Aug.
- Background: PubMed 30191972Jurczak W, Chojnowski K, Mayer J, Krawczyk K, Jamieson BD, Tian W, Allen LF. Phase 3 randomised study of avatrombopag, a novel thrombopoietin receptor agonist for the treatment of chronic immune thrombocytopenia. Br J Haematol. 2018 Nov;183(3):479-490. doi: 10.1111/bjh.15573. Epub 2018 Sep 7.
- Background: PubMed 36787705Matzdorff A, Alesci SR, Gebhart J, Holzhauer S, Hutter-Kronke ML, Kuhne T, Meyer O, Ostermann H, Pabinger I, Rummel M, Sachs UJ, Stauch T, Trautmann-Grill K, Wormann B. Expert Report on Immune Thrombocytopenia: Current Diagnostics and Treatment - Recommendations from an Expert Group from Austria, Germany, and Switzerland. Oncol Res Treat. 2023;46 Suppl 2:5-44. doi: 10.1159/000529662. Epub 2023 Feb 14. No abstract available.
- Background: PubMed 31794604Neunert C, Terrell DR, Arnold DM, Buchanan G, Cines DB, Cooper N, Cuker A, Despotovic JM, George JN, Grace RF, Kuhne T, Kuter DJ, Lim W, McCrae KR, Pruitt B, Shimanek H, Vesely SK. American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood Adv. 2019 Dec 10;3(23):3829-3866. doi: 10.1182/bloodadvances.2019000966.
- Background: PubMed 31770441Provan D, Arnold DM, Bussel JB, Chong BH, Cooper N, Gernsheimer T, Ghanima W, Godeau B, Gonzalez-Lopez TJ, Grainger J, Hou M, Kruse C, McDonald V, Michel M, Newland AC, Pavord S, Rodeghiero F, Scully M, Tomiyama Y, Wong RS, Zaja F, Kuter DJ. Updated international consensus report on the investigation and management of primary immune thrombocytopenia. Blood Adv. 2019 Nov 26;3(22):3780-3817. doi: 10.1182/bloodadvances.2019000812.
- Background: PubMed 19005182Rodeghiero F, Stasi R, Gernsheimer T, Michel M, Provan D, Arnold DM, Bussel JB, Cines DB, Chong BH, Cooper N, Godeau B, Lechner K, Mazzucconi MG, McMillan R, Sanz MA, Imbach P, Blanchette V, Kuhne T, Ruggeri M, George JN. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009 Mar 12;113(11):2386-93. doi: 10.1182/blood-2008-07-162503. Epub 2008 Nov 12.
- Background: PubMed 22740443Ghanima W, Godeau B, Cines DB, Bussel JB. How I treat immune thrombocytopenia: the choice between splenectomy or a medical therapy as a second-line treatment. Blood. 2012 Aug 2;120(5):960-9. doi: 10.1182/blood-2011-12-309153. Epub 2012 Jun 26.
- Individual participant dataSharing planned: No
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Warm Autoimmune Hemolytic Anemia (WAIHA), ITP - Immune Thrombocytopenia
RecruitingPhase 2/3
A Study of Efgartigimod IV in Participants From 12 Years to Less Than 18 Years of Age With Chronic Immune Thrombocytopenia (ITP)
Immune Thrombocytopenia (ITP), ITP - Immune Thrombocytopenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Avatrombopag 20 mg Oral Tablet in people with ITP - Immune Thrombocytopenia, run by Al-Mustansiriyah University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alaa Alwan, MD (770 274 3114 ext. 00964, ala_sh73@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Response Time (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07133659, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025; AzTrials last refreshed its copy on 26 Oct 2026.