DEXAMETHASONE PHOSPHATE for Primary immune thrombocytopenia

Inclusion criteria

• {"criterion_text":"- 1.Age ≥ 18 years of age at the time of signing informed consent."}
• {"criterion_text":"- 2.Newly diagnosis of primary ITP according to the International Working Group assessment [1] and previously untreated for ITP."}
• {"criterion_text":"- 3.Platelet counts <30x109/L or ITP with platelet counts <50x109/L and concomitant bleeding symptoms."}
• {"criterion_text":"- 4.Serum creatinine concentration ≤1.5 mg/dL."}

Exclusion criteria

• {"criterion_text":"- 1.WHO performance status >2."}
• {"criterion_text":"- 2.Previous therapy with rituximab (within 3 months previous of study enrollment), corticosteroids, therapy with other immunomodulating agents within 1 month of enrolment, hematopoietic analogs and fostamatinib for any other reason than ITP."}
• {"criterion_text":"- 3.Previous use of romiplostim, PEG-recombinant human (rHu) megakaryocyte growth and development factor, eltrombopag, recombinant human anti-thrombopoietin (rHuTPO), or any plateletproducing agent for three months prior to enrolment."}
• {"criterion_text":"- 4.Alkylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study."}
• {"criterion_text":"- 5.Splenectomy within 3 months of the screening visit or planned splenectomy during study period."}
• {"criterion_text":"- 6.Abnormal renal function (serum creatinine > 1.5 mg/dL)."}
• {"criterion_text":"- 7.Active hepatic disease (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] levels >5 times the upper limit of normal)."}
• {"criterion_text":"- 8.Severe chronic liver disease as evidenced by, but not limited to, any of the following: International Normalized Ratio (INR) > 1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices."}
• {"criterion_text":"- 9.Pregnancy or lactation."}
• {"criterion_text":"- 10.Patients with known IgM seropositive tests for cytomegalovirus and/or Epstein-Barr virus in the previous month."}
• {"criterion_text":"- 11.Patients with known serum-positivity and a positive test for an active viral infection at screening with: Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), detectable virus charge of HIV."}
• {"criterion_text":"- 12.Intolerance to dexamethasone or romiplostim."}
• {"criterion_text":"- 13.History of a bone marrow stem cell disorder."}
• {"criterion_text":"- 14.Active or prior malignancy except adequately treated (ie, complete surgical excision with negative margins) basal cell carcinoma in the last 5 years.."}
• {"criterion_text":"- 15.History of Heliobacter pylori by urea breath test or stool antigen test within 6 months of enrollment, if available."}
• {"criterion_text":"- 16.History of myelodysplastic syndrome, systemic lupus erythematosus, or autoimmune cytopenia."}
• {"criterion_text":"- 17.History of antiphospholipid antibody syndrome."}
• {"criterion_text":"- 18.History of disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura."}
• {"criterion_text":"- 19.History of deep or superficial venous thromboembolism in the last 12 months or stroke, acute ischaemic heart disease or acute peripheral vascular disese in the last 6 months."}
• {"criterion_text":"- 20.Hypersensitivity to any recombinant Escherichia coli-derived product (eg, Infergen, Neupogen, Somatropin, and Actimmune) or known sensitivity to any of the products to be administered during dosing"}
• {"criterion_text":"- 21.Currently enrolled in another investigational device or drug study or < 30 days since ending another investigational device or drug studies, or receiving other investigational agents."}
• {"criterion_text":"- 22.Will have any other investigational procedures performed while enrolled in this clinical study."}
• {"criterion_text":"- 23.Pregnant or breastfeeding, or planning to become pregnant or breastfeed during treatment or within 1 month after the end of treatment."}
• {"criterion_text":"- 24.Female subject of childbearing potential is not willing to use, in combination with her partner, an acceptable method of effective contraception during treatment and for 1 month after the end of treatment (see annex 5 for additional contraception information). Females of childbearing potential should only be included after a negative, highly sensitive urine pregnancy test."}
• {"criterion_text":"- 25.Will not be available for protocol-required study visits, to the best of the subject's and investigator's knowledge."}
• {"criterion_text":"- 26.Any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures."}
• {"criterion_text":"- 27.Other serious comorbidities at investigator criteria."}

Primary endpoints

• {"endpoint_text":"- To evaluate the difference between study arms in the proportion of patients achieving 6mSROT-50 at 6 months (180 days) from treatment cessation. Definition of 6mSROT-50: platelets higher or equal than 50x109/L in the absence of any ITP treatment including any rescue treatment for at least 6 consecutive months (≥180 days) from treatment cessation and without WHO grade 2 or more bleeding.","definition_or_measurement_approach":"6mSROT-50 defined as platelets ≥ 50 x 10^9/L in the absence of any ITP treatment including any rescue treatment for at least 6 consecutive months (≥180 days) from treatment cessation and without WHO grade 2 or more bleeding; measured at 6 months (180 days) from treatment cessation."}

Secondary endpoints

• {"endpoint_text":"- -To evaluate the difference between study arms in the proportion of patients achieving 6mSROT-30 at 6 months (180 days) from treatment cessation.","definition_or_measurement_approach":"6mSROT-30: proportion with platelets ≥ 30 x 10^9/L in absence of any ITP treatment including rescue treatment for at least 6 consecutive months (≥180 days) from treatment cessation; measured at 6 months (180 days)."}
• {"endpoint_text":"- -To evaluate the difference between study arms in the proportion of patients achieving 12mSROT-50 at 12 months (365 days) from treatment cessation.","definition_or_measurement_approach":"12mSROT-50: proportion with platelets ≥ 50 x 10^9/L in absence of any ITP treatment including rescue treatment for at least 12 consecutive months (365 days) from treatment cessation; measured at 12 months (365 days)."}
• {"endpoint_text":"- -To evaluate the difference between study arms in the proportion of patients achieving 12mSROT-30 at 12 months (365 days) from treatment cessation","definition_or_measurement_approach":"12mSROT-30: proportion with platelets ≥ 30 x 10^9/L in absence of any ITP treatment including rescue treatment for at least 12 consecutive months (365 days) from treatment cessation; measured at 12 months (365 days)."}

Spain

Earliest CTIS Part Ii Submission Date

14-06-2024

Latest Decision Or Authorization Date

10-02-2026

Processing Time Days

606

Number Of Sites

15

Number Of Participants

66

Italy

Earliest CTIS Part Ii Submission Date

14-06-2024

Latest Decision Or Authorization Date

29-07-2025

Processing Time Days

410

Number Of Sites

6

Number Of Participants

20

Primary sponsor

Full Name

Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain