Primary Immune ThrombocytopeniaPhase 3RODEXNCT05325593
Romiplostim Plus Dexamethasone vs Dexamethasone in Patients With Newly Diagnosed Primary Immune Thrombocytopenia
A Phase 3 study testing romiplostim plus dexamethasone and Dexamethasone in people with Primary Immune Thrombocytopenia, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 30 sites in 3 countries.
Trial summary
Phase III, open-labeled, randomized and multicenter clinical trial to evaluate the superiority of romiplostim plus dexamethasone vs dexamethasone alone in patients with newly diagnosed primary immune thrombocytopenia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Immune Thrombocytopenia
- What is being tested?
- romiplostim plus dexamethasone and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 30 sitesin 3 countries
- Study dates
- 2 Dec 2022to 24 Oct 2026
- Phase
- Phase 3
- 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
Main inclusion criteria:
- Age ≥ 18 years of age at the time of signing informed consent.
- Newly diagnosis of primary ITP according to the International Working Group assessment [1] and previously untreated for ITP.
- Platelet counts <30x109/L or ITP with platelet counts <50x109/L and concomitant bleeding symptoms.
- Serum creatinine concentration ≤1.5 mg/dL.
Main exclusion criteria:
- World Health Organization's performance status >2.
- Previous therapy with rituximab (within 3 months previous of study enrollment), corticosteroids or, therapy with other immunomodulating agents within 1 month before of enrolment;,prior use of hematopoietic analogs and or fostamatinib for any other reason despite ITP three months before enrolment.
- Previous use of romiplostim, polyethylene glycol-recombinant human megakaryocyte growth and development factor, Eltrombopag, recombinant human anti-thrombopoietin, or any platelet-producing agent three months before enrolment.
- Alkylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study.
- Splenectomy within 3 months of the screening visit or planned splenectomy during study period.
- Abnormal renal function (serum creatinine > 1.5 mg/dL).
- Active hepatic disease (evidenced by alanine aminotransferase [ALT] or aspartate aminotransferase [AST] levels >5 times the upper limit of normal (it will only be necessary to determine one of the two transaminases
- Severe chronic liver disease as evidenced by, but not limited to, any of the following: International Normalized Ratio >1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.
- Patients with known immunoglobulin M seropositive tests for cytomegalovirus and/or Epstein-Barr virus in the previous month.
- Patients with an active viral infection at screening with: Hepatitis B Virus, Hepatitis C Virus, detectable virus charge of HIV.
- Intolerance to dexamethasone.
- History of a bone marrow stem cell disorder.
- Active or prior malignancy except adequately treated (ie, complete surgical excision with negative margins) basal cell carcinoma.
- History of helicobacter pylori by urea breath test or stool antigen test within 6 months of enrollment, if available.
- History of myelodysplastic syndrome, systemic lupus erythematosus, or autoimmune cytopenia.
- History of antiphospholipid antibody syndrome.
- History of disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura.
- History of deep or superficial venous thromboembolism in the last 12 months or stroke, acute ischaemic heart disease or acute peripheral vascular disease in the last 6 months.
- 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
- 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.
- Will have any other investigational procedures performed while enrolled in this clinical study.
- Pregnant or breastfeeding, or planning to become pregnant or breastfeed during treatment or within 1 month after the end of treatment.
- 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. Females of childbearing potential should only be included after a negative, pregnancy test.
- Will not be available for protocol-required study visits, to the best of the subject's and investigator's knowledge.
- 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.
- Other serious comorbidities at investigator criteria.
Trial locations and contacts
30 sites in 3 countries.
30 sites in 3 countries
Spain15 sites
Complejo Hospitalario Universitario A Coruña
A Coruña, Coruña, 15006
Hospital del Mar
Barcelona, Barcelona, 08003
Centre Sociosanitari Sant Jordi de la Vall D'Hebron
Barcelona, Barcelona, 08035
Complejo Asistencial Universitario de Burgos
Burgos, Burgos, 09006
Hospital Universitario Virgen de las Nieves
Granada, Granada, 18014
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28007
Compejo Hospitalario La Paz
Madrid, Madrid, 28046
Hospital Universitario Fundación Alcorcon
Madrid, Madrid, 28922
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, 29010
Hospital Universitario Morales Meseguer
Murcia, Murcia, 3008
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Murcia, 30120
Complejo Asistencial Son Espases
Palma de Mallorca, 07120
Complejo Asistencial Universitario de Salamanca
Salamanca, Salamanca, 37007
Hospital Universitario Virgen del Rocío
Seville, Sevilla, 41013
Hospital Universitario y Pilitécnico La Fe
Valencia, Valencia, 46026
United Kingdom9 sites
University Hospitals Birmingham NHS Foundation Trust
Birmingham
University Hospitals Bristol and Weston NHS Trust
Bristol
Haemophilia and Thrombosis Centre, Kent & Canterbury Hospital, Kent & Canterbury Hospital, Ethelbert Road, Canterbury, CT1 3NG, England, UK
Canterbury
Greater Glasgow and Clyde Health Board
London
Haematology, Royal Victoria Infirmary
Newcastle
Norfolk & Norwich University Hospital Trust
Norwich
Oxford University Hospitals NHS Foundation Trust
Oxford
"Haematology, Derriford Hospital, University Hospitals Plymouth NHS Trust
Plymouth
Torbay and South Devon NHS Foundation Trust
Torquay
Italy6 sites
IRCCS AOU di Bologna, Seràgnoli Institute of Hematology
Bologna
ASST Fatebenefratelli Sacco - Ospedale L. Sacco
Milan
Grande Ospedale Metropolitano Niguarda
Milan
Azienda Ospedaliero-Universitaria Policlinico Umberto I / SAPIENZA Universitá di Roma
Rome
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Rome
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome
About this study
Official title: A Multicentre, Randomized, Open-label Study of Romiplostim Plus Dexamethasone vs Dexamethasone in Patients With Newly Diagnosed Primary Immune Thrombocytopenia
Phase III, open-labeled, randomized and multicenter clinical trial to evaluate the superiority of romiplostim plus dexamethasone vs dexamethasone alone in patients with newly diagnosed primary immune thrombocytopenia
Read the detailed description
The main objective of the study is to evaluate the superiority of romiplostim plus dexamethasone versus dexamethasone alone in the treatment of primary immune thrombocytopenia, with sustained response to any ITP treatment and without World Health Organization grade 2 or higher bleeding, after six months from cessation of treatment.
Maximum time on treatment with romiplostim will be 12 months (365 days). Then, patients will be followed up for 6 additional months (180 days) after stopping romiplostim.
Clinical rules are included if romiplostim dose should be modified or finished. In case of dexamethasone, no dose adjustment is permitted.
The evaluation of romiplastim plus dexamethasone´s superiority in different periods and platelet count, proportion of patients with complete response (CR), global response (GR), early response (ER) and initial response (IR); time to loss of response (LoR), adverse events, quality of life and healthcare resources use are included as secondary objectives.
- Conditions
- Primary Immune Thrombocytopenia
- Being tested
- romiplostim plus dexamethasone, Dexamethasone
- Keywords
- Romiplostim, Dexamethasone
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
romiplostim plus dexamethasoneDrug
Also called ROM + DEX
Patients will be reviewed weekly for 8 weeks (56 days). After Week 8, patients will be reviewed every 2 weeks (14 days) for 8 additional weeks and then monthly until Week 52 (365 days) from randomization.
DexamethasoneDrug
Also called DEX
Patients will be reviewed weekly until the completion of dexamethasone cycles and for a minimum of 8 weeks (56 days). After that, every 2 weeks (14 days) for 8 additional weeks and then monthly until Week 52 (365 days) from randomization.
| Study group | Role | What they receive |
|---|---|---|
| romiplostim plus dexamethasone (ROM + DEX) | Experimental | Dexamethasone 40 mg daily x 4 days only in the first cycle and subcutaneous romiplostim weekly for up to 12 months
Romiplostim:
1. The starting dose should be 3 mcg/kg/week. It could be start during de 4 days of dexamethasone.
2. Patients will weekly receive dose increases of romiplostim in increments of 1 mcg/kg up to a maximum dose of 10 mcg/kg in an attempt to reach a target platelet count higher than 50x109/L.
3. Otherwise, if platelets are lower than 50x109/L treatment with romiplostim will go on until Day 365 since randomization. Receives: Drug: romiplostim plus dexamethasone |
| Dexamethasone (DEX) | Active comparator | Dexamethasone 40 mg daily x 4 days for up to 3 cycles every 14 to 28 days Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving sustain response out of treatment with platelets higher or equal than 30x109/L for 6 months (Sustained Response Off any ITP Treatment)
Proportion of patients with 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 World Health Organization grade 2 or more bleeding
Measured: 180 days after treatment withdrawal
Secondary outcomes (27)
Proportion of patients achieving sustain response out of treatment with platelets higher or equal than 30x109/L for 6 months in the absence of any ITP treatment including any rescue treatment.
Proportion of patients with platelets higher or equal than 30x109/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 World Health Organization grade 2 or more bleeding.
Measured: 180 days after treatment withdrawal
Proportion of patients achieving sustain response out of treatment with platelets higher or equal than 30x109/L for 12 months in the absence of any ITP treatment including any rescue treatment.
Proportion of patients with platelets higher or equal than 30x109/L in the absence of any ITP treatment including any rescue treatment for at least 12 consecutive months (≥365 days) from treatment cessation and without World Health Organization grade 2 or more bleeding.
Measured: 365 days after treatment withdrawal
Proportion of patients achieving sustain response out of treatment with platelets higher or equal than 50x109/L for 12 months in the absence of any ITP treatment including any rescue treatment.
Proportion of patients with platelets higher or equal than 50x109/L in the absence of any ITP treatment including any rescue treatment for at least 12 consecutive months (≥365 days) from treatment cessation and without World Health Organization grade 2 or more bleeding.
Measured: 365 days after treatment withdrawal
Proportion of patients with early response (ER)
Proportion of patients with platelet count higher or equal than 30x109/L and at least double than baseline.
Measured: Day 7
Proportion of patients with initial response (IR)
Proportion of patients with platelet count higher or equal than 30x109/L
Measured: Day 30
Proportion of patients with complete response (CR)
Patients with platelet count ≥100x109/L and absence of bleeding symptoms.
Measured: Day 180, Day 365, Day 545
Proportion of patients with response (R)
Patients with platelet count between 100x109/L and 30x109/L and at least doubled from baseline and absence of bleeding symptoms.
Measured: Day 180, Day 365, Day 545
Proportion of patients with global response (GR)
Patients with platelet count ≥100x109/L and absence of bleeding symptoms or platelet count between 100x109/L and 30x109/L and at least doubled from baseline and absence of bleeding symptoms.
Measured: Day 180, Day 365, Day 545
Proportion of patients with targeted range (TR)
Patients with platelet count between ≥30x109/L and ≤400x109/L.
Measured: Day 180, Day 365, Day 545
Time to loss of response (LoR) in patients who achieved response in both arms.
Number of days from the first time the patient achieved a platelet count ≥30x109/L until platelet count dropped below 30x109/L measured on 2 occasions with more than 1 day apart or presence of bleeding
Measured: In every study visit, assessed up to 545 days
Proportion of patients requiring any rescue treatment
Proportion of patients who need rescue treatments in each arm and total patients
Measured: In every study visit, assessed up to 545 days
Proportion and time to treatment failures
Proportion of patients who need rescue treatments and And the number of days they needed treatment
Measured: In every study visit, assessed up to 545 days
Proportion of patients with adverse events (AEs), including serious adverse events (SAEs) and laboratory safety parameters.
AEs will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Bleeding events will be carefully monitored
Measured: In every study visit, assessed up to 545 days
Changes in patients bleeding
For the assessment of the of the patients' bleeding will be used immune thrombocytopenia-bleeding assessment tool (ITP-BAT): bleeding signs/symptoms are grouped in three domains (skin, visible mucosae and organs) and is graded from 0 (No) to 4.
Measured: Screning, Day 1, Week 8, Week 12, Moth 6, Moth 12 and End of study Visit
Changes in patients' quality of life- Short Form-36 Health Survey
For the assessment of the quality of life during the study will be used Short-Form-36 Health Survey: is a 36-item scale constructed to survey health-related 8 domains: limitations in physical activities due to health problems; limitations in social activities due to physical or emotional problems; limitations unusual role activities due to physical health problems; bodily pain; general mental health (psychological distress and well-being); limitations unusual role activities due to emotional problems; vitality (energy and fatigue); and general health perceptions.
Measured: Day 1, Week 8, Day 180, Day 365 and Day 545
Changes in patients' quality of life- FACIT-F
For the assessment of the quality of life during the study will be used FACIT-F (Fatigue Scale): is a short scale, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week.The level of fatigue is measured by recording item responses ona 4-point Likert scale ranging from 0 "not at all" to 4 "very much.
Measured: Day 1, Week 8, Day 180, Day 365 and Day 545
Changes in patients' quality of life- ITP-Patient Assessment Questionnaire
For the assessment of the quality of life during the study will be used ITP-Patient Assessment Questionnaire): is a disease-specific instrument that was designed to measure the QoL of adult patients with immune thrombocytopenia. The instrument comprises 38 items completed by male respondents and 44 items completed by female respondents.
Measured: Day 1, Week 8, Day 180, Day 365 and Day 545
Healthcare resources use (HRU)
The data collected may be used to conduct exploratory economic analyses and may include:
- Number of outpatient visits,
- Number of home health care
- Number of Hospitalization
- Duration of medical care visits (days)
- Number of Emergency room visits
- Number of diagnostic procedures
- Number of medical care visits
Measured: In every study visit, assessed up to 545 days
Loss of productivity
Number of days of absenteeism from school or work and associated cost
Measured: In every study visit, assessed up to 545 days
Maximum number of consecutive days with platelet response
- The maximum number of consecutive days with platelet count between 100x109/L and 30x109/L in the total sample and in the absence of any rescue treatment
Measured: In every study visit, assessed up to 545 days
Maximum number of consecutive days with platelet complete response (CR)
- The maximum number of consecutive days with platelet count ≥100x109/L in the total sample and in the absence of any rescue treatment
Measured: In every study visit, assessed up to 545 days
Maximum number of consecutive days with platelet global response (GR)
The maximum number of consecutive days with platelet count ≥100x109/L or platelet count between 100x109/L and 30x109/L in the total sample and in the absence of any rescue treatment
Measured: In every study visit, assessed up to 545 days
Maximum number of consecutive days with platelet targeted range (TR)
The maximum number of consecutive days with platelet count between ≥30x109/L and ≤400x109/ L in the total sample and in the absence of any rescue treatment
Measured: In every study visit, assessed up to 545 days
Total number of days with platelet response
The total number od days with platelet count ≥100x109/L in the total sample and in the absence of any rescue treatment
Measured: In every study visit, assessed up to 545 days
Total number of days with platelet complete response (CR)
The total number od days with platelet count ≥100x109/L in the total sample and in the absence of any rescue treatment
Measured: In every study visit, assessed up to 545 days
Total number of days with platelet global response (GR
The total number od days with platelet count ≥100x109/L or platelet count between 100x109/L and 30x109/L in the total sample and in the absence of any rescue treatment
Measured: In every study visit, assessed up to 545 days
Total number of days with platelet targeted range (TR)
The total number od days with platelet count between ≥30x109/L and ≤400x109/ L in the total sample and in the absence of any rescue treatment
Measured: In every study visit, assessed up to 545 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start2 Dec 2022
- Primary completion24 Oct 2026 (estimated)
- Study completion24 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment Randomized 1:1
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlotte Bradbury, Principal investigator, Centre for Trials Research College of Biomedical & Life Sciences Cardiff University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325593
- Sponsor's protocol ID
- RODEX
- Other IDs
- 2024-514147-28-00, 2021-006970-22
- Acronym
- RODEX
- Status last verified
- Jun 2025
- First submitted
- 7 Mar 2022
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results will be shared with the investigators involved in the study, and will be shared when the analysis of the results is performed.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomized, Open-label Study of Romiplostim Plus Dexamethasone vs Dexamethasone in Patients With Newly Diagnosed Primary Immune Thrombocytopenia
- ClinicalTrials.gov ID
- NCT05325593
- Acronym / sponsor ID
- RODEX / RODEX
- Conditions
- Primary Immune Thrombocytopenia
- Keywords
- Romiplostim, Dexamethasone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 24 Oct 2026 (estimated)
- Study completion
- 24 Oct 2026 (estimated)
- First posted
- 13 Apr 2022 (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.
Phase III, open-labeled, randomized and multicenter clinical trial to evaluate the superiority of romiplostim plus dexamethasone vs dexamethasone alone in patients with newly diagnosed primary immune thrombocytopenia
Detailed description
The main objective of the study is to evaluate the superiority of romiplostim plus dexamethasone versus dexamethasone alone in the treatment of primary immune thrombocytopenia, with sustained response to any ITP treatment and without World Health Organization grade 2 or higher bleeding, after six months from cessation of treatment.
Maximum time on treatment with romiplostim will be 12 months (365 days). Then, patients will be followed up for 6 additional months (180 days) after stopping romiplostim.
Clinical rules are included if romiplostim dose should be modified or finished. In case of dexamethasone, no dose adjustment is permitted.
The evaluation of romiplastim plus dexamethasone´s superiority in different periods and platelet count, proportion of patients with complete response (CR), global response (GR), early response (ER) and initial response (IR); time to loss of response (LoR), adverse events, quality of life and healthcare resources use are included as secondary objectives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment Randomized 1:1
| Arm | Type | Receives |
|---|---|---|
| romiplostim plus dexamethasone (ROM + DEX) | Experimental | Drug: romiplostim plus dexamethasoneDexamethasone 40 mg daily x 4 days only in the first cycle and subcutaneous romiplostim weekly for up to 12 months Romiplostim: 1. The starting dose should be 3 mcg/kg/week. It could be start during de 4 days of dexamethasone. 2. Patients will weekly receive dose increases of romiplostim in increments of 1 mcg/kg up to a maximum dose of 10 mcg/kg in an attempt to reach a target platelet count higher than 50x109/L. 3. Otherwise, if platelets are lower than 50x109/L treatment with romiplostim will go on until Day 365 since randomization. |
| Dexamethasone (DEX) | Active comparator | Drug: DexamethasoneDexamethasone 40 mg daily x 4 days for up to 3 cycles every 14 to 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| romiplostim plus dexamethasoneAlso: ROM + DEXPatients will be reviewed weekly for 8 weeks (56 days). After Week 8, patients will be reviewed every 2 weeks (14 days) for 8 additional weeks and then monthly until Week 52 (365 days) from randomization. | Drug | romiplostim plus dexamethasone (ROM + DEX) |
| DexamethasoneAlso: DEXPatients will be reviewed weekly until the completion of dexamethasone cycles and for a minimum of 8 weeks (56 days). After that, every 2 weeks (14 days) for 8 additional weeks and then monthly until Week 52 (365 days) from randomization. | Drug | Dexamethasone (DEX) |
Primary outcome
Proportion of patients achieving sustain response out of treatment with platelets higher or equal than 30x109/L for 6 months (Sustained Response Off any ITP Treatment)
Time frame: 180 days after treatment withdrawal
Proportion of patients with 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 World Health Organization grade 2 or more bleeding
27 secondary outcomes
Proportion of patients achieving sustain response out of treatment with platelets higher or equal than 30x109/L for 6 months in the absence of any ITP treatment including any rescue treatment.
Time frame: 180 days after treatment withdrawal
Proportion of patients achieving sustain response out of treatment with platelets higher or equal than 30x109/L for 12 months in the absence of any ITP treatment including any rescue treatment.
Time frame: 365 days after treatment withdrawal
Proportion of patients achieving sustain response out of treatment with platelets higher or equal than 50x109/L for 12 months in the absence of any ITP treatment including any rescue treatment.
Time frame: 365 days after treatment withdrawal
Proportion of patients with early response (ER)
Time frame: Day 7
Proportion of patients with initial response (IR)
Time frame: Day 30
Proportion of patients with complete response (CR)
Time frame: Day 180, Day 365, Day 545
Proportion of patients with response (R)
Time frame: Day 180, Day 365, Day 545
Proportion of patients with global response (GR)
Time frame: Day 180, Day 365, Day 545
Proportion of patients with targeted range (TR)
Time frame: Day 180, Day 365, Day 545
Time to loss of response (LoR) in patients who achieved response in both arms.
Time frame: In every study visit, assessed up to 545 days
Proportion of patients requiring any rescue treatment
Time frame: In every study visit, assessed up to 545 days
Proportion and time to treatment failures
Time frame: In every study visit, assessed up to 545 days
Proportion of patients with adverse events (AEs), including serious adverse events (SAEs) and laboratory safety parameters.
Time frame: In every study visit, assessed up to 545 days
Changes in patients bleeding
Time frame: Screning, Day 1, Week 8, Week 12, Moth 6, Moth 12 and End of study Visit
Changes in patients' quality of life- Short Form-36 Health Survey
Time frame: Day 1, Week 8, Day 180, Day 365 and Day 545
Changes in patients' quality of life- FACIT-F
Time frame: Day 1, Week 8, Day 180, Day 365 and Day 545
Changes in patients' quality of life- ITP-Patient Assessment Questionnaire
Time frame: Day 1, Week 8, Day 180, Day 365 and Day 545
Healthcare resources use (HRU)
Time frame: In every study visit, assessed up to 545 days
Loss of productivity
Time frame: In every study visit, assessed up to 545 days
Maximum number of consecutive days with platelet response
Time frame: In every study visit, assessed up to 545 days
Maximum number of consecutive days with platelet complete response (CR)
Time frame: In every study visit, assessed up to 545 days
Maximum number of consecutive days with platelet global response (GR)
Time frame: In every study visit, assessed up to 545 days
Maximum number of consecutive days with platelet targeted range (TR)
Time frame: In every study visit, assessed up to 545 days
Total number of days with platelet response
Time frame: In every study visit, assessed up to 545 days
Total number of days with platelet complete response (CR)
Time frame: In every study visit, assessed up to 545 days
Total number of days with platelet global response (GR
Time frame: In every study visit, assessed up to 545 days
Total number of days with platelet targeted range (TR)
Time frame: In every study visit, assessed up to 545 days
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 17 Jun 2025.
- Individual participant dataSharing planned: Yes. The results will be shared with the investigators involved in the study, and will be shared when the analysis of the results is performed.
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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. This study is not recruiting at the moment.
Charlotte Bradbury principal investigator
Centre for Trials Research College of Biomedical & Life Sciences Cardiff University
30 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing romiplostim plus dexamethasone and Dexamethasone in people with Primary Immune Thrombocytopenia, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 30 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Spain, United Kingdom, Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving sustain response out of treatment with platelets higher or equal than 30x109/L for 6 months (Sustained Response Off any ITP Treatment) (time frame: 180 days after treatment withdrawal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2025.