Immune ThrombocytopeniaPhase 3FLIGHTNCT03156452
Newly Diagnosed Immune Thrombocytopenia Testing the Standard Steroid Treatment Against Combined Steroid & Mycophenolate
A Phase 3 study testing Mycophenolate Mofetil and Prednisolone in people with Immune Thrombocytopenia, run by University Hospitals Bristol and Weston NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is a study of two treatment pathways [Standard steroid treatment versus combined steroid and Mycophenolate (MMF)] for subjects with newly diagnosed Immune Thrombocytopenia (ITP). ITP is an illness that causes bruising and bleeding due to a low platelet count (blood cells essential for normal clotting). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Immune Thrombocytopenia
- What is being tested?
- Mycophenolate Mofetil and Prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Oct 2017to 5 Mar 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients (males and females) >16 years old with a diagnosis of ITP, a pl count <30x109/L AND a clinical need for first line treatment.
- Patients have provided written informed consent
Who cannot join
- The exclusion criteria include pregnancy and breastfeeding
- Patients with HIV, Hepatitis B or C, or Common Variable immunodeficiency.
- Women of child bearing potential require a pregnancy test result within 7 days prior to randomisation (as per 7.1 below) to rule out unintended pregnancy
- Contraindications to MMF or steroid (see SPC, Appendix 2) including patients with hypersensitivity to mycophenolate mofetil, mycophenolic acid or to any of the excipients or active significant infection
- Patients not capable of giving informed consent (e.g. due to incapacity)
- Patients unwilling to follow contraceptive advice if allocated to MMF treatment arm.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Bristol NHS Foundation Trust
Bristol, BS2 8ED
About this study
Official title: A Multicentre Randomised Trial of First Line Treatment Pathways for Newly Diagnosed Immune Thrombocytopenia: Standard Steroid Treatment Versus Combined Steroid and Mycophenolate
This is a study of two treatment pathways [Standard steroid treatment versus combined steroid and Mycophenolate (MMF)] for subjects with newly diagnosed Immune Thrombocytopenia (ITP). ITP is an illness that causes bruising and bleeding due to a low platelet count (blood cells essential for normal clotting). Patients are first given high dose steroids but most suffer side effects (e.g. difficulty sleeping, weight gain, moods swings, high blood pressure and diabetes). In addition, the majority of patients become ill again when the steroids are stopped - only about 20% stay well long term. ITP is relatively rare, non-cancerous in nature and the rare impact on survival of ITP have prevented it from being a priority for research funding, with first line treatment being unsatisfactory and unchallenged for decades. This underestimates the profound adverse impact an ITP diagnosis and its treatment has on individual patients, many of whom are young.
MMF is often used as the next stage treatment for ITP and it works well. However, it can take up to 2 months to work during which patients continue to be at risk of bleeding, bruising, fatigue and usually need more steroids which they find intolerable. They are required to come to hospital for weekly blood tests and for many this impacts on work. We want to find out whether it would benefit more patients if everyone takes MMF at diagnosis instead of current practice (waiting for the illness to come back). We plan to test this by comparing the current way we treat patients to a new way with patients given MMF right at the start of their treatment. 120 patients from 20 different hospitals will be asked to take part and half will be randomly chosen for the new pathway.
Read the detailed description
This is a multicentre, randomised clinical trial of MMF with steroid as a first line treatment for participants with ITP against the standard care pathway involving steroids alone as first line treatment. This is not a blinded study, therefore patients and research team will know which treatment arm the participant will be randomised to.
There are no additional appointments or separate trial visits for this trial. Participants will be seen at their usual hospital appointments, which may take slightly longer than they do usually to gather all the information needed to carefully record information for the trial and to see how the participants are.
Participants will be screened and given up to one week of steroid prior to randomisation to enable sufficient time to read information, discuss and ask questions with informed consent in an appropriate setting.
Participants will then be randomised to one of either two treatment pathways below and be asked to complete quality of life questionnaires:
- Steroid +MMF pathway: 1mg/kg once daily prednisolone 4 days (maximum of 100mg), 40mg once daily 2 weeks, 20mg once daily 2 weeks, 10mg once daily 2 weeks, 5mg once daily 2 weeks then 5mg alternate days 2 weeks then stop, (Dexamethasone 20mg or 40mg daily for 4 days is an alternative option to prednisolone if deemed clinically more appropriate for individual circumstances). For the duration of steroid, patients will get a PPI (proton pump inhibitors) or H2 antagonist to protect against gastric bleeding and appropriate bone protection. From randomisation (alongside steroid), MMF 500mg twice daily starting dose then increased to 750mg twice daily after 2 weeks if tolerated and 1g twice daily after another 2 weeks if tolerated (4 weeks after starting). After 6 months of MMF therapy, all patients who have remained in complete remission (platelet count> 100 x10 9/L) will reduce the dose by 250mg (one capsule) each month. The aim is to continue on the lowest dose that achieves a haemostatic (safe) platelet count (platelet 50-100 x10 9/L) and to ensure that patients who have gone into a spontaneous remission do not continue to take the drug indefinitely.
- Steroid only group: 1mg/kg once daily prednisolone 4 days (maximum of 100mg), 40mg once daily 2 weeks, 20mg once daily 2 weeks, 10mg once daily 2 weeks, 5mg once daily 2 weeks then 5mg alternate days 2 weeks then stop (Dexamethasone 20mg or 40mg orally daily for 4 days is an alternative option to prednisolone if deemed clinically more appropriate for individual circumstances).
For the duration of steroid, patients will get a PPI (proton pump inhibitors) or H2 antagonist to protect against gastric bleeding and appropriate bone protection.
Patients will be seen at the following time points after randomisation:
2 months, 4 months, 6 months and 12 months when the following procedures will take place:
- Laboratory tests (safety bloods)
- Date of treatment failure (refractory or relapse AND need for second line therapy). [If treatment failure occurs, choice of second line treatment will be individualised according to patient's clinical circumstances. Further steroid will be given according to clinical need. Hospital monitoring of platelet levels is part of routine care for ITP patients and we will collect these details from the medical notes without requiring patients to come in for additional samples to be taken. These locally collected samples may be collected monthly (or less often) for patients believed to be in stable remission and weekly at lower or declining platelet levels. We expect this to allow us to calculate the time in remission and time in relapse with reasonable accuracy over the 12 month follow up period].
- Vital signs
- Blood sugar results
- Medication side effects (including infections)
- Dose and duration of steroids
- Need for rescue or other treatments (including second or third line). [Emergency and rescue treatments will be permitted throughout the study. These include platelet transfusions, tranexamic acid and intravenous immunoglobulin. These are known not to impact on the natural history of ITP and it is recognised that they may be important for patient safety. The use of 'rescue treatments' will be recorded on the CRF]
- Hospital attendances or admissions
- Days off work
- Patient questionnaires: Quality of life assessment
- Immunoglobulins rechecked at 6 months and 12 months
In addition at Screening and 2 months, participants will have the option to give an extra blood sample for the Bristol Biobank (ancillary translational basic science studies). There is an additional patient information sheet and consent form for this. Participants can consent to enter the trial, but decline to have bloods taken for bio banking.
In addition at 6 and 12 months, immunoglobulins will be checked.
- Conditions
- Immune Thrombocytopenia
- Being tested
- Mycophenolate Mofetil, Prednisolone
- 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.
500 mg and 250mg tablets for oral administration
PrednisoloneDrug
Also called Steroid
5mg tablets for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Steroid & Mycophenolate mofetil 1st line | Experimental | Mycophenolate mofetil: 1 gm bd Non-IMP Steroid: 1mg/kg od 4 days (maximum of 100mg), 40mg od 2 weeks, 20mg od 2 weeks, 10mg od 2 weeks, 5mg od 2 weeks then 5mg alternate days 2 weeks. Receives: Drug: Mycophenolate Mofetil |
| Prednisolone (Steroid) alone 1st line | Active comparator | Non-IMP steroid: 1mg/kg od 4 days (maximum of 100mg), 40mg od 2 weeks, 20mg od 2 weeks, 10mg od 2 weeks, 5mg od 2 weeks then 5mg alternate days 2 weeks. Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from randomisation to treatment failure.
To include patients who are refractory (platelet count <30x109/L in spite of 2 weeks treatment in the steroid arm or platelet count <30x109/L in spite of 2 months treatment in the steroid +MMF arm) or who initially respond but then relapse (defined clinically as platelet count <30x109/L and need for further therapy).
Measured: 1 year
Secondary outcomes (12)
Medication side effects, toxicity and other adverse events (including infection episodes)
Most participants experience side effects from the medication, data will be collected on treatment side effects and adverse events as assessed by CTCAE V4.0
Measured: Up to 12 months post randomisation
Bleeding events
To be analysed as number of bleeding events per patient recorded by 12 months. In addition we will collect site and type of bleeding, treatment required for bleeding, whether hospital admission was required, whether ITP rescue treatments were needed to be used in the calculating of costs for the economic evaluation.
Measured: up to 12 months post randomisation
Remission rates
Platelet count >30 x109/L and at least 2 fold increase from baseline. Complete >100x10 9/L, partial 30-100x10 9/L
Measured: Up to 12 months post randomisation
Time to relapse and time to next therapy
period of time between relapse and time of next therapy
Measured: Up to 12 months post randomisation
Cumulative cortiocosteroid dose
Total steroid dose from randomisation
Measured: Up to 12 months post randomisation
Need for rescue therapies
To be analysed as number patients who required rescue therapies between randomisation and 12 months post randomisation. We will also record the mean number of rescue therapies, why they were needed their type and cost for use in the economic evaluation.
Measured: up to 12 months post randomisation
Need for splenectomy
Whether a participant has undergone splenectomy procedure
Measured: Up to 12 months post randomisation
Socioeconomic costs
NHS, personal and social costs
Measured: Up to 12 months post randomisation
Patient reported outcomes - Quality of Life
To be assessed using the utility score of the ICECAP (A) to calculate area under the curve using the trapezium method over a 12 month time frame from date of randomisation.
Measured: Up to 12 months post randomisation
Patient reported outcomes - Fatigue
To be assessed using the utility score of the FACIT-F (Version 4) to calculate area under the curve over a 12 month time frame from date of randomisation.
Measured: Up to 12 months post randomisation
Patient reported outcomes - Impact of bleeding
To be assessed using the utility score of the FACT-Th6 (Version 4) to calculate area under the curve over a 12 month time frame from date of randomisation.
Measured: Up to 12 months post randomisation
Patient reported outcomes - Care Costs
To be assessed using the utility score of the Thrombocytopenia care costs V1 questionnaire to calculate area under the curve over a 12 month time frame from date of randomisation.
Measured: Up to 12 months post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start25 Oct 2017
- Primary completion5 Mar 2020
- Study completion5 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- A multicentre, open label randomised clinical trial of MMF with steroid as a first line treatment for patients with ITP against the standard care pathway involving steroids alone as first line treatment.
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Bristol and Weston NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiff University
- Responsible party
- Sponsor
- Investigators
- Charlotte Bradbury, Study director, University of Bristol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156452
- Sponsor's protocol ID
- ON/2016/6004
- Other IDs
- 2017-001171-23, PB-PG-0815-20016, 2017
- Acronym
- FLIGHT
- Status last verified
- Oct 2022
- First submitted
- 2 May 2017
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stimpson ML, Wolf J, Charbit B, Williams EL, Lait PJP, Schewitz-Bowers LP, Lee RWJ, Bradbury CA. Systemic immunosuppression depletes peripheral blood regulatory B cells in patients with immune thrombocytopenia. Br J Haematol. 2024 Feb;204(2):644-648. doi: 10.1111/bjh.19144. Epub 2023 Oct 12.
PubMed 37823469Bradbury CA, Pell J, Hill Q, Bagot C, Cooper N, Ingram J, Breheny K, Kandiyali R, Rayment R, Evans G, Talks K, Thomas I, Greenwood R. Mycophenolate Mofetil for First-Line Treatment of Immune Thrombocytopenia. N Engl J Med. 2021 Sep 2;385(10):885-895. doi: 10.1056/NEJMoa2100596.
PubMed 34469646Pell J, Greenwood R, Ingram J, Wale K, Thomas I, Kandiyali R, Mumford A, Dick A, Bagot C, Cooper N, Hill Q, Bradbury CA. Trial protocol: a multicentre randomised trial of first-line treatment pathways for newly diagnosed immune thrombocytopenia: standard steroid treatment versus combined steroid and mycophenolate. The FLIGHT trial. BMJ Open. 2018 Oct 18;8(10):e024427. doi: 10.1136/bmjopen-2018-024427.
PubMed 30341143
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Randomised Trial of First Line Treatment Pathways for Newly Diagnosed Immune Thrombocytopenia: Standard Steroid Treatment Versus Combined Steroid and Mycophenolate
- ClinicalTrials.gov ID
- NCT03156452
- Acronym / sponsor ID
- FLIGHT / ON/2016/6004
- Conditions
- Immune Thrombocytopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University Hospitals Bristol and Weston NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Cardiff University
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 17 May 2017 (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 study of two treatment pathways [Standard steroid treatment versus combined steroid and Mycophenolate (MMF)] for subjects with newly diagnosed Immune Thrombocytopenia (ITP). ITP is an illness that causes bruising and bleeding due to a low platelet count (blood cells essential for normal clotting). Patients are first given high dose steroids but most suffer side effects (e.g. difficulty sleeping, weight gain, moods swings, high blood pressure and diabetes). In addition, the majority of patients become ill again when the steroids are stopped - only about 20% stay well long term. ITP is relatively rare, non-cancerous in nature and the rare impact on survival of ITP have prevented it from being a priority for research funding, with first line treatment being unsatisfactory and unchallenged for decades. This underestimates the profound adverse impact an ITP diagnosis and its treatment has on individual patients, many of whom are young.
MMF is often used as the next stage treatment for ITP and it works well. However, it can take up to 2 months to work during which patients continue to be at risk of bleeding, bruising, fatigue and usually need more steroids which they find intolerable. They are required to come to hospital for weekly blood tests and for many this impacts on work. We want to find out whether it would benefit more patients if everyone takes MMF at diagnosis instead of current practice (waiting for the illness to come back). We plan to test this by comparing the current way we treat patients to a new way with patients given MMF right at the start of their treatment. 120 patients from 20 different hospitals will be asked to take part and half will be randomly chosen for the new pathway.
Detailed description
This is a multicentre, randomised clinical trial of MMF with steroid as a first line treatment for participants with ITP against the standard care pathway involving steroids alone as first line treatment. This is not a blinded study, therefore patients and research team will know which treatment arm the participant will be randomised to.
There are no additional appointments or separate trial visits for this trial. Participants will be seen at their usual hospital appointments, which may take slightly longer than they do usually to gather all the information needed to carefully record information for the trial and to see how the participants are.
Participants will be screened and given up to one week of steroid prior to randomisation to enable sufficient time to read information, discuss and ask questions with informed consent in an appropriate setting.
Participants will then be randomised to one of either two treatment pathways below and be asked to complete quality of life questionnaires:
- Steroid +MMF pathway: 1mg/kg once daily prednisolone 4 days (maximum of 100mg), 40mg once daily 2 weeks, 20mg once daily 2 weeks, 10mg once daily 2 weeks, 5mg once daily 2 weeks then 5mg alternate days 2 weeks then stop, (Dexamethasone 20mg or 40mg daily for 4 days is an alternative option to prednisolone if deemed clinically more appropriate for individual circumstances). For the duration of steroid, patients will get a PPI (proton pump inhibitors) or H2 antagonist to protect against gastric bleeding and appropriate bone protection. From randomisation (alongside steroid), MMF 500mg twice daily starting dose then increased to 750mg twice daily after 2 weeks if tolerated and 1g twice daily after another 2 weeks if tolerated (4 weeks after starting). After 6 months of MMF therapy, all patients who have remained in complete remission (platelet count> 100 x10 9/L) will reduce the dose by 250mg (one capsule) each month. The aim is to continue on the lowest dose that achieves a haemostatic (safe) platelet count (platelet 50-100 x10 9/L) and to ensure that patients who have gone into a spontaneous remission do not continue to take the drug indefinitely.
- Steroid only group: 1mg/kg once daily prednisolone 4 days (maximum of 100mg), 40mg once daily 2 weeks, 20mg once daily 2 weeks, 10mg once daily 2 weeks, 5mg once daily 2 weeks then 5mg alternate days 2 weeks then stop (Dexamethasone 20mg or 40mg orally daily for 4 days is an alternative option to prednisolone if deemed clinically more appropriate for individual circumstances).
For the duration of steroid, patients will get a PPI (proton pump inhibitors) or H2 antagonist to protect against gastric bleeding and appropriate bone protection.
Patients will be seen at the following time points after randomisation:
2 months, 4 months, 6 months and 12 months when the following procedures will take place:
- Laboratory tests (safety bloods)
- Date of treatment failure (refractory or relapse AND need for second line therapy). [If treatment failure occurs, choice of second line treatment will be individualised according to patient's clinical circumstances. Further steroid will be given according to clinical need. Hospital monitoring of platelet levels is part of routine care for ITP patients and we will collect these details from the medical notes without requiring patients to come in for additional samples to be taken. These locally collected samples may be collected monthly (or less often) for patients believed to be in stable remission and weekly at lower or declining platelet levels. We expect this to allow us to calculate the time in remission and time in relapse with reasonable accuracy over the 12 month follow up period].
- Vital signs
- Blood sugar results
- Medication side effects (including infections)
- Dose and duration of steroids
- Need for rescue or other treatments (including second or third line). [Emergency and rescue treatments will be permitted throughout the study. These include platelet transfusions, tranexamic acid and intravenous immunoglobulin. These are known not to impact on the natural history of ITP and it is recognised that they may be important for patient safety. The use of 'rescue treatments' will be recorded on the CRF]
- Hospital attendances or admissions
- Days off work
- Patient questionnaires: Quality of life assessment
- Immunoglobulins rechecked at 6 months and 12 months
In addition at Screening and 2 months, participants will have the option to give an extra blood sample for the Bristol Biobank (ancillary translational basic science studies). There is an additional patient information sheet and consent form for this. Participants can consent to enter the trial, but decline to have bloods taken for bio banking.
In addition at 6 and 12 months, immunoglobulins will be checked.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A multicentre, open label randomised clinical trial of MMF with steroid as a first line treatment for patients with ITP against the standard care pathway involving steroids alone as first line treatment.
| Arm | Type | Receives |
|---|---|---|
| Steroid & Mycophenolate mofetil 1st line | Experimental | Drug: Mycophenolate MofetilMycophenolate mofetil: 1 gm bd Non-IMP Steroid: 1mg/kg od 4 days (maximum of 100mg), 40mg od 2 weeks, 20mg od 2 weeks, 10mg od 2 weeks, 5mg od 2 weeks then 5mg alternate days 2 weeks. |
| Prednisolone (Steroid) alone 1st line | Active comparator | Drug: PrednisoloneNon-IMP steroid: 1mg/kg od 4 days (maximum of 100mg), 40mg od 2 weeks, 20mg od 2 weeks, 10mg od 2 weeks, 5mg od 2 weeks then 5mg alternate days 2 weeks. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients (males and females) >16 years old with a diagnosis of ITP, a pl count <30x109/L AND a clinical need for first line treatment.
- Patients have provided written informed consent
Key exclusion criteria (6 listed)
- The exclusion criteria include pregnancy and breastfeeding
- Patients with HIV, Hepatitis B or C, or Common Variable immunodeficiency.
- Women of child bearing potential require a pregnancy test result within 7 days prior to randomisation (as per 7.1 below) to rule out unintended pregnancy
- Contraindications to MMF or steroid (see SPC, Appendix 2) including patients with hypersensitivity to mycophenolate mofetil, mycophenolic acid or to any of the excipients or active significant infection
- Patients not capable of giving informed consent (e.g. due to incapacity)
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 |
|---|---|---|
| Mycophenolate Mofetil500 mg and 250mg tablets for oral administration | Drug | Steroid & Mycophenolate mofetil 1st line |
| PrednisoloneAlso: Steroid5mg tablets for oral administration | Drug | Prednisolone (Steroid) alone 1st line |
Primary outcome
Time from randomisation to treatment failure.
Time frame: 1 year
To include patients who are refractory (platelet count <30x109/L in spite of 2 weeks treatment in the steroid arm or platelet count <30x109/L in spite of 2 months treatment in the steroid +MMF arm) or who initially respond but then relapse (defined clinically as platelet count <30x109/L and need for further therapy).
12 secondary outcomes
Medication side effects, toxicity and other adverse events (including infection episodes)
Time frame: Up to 12 months post randomisation
Bleeding events
Time frame: up to 12 months post randomisation
Remission rates
Time frame: Up to 12 months post randomisation
Time to relapse and time to next therapy
Time frame: Up to 12 months post randomisation
Cumulative cortiocosteroid dose
Time frame: Up to 12 months post randomisation
Need for rescue therapies
Time frame: up to 12 months post randomisation
Need for splenectomy
Time frame: Up to 12 months post randomisation
Socioeconomic costs
Time frame: Up to 12 months post randomisation
Patient reported outcomes - Quality of Life
Time frame: Up to 12 months post randomisation
Patient reported outcomes - Fatigue
Time frame: Up to 12 months post randomisation
Patient reported outcomes - Impact of bleeding
Time frame: Up to 12 months post randomisation
Patient reported outcomes - Care Costs
Time frame: Up to 12 months post randomisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Derived from this study: PubMed 37823469Stimpson ML, Wolf J, Charbit B, Williams EL, Lait PJP, Schewitz-Bowers LP, Lee RWJ, Bradbury CA. Systemic immunosuppression depletes peripheral blood regulatory B cells in patients with immune thrombocytopenia. Br J Haematol. 2024 Feb;204(2):644-648. doi: 10.1111/bjh.19144. Epub 2023 Oct 12.
- Derived from this study: PubMed 34469646Bradbury CA, Pell J, Hill Q, Bagot C, Cooper N, Ingram J, Breheny K, Kandiyali R, Rayment R, Evans G, Talks K, Thomas I, Greenwood R. Mycophenolate Mofetil for First-Line Treatment of Immune Thrombocytopenia. N Engl J Med. 2021 Sep 2;385(10):885-895. doi: 10.1056/NEJMoa2100596.
- Derived from this study: PubMed 30341143Pell J, Greenwood R, Ingram J, Wale K, Thomas I, Kandiyali R, Mumford A, Dick A, Bagot C, Cooper N, Hill Q, Bradbury CA. Trial protocol: a multicentre randomised trial of first-line treatment pathways for newly diagnosed immune thrombocytopenia: standard steroid treatment versus combined steroid and mycophenolate. The FLIGHT trial. BMJ Open. 2018 Oct 18;8(10):e024427. doi: 10.1136/bmjopen-2018-024427.
- Individual participant dataSharing planned: No
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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 study director
University of Bristol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mycophenolate Mofetil and Prednisolone in people with Immune Thrombocytopenia, run by University Hospitals Bristol and Weston NHS Foundation Trust at 1 site in United Kingdom.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 26 Oct 2022. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time from randomisation to treatment failure. (time frame: 1 year). 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 NCT03156452, which also lists 3 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 26 Oct 2022; AzTrials last refreshed its copy on 7 Nov 2026.