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Trial record 34 of 554 for:    Thrombocytopenia: Clinical Trials

Newly Diagnosed Immune Thrombocytopenia Testing the Standard Steroid Treatment Against Combined Steroid & Mycophenolate (FLIGHT)

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ClinicalTrials.gov Identifier: NCT03156452
Recruitment Status : Not yet recruiting
First Posted : May 17, 2017
Last Update Posted : May 18, 2017
Sponsor:
Collaborator:
Cardiff University
Information provided by (Responsible Party):
University Hospitals Bristol NHS Foundation Trust

Brief 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). 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.


Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Drug: Mycophenolate Mofetil Drug: Prednisolone Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: A Multicentre Randomised Trial of First Line Treatment Pathways for Newly Diagnosed Immune Thrombocytopenia: Standard Steroid Treatment Versus Combined Steroid and Mycophenolate
Estimated Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2020


Arm Intervention/treatment
Experimental: Steroid & Mycophenolate mofetil 1st line
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.
Drug: Mycophenolate Mofetil
500 mg and 250mg tablets for oral administration

Active Comparator: Prednisolone (Steroid) alone 1st line
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.
Drug: Prednisolone
5mg tablets for oral administration
Other Name: Steroid




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Remission rates [ Time Frame: Up to 12 months post randomisation ]
    Platelet count >30 x109/L and at least 2 fold increase from baseline. Complete >100x10 9/L, partial 30-100x10 9/L

  2. Time to next therapy [ Time Frame: Up to 12 months post randomisation ]
    Clinically relapse (as platelet count <30x109/L) and need for further therapy



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03156452


Contacts
Contact: Julie C Pell 07894498380 pelljc@cardiff.ac.uk
Contact: Katharine Wale 0117 342 0231 ResearchApprovals@UHBristol.nhs.uk

Sponsors and Collaborators
University Hospitals Bristol NHS Foundation Trust
Cardiff University
Investigators
Study Director: Charlotte Bradbury University of Bristol

Responsible Party: University Hospitals Bristol NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03156452     History of Changes
Other Study ID Numbers: ON/2016/6004
2017-001171-23 ( EudraCT Number )
PB-PG-0815-20016 ( Other Grant/Funding Number: National Institute for Health Research (NIHR) )
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Mycophenolic Acid
Prednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors