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

NCT03156452 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2022-10-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Mycophenolate Mofetil

500 mg and 250mg tablets for oral administration

DRUG

Prednisolone

5mg tablets for oral administration

Sponsors & Collaborators

  • Cardiff University

    collaborator OTHER

  • University Hospitals Bristol and Weston NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Charlotte Bradbury · University of Bristol

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-25
Primary Completion
2020-03-05
Completion
2020-03-05

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03156452 on ClinicalTrials.gov