FLIGHT - A multicentre randomised trial of first line treatment pathways for newly diagnosied immune thrombocytopenia patients.

Phase 1

• Conditions: Immune Thrombocytopenia; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2017-001171-23-GB
• Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-26
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

•Patients (males and females) >16 years old with a diagnosis of ITP, a platelet count <30x10^9/L AND a clinical need for first line treatment.
•Patients have provided written informed consent

Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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 to rule out unintended pregnancy
•Contraindications to MMF or steroid 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:
WOMEN: Because of the genotoxic and teratogenic potential of MMF, women of childbearing potential must be willing to use a highly effective method of contraception before and six weeks after stopping MMF (hormonal or barrier method of birth control; abstinence). Contraceptive methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods.

NB: Women are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.

MEN: Sexually active men with female partners that are potentially child bearing are recommended to use condoms during treatment and for at least 90 days after cessation of treatment. Condom use applies for both reproductively competent and vasectomised men, because the risks associated with the transfer of seminal fluid also apply to men who have had a vasectomy. In addition, female partners of male patients treated with MMF are recommended to use highly effective contraception during treatment and for a total of 90 days after the last dose of MMF.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified