Elective rituximab in TTP

Phase 1

• Conditions: Acquired thrombotic thrombocytopenic purpura; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2017-001117-86-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-18
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

1. Male or female, age>18
2.Antibody-mediated TTP with at least one previous acute TTP episode
3.ADAMTS13 activity dropping to =15% documented on 2 separate occasions on different days, , with platelets>150 and no evidence of microangiopathic haemolytic anaemia and LDH <1.5 x upper limit normal
4.Females of childbearing potential and males agree to use an effective method of contraception from the time consent is signed for 12 months after treatment completion. Effective methods of contraception acceptable for this trial are oral, implanted or injected hormonal methods of contraception, IUD or IUS, and barrier methods of contraception
5.Females of childbearing potential have a negative pregnancy test within 7 days prior to being randomised. Participants 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
6.Willing and able to provide written informed consent.
7. Willing and able to comply with the trial protocol

Are the trial subjects under 18? no
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 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

1. Females who are pregnant, planning pregnancy or breastfeeding
2. Concurrent and/or recent involvement in other research that is likely to interfere with the intervention within 3 months of study enrolment
3. Known allergies to rituximab
4. Patients currently undergoing plasma infusion/exchange
5. Patients on therapy with other immunosuppressive medication (except steroids)
6. Patients with a current acute severe infection or a history of recurring or chronic infections or underlying conditions which may further predispose patient to serious infection.

Study & Design

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