EUCTR2015-005276-14-DK
Active, not recruiting
Phase 1
Prolonging the response by low-dose Rituximab maintenance therapy in immune thrombocytopenia: a randomized placebo-controlled trial- the PROLONG trial. - PROLONG-trial
Sykehuset Østfold HF0 sites130 target enrollmentOctober 19, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sykehuset Østfold HF
- Enrollment
- 130
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •First randomization (Induction phase)
- •1\. Male or female aged \=18 years.
- •2\. Diagnosis of primary ITP of less than one\-year duration and having a platelet count of \= 30 x109/L measured within 4 weeks prior to inclusion with failure to achieve response or relapse after one or more cycles of dexamethasone (40 mg daily for 4 days) or after at least 3 weeks under any other steroid (prednisone or prednisolone). Platelet count between 31 to 50 x109/L is accepted if higher platelet count is required due to concomitant antiplatelet therapy or bleeding.
- •3\. Scheduled intravenous treatment of rituximab.
- •4\. Rituximab infusion will be more than 2 weeks after the first injection of an anti\-COVID\-19 vaccine.
- •5\. Signed and dated written informed consent.
- •6\. Females of child\-bearing potential accepting to follow effective contraceptive methods for at least 12 months following the last administration of rituximab or placebo.
- •Second randomization (maintenance phase)
- •7\. Completion of the induction phase (phase 1\) of the study.
- •8\. Sustained response at the end of phase 1\.
Exclusion Criteria
- •First randomization (Induction phase)
- •1\. Previous treatment for ITP with: rituximab, other immune suppressants (including mycophenolate mofetil, azathioprin, cyclosporine), dapsone, danazol, thrombopoietin receptor agonist, chemotherapy or splenectomy.
- •2\. Anti\-COVID\-19 unvaccinated patient with at least one of the following characteristics:
- •a. \=65 years old
- •c. Diagnosed Arterial hypertension
- •d. Diagnosed Diabetes mellitus
- •e. Known Kidney disease
- •f. Known Lung disease
- •3\. Pregnancy or lactation.
- •4\. Known active gastro\-duodenal ulcer.
Outcomes
Primary Outcomes
Not specified
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