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The PROLONG Trial - Rituximab Maintenance Therapy in ITP

NCT03010202 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2024-05-29

No results posted yet for this study

Summary

This study is a two phase study that aims to evaluate if low-dose Rituximab maintenance therapy may prolong the the effect of Rituximab in immune thrombocytopenia.

Conditions

  • Purpura, Thrombocytopenic, Idiopathic

Interventions

DRUG

Dexamethasone

Comparing the effect of Rituximab infusion With or without Dexamethasone

DRUG

Rituximab

Comparing maintenance dose of 500mg Rituximab at week 1 and week 24 to Placebo

Sponsors & Collaborators

  • Oslo University Hospital

    collaborator OTHER

  • St. Olavs Hospital

    collaborator OTHER

  • Helse Stavanger HF

    collaborator OTHER_GOV

  • University Hospital of North Norway

    collaborator OTHER

  • Haukeland University Hospital

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Centre Hôpital Universitaire Farhat Hached

    collaborator OTHER

  • Henri Mondor University Hospital

    collaborator OTHER

  • University Hospital, Akershus

    collaborator OTHER

  • Cairo University

    collaborator OTHER

  • Ostfold Hospital Trust

    lead OTHER

Principal Investigators

  • Waleed Ghanima, PhD · Ostfold Hospital Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Drugs

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 NCT03010202 on ClinicalTrials.gov