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Outcome Study of Conventional Steroids Vs. Steroids Combined with Mycopehnolate in Newly Diagnosed Immune Thrombocytopenia Purpura.

NCT06288932 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2024-11-06

No results posted yet for this study

Summary

Immune thrombocytopenia Purpura (ITP) is an autoimmune condition delineated by humoral as well as cell mediated immune response against thrombocyte surface proteins GPIIb/IIIa receptors, affecting primary homeostasis leading to mucocutaneous bleeding.ITP is characterized by platelet count \<100 x 109/L. The conventional line of treatment for newly diagnosed ITP is steroids but significant disadvantages have been associated with long term use and a high risk of relapse when reducing the dose. The addition of MMF to the first line treatment of ITP resulted in substantial response and a lower risk of refractory ITP with decreased financial burden and improved outcome.

Conditions

  • Immune Thrombocytopenia Purpura

Interventions

DRUG

Mycophenolate Mofetil (MMF) Treatment

The first-line treatment of immune thrombocytopenia purpura with Mycophenolate Mofetil produced a significant response, a lowered likelihood of refractory ITP, a better outcome, and less financial burden.

Sponsors & Collaborators

  • National Institute of Blood and Marrow Transplant (NIBMT), Pakistan

    lead OTHER_GOV

Principal Investigators

  • Rukh-e- Zainub, Pharm-D,Mphil(enrolled) · National Institute of Blood Diseases and Bone Marrow Transplantation

  • Shafaq Abdul Samad, MBBS,FCPS · National Institute of Blood Diseases and Bone Marrow Transplantation

  • Dr.Iyad Naeem, Ph.D · KARACHI UNIVERSITY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-18
Primary Completion
2024-02-18
Completion
2024-08-18

Countries

  • Pakistan

Study Locations

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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 NCT06288932 on ClinicalTrials.gov