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NCT Number: NCT06288932

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

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.

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Key information

Conditions

Immune Thrombocytopenia Purpura

Age range

5 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Institute of Blood Diseases and Bone Marrow Transplantation

Karachi, Sindh, 75300, Pakistan

About this study

Immune Thrombocytopenia Purpura (ITP) is an acquired, immune-mediated disorder characterized by a severe decrease in peripheral thrombocyte count to less than 100 x 10⁹/L, leading to mucocutaneous bleeding. Our primary objective is to evaluate the efficacy of adding Mycophenolate Mofetil (MMF) alongside steroids in the first-line treatment of ITP, aiming for an enhanced therapeutic response, lower risk of refractory and chronic ITP, reduced financial burden, and improved overall outcomes.

The study aims to validate the efficacy and safety of MMF as a first-line treatment option for ITP while reducing the economic burden and risk of relapse associated with the condition

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion Requirements:

  • Age: 5-60 years • Number of plates: <30x109

Exclusion Standards:

Pregnancy; lactation; hepatitis B and C; HIV-reactive individuals; and medication allergies

Treatment and study plan

Mycophenolate Mofetil (MMF) Treatment

Drug

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.

Other names: Suprimun

Primary outcomes

  1. Platelet count monitoring

    Time frame: assessed after 3 months and 6 months of treatment.

    Platelet count improvement, as assessed through regular monitoring and according to response criteria:

    The response criteria to the treatment described as follow:

    • Complete response: Platelet count ≥ 100 x 10^ 9 /L
    • Partial response: Platelet count 30≥ 100 x 10 ^9 /L
    • No response: Platelet count 30 x 10^9 /

Secondary outcomes

  1. Assessment of Health-Related Quality of Life questionnaire

    Time frame: 12 months

    Health-related quality of life questionnaire

  2. Incidence of adverse events

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

An Outcome Study of Conventional Steroids Vs. Steroids Combined with Mycophenolate for the Management of Newly Diagnosed Immune Thrombocytopenia Purpura: a Cost Effective Measure in Developing Nations.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 1, 2024
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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