Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mycophenolate Mofetil (MMF) Treatment | Experimental | Patients in this arm will receive Mycophenolate Mofetil (MMF) at a starting dose of 500mg twice daily along with Prednisolone. The pediatric dose of MMF will be calculated by 30mg/kg/day. Dose adjustment will be based on treatment response, with potential increases to 750mg twice daily or 1g twice daily. MMF will be administered for a specific duration, as determined by the study design. |
|
| Standard Treatment Control | No Intervention | Patients in this arm will receive the standard treatment for ITP, which may include corticosteroids (prednisolone) commonly used for ITP management.The treatment regimen will be determined based on current standard guidelines and clinical practice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet count monitoring | Platelet count improvement, as assessed through regular monitoring and according to response criteria: The response criteria to the treatment described as follow:
| assessed after 3 months and 6 months of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Health-Related Quality of Life questionnaire | Health-related quality of life questionnaire | 12 months |
| Incidence of adverse events | 12 months |
Not provided
Inclusion Requirements:
• Age: 5-60 years • Number of plates: <30x109
Exclusion Standards:
Pregnancy; lactation; hepatitis B and C; HIV-reactive individuals; and medication allergies
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rukh-e- Zainub, Pharm-D,Mphil(enrolled) | National Institute of Blood Diseases and Bone Marrow Transplantation | Principal Investigator |
| Shafaq Abdul Samad, MBBS,FCPS | National Institute of Blood Diseases and Bone Marrow Transplantation | Study Director |
| Dr.Iyad Naeem, Ph.D | KARACHI UNIVERSITY | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Blood Diseases and Bone Marrow Transplantation | Karachi | Sindh | 75300 | Pakistan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study will comprise the newly diagnosed patients of Immune thrombocytopenia purpura aged 5-60 year. Patients will with a 1:1 ratio among the two group.
Not provided
Not provided
Not provided
Not provided
|
| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
Not provided
Not provided