To find whether Romiplostim is useful in Aplastic anemia treatment
Phase 3
- Conditions
- Health Condition 1: D619- Aplastic anemia, unspecified
- Registration Number
- CTRI/2023/09/057791
- Lead Sponsor
- Government of Uttar Pradesh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Confirmed cases of Aplastic anemia
2. Patient age >15years
3. Not willing for ASCT and ATG.
4. Non- pregnant women.
5. Those who consent to take part in the study.
6. No hepatic or renal disease.
7. No drug h/o that causes Myelo-suppression.
Exclusion Criteria
1. Previous history of HSCT,
2. Patients eligible for HSCT
3. Patients with HIV/ HCV/ HBV infections.
4. Significant PNH clone and Myelodysplasia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Complete response (CR) defined as—transfusion independent, <br/ ><br>2.Non-responders will be transfusion-dependent <br/ ><br>Timepoint: 3months and 6 months
- Secondary Outcome Measures
Name Time Method 1.Hemoglobin =11 g/dL, Absolute neutrophil count (ANC) more than 1.5 x 10 9 /L and platelet =150 x 10 9 /L; <br/ ><br>2.Partial response (PR) will be those who are transfusion independent, hemoglobin =8 g/dL, ANC more than 0.5 x 10 9 /L and platelet =20 x 10 9 /L <br/ ><br>Timepoint: 3months and 6months