study of Romiplostim in patients with aplastic anemia
Phase 2
- Conditions
- Health Condition 1: D612- Aplastic anemia due to other external agents
- Registration Number
- CTRI/2021/02/031223
- Lead Sponsor
- Christian Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Adult patients > 15 years of age with the diagnosis of Severe (SAA) or Very Severe aplastic anemia (VSAA) as per standard diagnostic criteria
2. Should have normal renal and liver functions [ < 2 times ULN]
3. Should have negative chromosomal breakage analysis studies
Exclusion Criteria
1.No active infection/febrile episode for at least 2 weeks prior to initiation of ATG therapy
2.Morphological features suggestive of Fanconi anemia or Dyskeratosis congenita
3.Children with aplastic anemia < 15 years of age
4.Patients with diagnosis of Non-severe aplastic anemia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method