study of Romiplostim in patients with aplastic anemia

A Phase IIB study to see if addition of Romiplostim to Antithymocyte globulin (ATG) and Cyclosporine (CSA) will improve overall response rates in patients with severe aplastic anemia [ACRA study] - ACRA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/02/031223

Enrollment

105

Registered

2021-02-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D612- Aplastic anemia due to other external agents

Interventions

Intervention1: Romiplostim: COHORT 2 â?? Romiplostim 10 ug/kg weekly starting Day 1 for 6 months Intervention2: Romiplostim: COHORT 3 â?? Romiplostim 10 ug/kg weekly [esc dose] starting Day 1 for 6 mo

Eligibility

Inclusion criteria

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 [ 3. Should have negative chromosomal breakage analysis studies

Exclusion criteria

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 4.Patients with diagnosis of Non-severe aplastic anemia

Design outcomes

Primary

Measure	Time frame
A Phase IIB randomized trial to study if the addition of weekly Romiplostim will improve the 6-month overall response rates in patients with severe aplastic anemia receiving immunosuppressive therapy with Anti-thymocyte globulin (ATG) and CyclosporineTimepoint: 6 months	—

Secondary

Measure	Time frame
1. To study 2 different methods of Romiplostim administration to see which method produces higher and durable response rates 2.To study the tolerability and adverse events associated with using subcutaneous Romiplostim 3. To study the incidence of relapse, clonal evolution and marrow fibrosis in patients who receive RomiplostimTimepoint: 6 months	—

Countries

India

Contacts

Public ContactBiju George

Christian Medical College

biju@cmcvellore.ac.in04162282169

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026