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A trial to study infection reduction potential of Pegfilgrastim medicine in aplastic anemia patients

Study of efficacy of pegfilgrsstim in reducing infections in aplastic anemia patients receiving immunosuppressive therapy-An open label randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/059955
Enrollment
80
Registered
2023-11-17
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: D613- Idiopathic aplastic anemia

Interventions

Intervention1: PEGFILGRASTIM: ADMINISTRATION OF single dose of PEGFILGRASTIM 6mg subcutanious on day 1 of ANTITHYMOCYTE GLOBULIN administration Control Intervention1: STANDARD TREATMENT: THOSE WHO ARE

Sponsors

JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: BONE MARROW PROVEN DIAGNOSIS OF APLASTIC ANEMIA

Exclusion criteria

Exclusion criteria: 1.Patients who have received ATG elsewhere 2.Patients with inherited bone marrow syndromes . 3.Patients with Hepatitis B or Hepatitis C

Design outcomes

Primary

MeasureTime frame
incidence of febrile neutropenia (measured by ANC count) in peg filgastrim group v/s control group.Timepoint: ABSOLUTE NEUTROPHIL COUNT WILL BE MEASURED AT BASELINE (0)AT THE TIME OF ADMISSION, AT 1 WEEK, 4 WEEKS, 12 WEEKS—

Secondary

MeasureTime frame
TO ASSESS RESPONSETimepoint: 1,3, 6 MONTHS—

Countries

India

Contacts

Public ContactDRAPARNAS

JIPMER (AUTONOMOUS)

drdeepakmddm@yahoo.co.in9442533124

Outcome results

None listed

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