ClinicalTrials.Veeva

Menu

Randomised Study Comparing Different Dosages of Rabbit ATG in Patients With SAA

T

Tokai National Higher Education and Research System

Status and phase

Unknown
Phase 3

Conditions

Acquired Aplastic Anemia.

Treatments

Drug: Thymoglobulin

Study type

Interventional

Funder types

Other

Identifiers

NCT01844635
APBMT AAWG-01

Details and patient eligibility

About

The objective of this study is to evaluate the feasibility and effectiveness of immunosuppressive therapy (IST) using rabbit anti-thymocyte globulin (ATG) (Thymoglobuline, Genzyme) for patients with very severe aplastic anemia (VSAA) and severe aplastic anemia (SAA) as a primary therapy. The primary endpoint is the response rate (complete response (CR) + partial response (PR)) at day 180 after the start of IST. Secondary endpoints include evaluation of the presence and frequency of Epstein-Barr virus (EBV)-reactivation and EBV-associated lymphoproliferative disorder (EBV-LPD), Cytomegalovirus(CMV)-reactivation and CMV associated diseases, the response rate (CR+PR) on Day 360 after the start of IST, relapse rate and overall survival.

Enrollment

320 estimated patients

Sex

All

Ages

Under 69 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Acquired aplastic anemia
  • Age: younger than 70 years old
  • Severity: SAA, VSAA.
  • Interval between diagnosis and registration <6 months.
  • Written informed consent from the caretakers and/or whenever possible consent from the patient.

Exclusion criteria

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

320 participants in 2 patient groups

2.5 mg/kg/day of Thymoglobulin for 5 days
Experimental group
Description:
2.5 mg/kg/day of Thymoglobulin for 5 days
Treatment:
Drug: Thymoglobulin
3.5 mg/kg/day of Thymoglobulin for 5 days
Active Comparator group
Description:
3.5 mg/kg/day of Thymoglobulin for 5 days
Treatment:
Drug: Thymoglobulin

Trial contacts and locations

1

Loading...

Central trial contact

Hideki Muramatsu, MD., PhD.; Seiji Kojima, MD., PhD.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems