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

Acquired Aplastic Anemia. Clinical Trial

Official title:

A Prospective Randomized Multicenter Study Comparing Different Dosages of Rabbit Antithymocyte Globulin (Thymoglobuline) in Patients With Severe Aplastic Anemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01844635
• Other study ID #: APBMT AAWG-01
• Status: Recruiting
• Phase: Phase 3
• First received: April 29, 2013
• Last updated: March 31, 2016
• Start date: May 2012

Study information

• Verified date: March 2016
• Source: Nagoya University
• Contact: Seiji Kojima, MD., PhD.
• Phone: +81-52-744-2294
• Email: kojimas[@]med.nagoya-u.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 69 Years

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Aplastic Anemia.
• Anemia, Aplastic

Intervention

Drug:
• Thymoglobulin

Locations

Country	Name	City	State
Japan	Department of Pediatrics, Nagoya University Graduate School of Medicine	Nagoya	Aichi

Sponsors (1)

Lead Sponsor	Collaborator
Nagoya University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematologic response (complete response (CR) or partial response (PR)) in patients with immunosuppressive therapy (IST) on day 180 after the start of IST.		day 180 after the start of IST	No