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

Information source: Nagoya University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acquired Aplastic Anemia.

Intervention: Thymoglobulin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Nagoya University

Official(s) and/or principal investigator(s):
Seiji Kojima, MD., PhD., Principal Investigator, Affiliation: Department of Pediatrics, Nagoya University Graduate School of Medicine

Overall contact:
Seiji Kojima, MD., PhD., Phone: +81-52-744-2294, Email: kojimas@med.nagoya-u.ac.jp

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.

Clinical Details

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

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

Primary outcome: Hematologic response (complete response (CR) or partial response (PR)) in patients with immunosuppressive therapy (IST) on day 180 after the start of IST.

Eligibility

Minimum age: N/A. Maximum age: 69 Years. Gender(s): Both.

Criteria:

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:

-

Locations and Contacts

Seiji Kojima, MD., PhD., Phone: +81-52-744-2294, Email: kojimas@med.nagoya-u.ac.jp

Department of Pediatrics, Nagoya University Graduate School of Medicine, Nagoya, Aichi 466-8550, Japan; Recruiting
Seiji Kojima, MD., PhD., Phone: +81-52-744-2294, Email: kojimas@med.nagoya-u.ac.jp
Hideki Muramatsu, MD., PhD., Phone: +81-52-744-2294, Email: hideki-muramatsu@med.nagoya-u.ac.jp
Seiji Kojima, MD., PhD., Principal Investigator
Additional Information

Starting date: May 2012
Last updated: April 14, 2015

Page last updated: August 23, 2015

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