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hATG+CsA vs hATG+CsA+Eltrombopag for SAA

NCT02099747 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2026-04-24

No results posted yet for this study

Summary

The null hypothesis of no difference in CR% at 3 months between the arms will be tested against the alternative of a difference in CR% at an alpha level of .05 by assessing the odds ratio for arm yielded by this model.

Conditions

  • Severe Aplastic Anemia

Interventions

DRUG

hATG

DRUG

CsA

DRUG

Eltrombopag

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • European Society for Blood and Marrow Transplantation

    lead NETWORK

Principal Investigators

  • Antonio Risitano, MD, PhD · Federico II Medical School, Haematology Division, Napels

  • Regis Peffault de Latour, MD, PhD · St. Louis Hospital, Haematology Division, Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • France
  • Italy
  • Netherlands
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02099747 on ClinicalTrials.gov