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Comparison of Two Different Doses of Rabbit ATG-Fresenius With Cyclosporin in the Treatment of Acquired Aplastic Anaemia

NCT02028416 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-04-05

No results posted yet for this study

Summary

Acquired Aplastic anemia is one of the most frequent reason of bone marrow failure in East (Pakistan).

* The first treatment option is Allogenic Bone Marrow transplantation which is an expansive treatment option and also require a full matched HLA identical donor, hence hardly 25% of our affected patients get opportunity for BMT.
* The second line treatment option caters a large chunk of patients (severe and non-severe AA) along with those who lack HLA identical donor.

Previously many protocols had been used in past for ATG+CsA Treatment, this treatment protocol especially addresses the two different regimens of ATG to study its efficacy, durability and long-term effects. Following doses would be used:

* CsA+ATG @ 10mg/kg for 3 days
* CsA+ATG @ 10mg/kg for 5 days

Conditions

  • Aplastic Anemia

Interventions

DRUG

ATG-fresenius

we will create 2 arms as per randomization table. Both arms will receive ATG-Fresenius but with 2 different regimens. the first arm will receive ATG-F @10mg/kg for 3 days and second arm will receive ATG-F same dose but for 5 days

Sponsors & Collaborators

  • National Institute of Blood Disease Center, Pakistan

    lead OTHER

Principal Investigators

  • TAHIR S SHAMSI, MBBS,FRCPath · NATIONAL INSTITUTE OF BLOOD DISEASES AND BONE MARROW TRANSPLANTATION

  • MEHWESH TAJ, MBBS, FCPS · NATIONAL INSTITUTE OF BLOOD DISEASES AND BONE MARROW TRANSPLANTATION

  • UZMA RIZVI, MBBS · NATIONAL INSTITUTE OF BLOOD DISEASES AND BONE MARROW TRANSPLANTATION

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Pakistan

Study Locations

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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 NCT02028416 on ClinicalTrials.gov