NCT01623167 - Eltrombopag With Standard Immunosuppression for Severe Aplastic Anemia | Biotech Hunter

Enrollment

207

Participants

Timeline

Start Date

July 2, 2012

Primary Completion Date

January 30, 2018

Study Completion Date

November 30, 2029

Conditions

Severe Aplastic Anemia

Interventions

DRUG

Cohort 1: hATG, CsA, EPAG Day 14 to Month 6

hATG (standard of care) administered for 4 days, CsA (standard of care) administered starting day 1 for 6 months, eltrombopag (experimental) administered Day 14 to month 6

DRUG

Cohort 2: hATG, CsA, EPAG Day 14 to Month 3

hATG (standard of care) administered for 4 days, CsA (standard of care) administered starting day 1 for 6 months, eltrombopag (experimental) administered Day 14 to month 3

DRUG

Cohort 3: hATG, CsA (dose reduced), EPAG day 1 to month 6

hATG (standard of care) administered for 4 days, CsA (standard of care) administered starting day 1 for 6 months at higher dose, then reduced dose for 18 months, eltrombopag (experimental) administered Day 1 to month 6

DRUG

Extension Cohort

Receive horse ATG days 1- 4, receive CsA day 1 to month 6 at higher dose, then reduced dose for 18 months, and receive eltrombopag day 1 to month 6

Trial Locations (1)

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda