Danazol for Treatment of Cytopenias in Patients With Cirrhosis

Recruiting Phase 2 Interventional Study
Cirrhosis, Liver Cytopenia
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
10 (estimated)
Sponsor
University of Southern California · Other
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About This Trial

This is a phase II pilot study designed to assess the safety and efficacy of danazol for treatment of cytopenias in patients with CPC A/B cirrhosis. Subjects with or without telomere mutations and/or shortened telomeres will be treated with danazol 600 mg per day by mouth for a duration of 24 months. The goal will be to treat a total of 10 patients.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age 18 years or older and able to provide informed consent * ECOG 0-2 * Compensated Child-Pugh class A of any etiology with the exception of chronic hepatitis B with one or more of the following cytopenias 1. Leukopenia defined as white blood cell count \<2000/mm3 or absolu…
Contacts

Ibrahim Syed, MBBS

323-865-3000

isyed@med.usc.edu

CONTACT

Caitlin O'Neill, MD

323-865-3000

caitlin.oneill@med.uc.edu

CONTACT