Danazol for Treatment of Cytopenias in Patients With Cirrhosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Southern California
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.
Eligibility criteria
Qualifiers
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
Leukopenia defined as white blood cell count <2000/mm3 or absolute neutrophil count <1000/mm3 along with thrombocytopenia <150,000/mm3 measured on two separate occasions at least 3 months apart within 6 months of enrollment
Disqualifiers
Cirrhosis secondary to chronic hepatitis B or any history of hepatitis B
Patients with telomere related mutations know to confer gain of function will be excluded
Patients known to be infected with HIV
History of any hormone sensitive malignancy, including breast cancer, prostate cancer, hepatocellular carcinoma or liver adenoma as well as any patient considered high risk for developing malignancy (i.e. history of familial cancers including a first degree relative)
Trial design
Treatments tested in this trial
- Danazol Pill
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov