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RECRUITING
NCT04873102
PHASE2

Danazol for Treatment of Cytopenias in Patients With Cirrhosis

Sponsor: University of Southern California

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase II Single Center Single Arm Pilot Study Administering Danazol for Treatment of Cytopenias in Patients With Cirrhosis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2024-08-01

Completion Date

2027-08-01

Last Updated

2025-07-11

Healthy Volunteers

No

Interventions

DRUG

Danazol Pill

Danazol is a synthetic steroid derived from ethisterone, It suppresses the pituitary-ovarian axis by inhibiting the pituitary output of gonadotropins. The pituitary-suppressive action of danazol is reversible. Danazol has been approved in treating endometriosis, fibrocystic breast disease, hereditary angioedema, thrombocytopenic purpura, and other conditions. It is metabolized and eliminated by renal and fecal pathways. The mean half-life of danazol in healthy males is 9.7 hours. After 6 months of 200 mg three times a day dosing in endometriosis patients, the half-life of danazol was reported as 23.7 hours. Adverse reactions from danazol include androgen like effects (i.e. weight gain, acne, mild hirsutism, edema, hair loss, voice change) and menstrual disturbances. The use of danazol in pregnancy is contraindicated. Other side effects include elevations in liver-enzyme levels and lipid abnormalities.

Locations (1)

Keck Hosital of USC

Los Angeles, California, United States