Danazol for Treatment of Cytopenias in Patients With Cirrhosis

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT04873102
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cirrhosis, Liver
  • Cytopenia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Danazol Pill — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 1, 2024
Status verified
Jul 2025
Primary completion
Aug 1, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Danazol in Treatment of Cytopenias
    AGENT: Danazol 600mg, Oral, Daily for 24 months

Primary Outcome Measure

Hematologic Response [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Keck Hosital of USCLos AngelesCalifornia90033
Casey O'Connell, MD
[email protected]
323-865-3000
Caitlin O'Neill, MD
[email protected]
323-865-3000

Find similar trials in Los Angeles, CA

By research site
Keck Hosital of USC· Los Angeles, CA

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