Actively Recruiting
Danazol for Treatment of Cytopenias in Patients With Cirrhosis
Led by University of Southern California · Updated on 2025-07-11
10
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Danazol for Treatment of Cytopenias in Patients With Cirrhosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and able to provide informed consent
- ECOG performance status 0 to 2
- Compensated Child-Pugh class A cirrhosis of any cause except chronic hepatitis B with defined leukopenia and thrombocytopenia measured twice at least 3 months apart within 6 months before enrollment
- Compensated Child-Pugh class B cirrhosis of any cause except chronic hepatitis B with defined leukopenia and thrombocytopenia measured twice at least 3 months apart within 6 months before enrollment
- Presence of a genetic variant in specified telomere-related genes or shortened telomere length at or below the 5th percentile in blood cells
- Women of childbearing potential must agree to use highly effective contraception or abstain from heterosexual intercourse during treatment
- Women of childbearing potential must have a negative serum pregnancy test within 72 hours before treatment start
You will not qualify if you...
- Cirrhosis caused by chronic hepatitis B or any history of hepatitis B
- Telomere mutations known to cause gain of function
- Known HIV infection
- History of hormone-sensitive cancers or high risk for malignancy
- Currently receiving anti-cancer therapy
- Liver decompensation events within 6 months prior
- Active thrombosis or history of unprovoked thromboembolic disease unless adequately treated
- Pregnant or planning pregnancy
- Breastfeeding females
- Contraindications to danazol use
- Uncontrolled serious health conditions including severe heart failure, unstable angina, uncontrolled arrhythmia, decompensated liver failure, or severe kidney impairment
- Elevated liver enzymes or bilirubin above specified limits
- Recent alcohol or drug abuse within the last year
- Use of hormone stimulants or blockers
- Use of other bone marrow stimulating agents except short-term standard care use
- Use of systemic immunosuppressive medications
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Keck Hosital of USC
Los Angeles, California, United States, 90033
Actively Recruiting
Research Team
I
Ibrahim Syed, MBBS
CONTACT
C
Caitlin O'Neill, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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