Is NCT04873102 recruiting in Los Angeles, CA?

Yes, NCT04873102 is currently recruiting participants at its Los Angeles, CA location. This cirrhosis, liver clinical trial is actively enrolling qualified participants.

How do I join the cirrhosis, liver clinical trial in Los Angeles?

To join this clinical trial in Los Angeles, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Los Angeles clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Cirrhosis, Liver Clinical Trial in Los Angeles, CA

About This Cirrhosis, Liver Study in Los Angeles

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.

Sponsor: University of Southern California

Who Can Participate

Inclusion Criteria

Age 18 years or older and able to provide informed consent

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

Thrombocytopenia defined as platelet count \<50,000/mm3 along with white blood cell count \<4000/mm3 measured on two separate occasions at least 3 months apart within 6 months of enrollment

Compensated Child-Pugh class B cirrhosis 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 ≤ 3500/mm3 measured on two separate occasions at least 3 months apart within 6 months of enrollment 3. Thrombocytopenia defined as platelet count ≤ 100,000/mm3 measured on two separate occasions at least 3 months apart within 6 months of enrollment

Enrolled patients must have one or more of the following:

Presence of a genetic variant (defined as a known mutation, variant likely to be pathogenic or variant of undetermined significance with likely deleterious effect on transcription or translation) in at least one of the following genes: TERT, TERC, RTEL1, DKC, NOP10, NHP2, TINF2, WRAP53

Shortened telomere length in peripheral blood mononuclear cells (defined as age-adjusted telomere length at or below the 5th percentile)

Of note, patient's found to have telomere mutations know to confer a gain of function will be excluded

For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \< 1% per year during the treatment period

A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\>= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus)

Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices

The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception

Women of childbearing potential (WOCBP) must have a negative serum test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 72 hours prior to the start of treatment

Exclusion Criteria

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)

Patients who are actively receiving anti-cancer therapy

Liver decompensation event within the last 6 months (i.e. variceal bleed, ascites requiring paracentesis, hepatic encephalopathy)

Active thrombosis or history of unprovoked thromboembolic disease, including cardiovascular events. If a patient has received and completed adequate anticoagulation for a provoked thrombosis, they can be included in the study.

Pregnant or planning to become pregnant

Females patients who are breast feeding

Any contraindication to danazol use

Uncontrolled co-morbid condition which would make the administration of danazol unsafe, including decompensated heart failure or known EF less than 40%, unstable angina pectoris, uncontrolled cardiac arrhythmia, decompensated liver failure, renal failure defined as creatinine greater than \>1.6 or psychiatric illness that would limit compliance with study requirements

Alanine aminotransferase and/or aspartate aminotransferase \>3x upper limit of normal

Alkaline phosphatase \>2.5 x upper limit of normal

Total bilirubin or direct bilirubin \>2.5 x upper limit of normal

Patients with known alcohol or drug abuse within the last year

Concomitant use of hormone stimulants or hormone blocking agents.

Concomitant use of other bone marrow stimulating agents that may affect white blood cell and platelet counts (i.e. G-CSF, romiplostim, eltrombopag, corticosteroids). Short term use of growth factors per standard of care in preparation for procedure or for other medical indications is acceptable. Patients taking corticosteroids above 5 mg of prednisone or the equivalent who are on a stable dose for at least 8 weeks prior to enrollment can be included.

Concomitant treatment with systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Los Angeles?

Yes, this clinical trial (NCT04873102) has an active research site in Los Angeles, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Cirrhosis, Liver Treatment Options in Los Angeles, CA

If you're searching for cirrhosis, liver treatment options in Los Angeles, CA, this clinical trial (NCT04873102) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Los Angeles research site is actively enrolling participants for this clinical trial. You'll receive care from experienced cirrhosis, liver specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all cirrhosis, liver clinical trials near you to find additional studies recruiting in your area.

Cirrhosis, Liver Clinical Trial in Los Angeles, CA

Expert Care in Los Angeles

IRB Approved

No-Cost Care

Apply for This Los Angeles Location

Why Participate?

Simple Process