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Danazol for Low Blood Counts in Liver Cirrhosis
Study Summary
This trial will test if a drug called danazol is safe and effective for treating low blood counts in patients with a certain type of liver disease.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have cirrhosis due to chronic hepatitis B or have had hepatitis B.I am 18 or older and can give my consent.I do not have telomere mutations that increase their function.I don't have active blood clots or a history of unexplained clotting, or I've completed treatment for a clot caused by a known reason.My liver functions well despite my condition, except I don't have chronic hepatitis B but do have low blood cell counts.I can take care of myself and am up and about more than half of the day.I have not had a serious liver event in the last 6 months.I am not taking any medications that weaken my immune system.I am currently using hormone stimulants or blockers.I am not using medications that affect blood cell counts, except for short-term or low-dose steroids.I have a moderate liver condition but not due to chronic hepatitis B, and I have low blood cell counts.My blood test shows I have very short telomeres for my age.I have a genetic mutation in one of the specified genes linked to my condition.I am using a highly effective birth control method.I am a woman who can still have children.I understand that periodic abstinence and withdrawal are not accepted as contraception methods for this trial.I have or am at high risk for hormone-sensitive cancer due to family history.I do not have severe heart, liver, kidney problems, or mental health issues that would make taking danazol unsafe.You have had problems with alcohol or drugs within the past year.I am currently breastfeeding.I cannot take danazol due to health reasons.I am currently undergoing treatment for cancer.I do not have mutations in my genes that cause them to act abnormally.
- Group 1: Danazol in Treatment of Cytopenias
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many participants is the research project recruiting?
"This research trial has reached its capacity and is no longer enrolling patients. Initially posted on May 1st 2021, the study was last updated April 29th of the same year. For those looking to join a similar clinical trial, there are 796 leukopenia-specific studies taking participants as well as 8 trials related to Danazol Pill in progress."
Does this research endeavor still need volunteers?
"Unfortunatley, no new participants are currently being accepted for this clinical trial. Its opening date was May 1st 2021 and its last update was on April 29th 2021. If you seek other studies, there are 796 trials recruiting patients suffering with leukopenia and 8 that involve Danazol Pill as a treatment option."
Have there been any other clinical research studies that have focused on Danazol Pill?
"Presently, 8 clinical trials are taking place to test the efficacy of Danazol Pill. Of these studies, 2 have reached phase 3. Though most of them occur in Los Angeles, 346 different sites across the country offer this research-based treatment option."
What aims does this experiment have?
"This two year long study is primarily focused on the emergence of grade 3+ adverse events, although other outcomes such as incidence of clinical decompensation (variceal hemorrhage, ascites requiring intervention, and hepatic encephalopathy), transplant-free survival (time from study entry until liver transplant) and overall survival (time from study entry until death) will also be monitored."
What medical ailment is Danazol Pill typically prescribed to treat?
"Danazol Pill is a viable solution for inherited breast cancer, angioedemas, thrombocytopenia and similar conditions."
What potential risks may be associated with Danazol Pill ingestion?
"Danazol Pill has been evaluated to a score of 2, as this is only the second phase in its clinical trials. While there exists some data demonstrating safety, no efficacy evidence has thus far emerged."
Is this trial pioneering in its approach?
"Since 2017, PSI CRO has been researching Danazol Pill. The initial trial in that year involved 399 patients and culminated with the Phase 3 drug approval for this medication. As of today, there are 8 active trials spanning 28 countries and 133 cities worldwide."
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