Low-Dose Danazol for the Treatment of Telomere Related Diseases
-
- STATUS
- Recruiting
Summary
DNA is a structure in the body. It contains data about how the body develops and works. Telomeres are found on the end of chromosomes in DNA. Some people with short telomeres or other gene changes can develop diseases of the bone marrow, lung, and liver. Researchers want to see if low doses of the hormone drug danazol can help.
Description
Researchers at the National Institutes of Health (NIH) are studying if the medication danazol can be used to treat people with short telomere disease who also have bone marrow failure, liver, or lung disease.
In recent studies, danazol, at high doses, showed a positive influence on telomore length. Additional research is needed to learn more about the role of danazol on telomere disease as well as its effects on secondary diseases. Eligible participants:
- Are 3 and older (minors must have parent/guardian consent to participate);
- Are diagnosed with a short telomere disease;
- Also have abnormalities affecting the bone marrow such as aplastic anemia or low blood counts OR lung disease OR liver disease
Study procedures:
- Before starting danazol, you will have tests and evaluations including measurements of your telomere length.
- Depending on your secondary disease you may also have a bone marrow biopsy, lung function tests, or evaluation of your liver.
- You will then begin taking danazol either 100 mg twice a day, or 200 mg twice a day for up to a year.
- While taking danazol you will have outpatient visits to the NIH Clinical Center after 6 months, a year, and 6 months after stopping danazol.
- Your participation in this study will last about 2 years.
Study-related tests, procedures, and medications are provided at no cost. Travel to and from the NIH, within the United States may be reimbursed.
Location: The NIH Clinical Center, America’s Research Hospital is located on the Metro red line (Medical Center stop) in Bethesda, Maryland.
Details
| Condition | Aplastic Anemia, Aplastic Anemia, Anemia; Non-Small-Cell Lung Cancer, Pulmonary Fibrosis, Pulmonary Fibrosis, Telomeres Hepatic Fibrosis Liver Disease Lung Disease |
|---|---|
| Clinical Study Identifier | TX217972 |
| Last Modified on | 22 December 2020 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer