WithdrawnPhase 1/2

PRETELL: PREvention of TELomere-related Complications After Lung Transplant

Stopped: Lack of financial support

0Started 2021-01-01

Plain-language summary

To evaluate the safety and efficacy of Danzol in lung transplant recipients with short telomeres. Subjects with short telomeres recipient of lung transplant, will be randomized in the first month post-transplant to either placebo or Danazol (200mg bid) in a 2:1 ratio.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age greater than 18
✓. Ability to give informed consent
✓. Recipient of lung transplantation
✓. Short telomeres assessed either pre-transplant or post-transplant with FLOW-FISH as lymphocyte telomere length \<10th percentile predicted for age
✓. Clinically stable one month after lung transplant

Exclusion criteria

✕. Patients on androgen hormones to include testosterone or high dose estrogen (estradiol 0.5 mg/day or greater) during 12 months prior to enrollment
✕. Patients with active thrombosis or thromboembolic disease and history of such events unless thrombosis is line related.
✕. Undiagnosed abnormal genital bleeding, porphyria, androgen-dependent tumor, or prostatic hypertrophy
✕. Patients with active hepatitis B or C
✕. Patients who have received a bone marrow transplant
✕. Clinically unstable after lung transplantation
✕. Current pregnancy, or unwillingness to take be on two forms of contraceptives including a barrier method of birth control or practice abstinence to refrain from pregnancy if of childbearing potential during the course of the study
✕. Lactating women, due to the potentially harmful effects on the nursing child

What they're measuring

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Timeframe: 48 weeks

Trial details

NCT IDNCT04807309

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-20

View on ClinicalTrials.gov More Short Telomere Length trials