PRETELL: PREvention of TELomere-related Complications After Lung Transplant
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Placebo comparison |
Drug: Placebo
Placebo twice a day
|
| Active Comparator: Danazol Pill Danazol 200mg orally twice a day |
Drug: Danazol Pill
Danazol 200 mg orally twice a day
|
Outcome Measures
Primary Outcome Measures
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [48 weeks]
The incidence, severity, outcome, and relationship to study treatment of adverse events and serious adverse events. Change from baseline in clinical laboratory test results.
Secondary Outcome Measures
- Occurrence of WBC <2000/µl [48 weeks]
-Occurrence of WBC <2000/µl at any time during study period.
- Cumulative number of events where WBC < 2000/µl [48 weeks]
- Evaluating cumulative number of events where WBC < 2000/µl
Other Outcome Measures
- Telomere length [48 weeks]
-Measure change in lymphocyte telomere length at end of study drug administration compared to screening
Eligibility Criteria
Criteria
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
-
Patients with abnormal liver function AST, ALT >3 times normal
-
Subjects with a history of benign intracranial hypertension
-
Subjects with a history of liver disease not limited to alcoholic hepatitis/cirrhosis, non-alcoholic steatohepatitis (NASH), autoimmune hepatitis (AIH), primary biliary cirrhosis (PBC), and/or history of hepatic adenoma.
-
Subjects with poorly controlled or uncontrolled Type I or II diabetes mellitus
-
Significant renal abnormalities GFR< 40 ml/min/m2
-
Significant cardiac dysfunction with ejection fraction less than 50%
-
Moribund status such as death is expected in the coming year
-
Currently taking carbamazepine, pimozide or lomitapide
-
Inability to understand the investigational nature of the study or to give informed consent
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Brigham and Women's Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021P000271