PRETELL: PREvention of TELomere-related Complications After Lung Transplant

Lung Transplant Clinical Trial

— PRETELL  

Official title:

PRETELL: PREvention of TELomere-related Complications After Lung Transplant

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04807309
• Other study ID #: 2021P000271
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: January 1, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: February 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2022
• Est. primary completion date: November 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age greater than 18

2. Ability to give informed consent

3. Recipient of lung transplantation

4. Short telomeres assessed either pre-transplant or post-transplant with FLOW-FISH as lymphocyte telomere length <10th percentile predicted for age

5. Clinically stable one month after lung transplant

Exclusion Criteria:

1. Patients on androgen hormones to include testosterone or high dose estrogen (estradiol 0.5 mg/day or greater) during 12 months prior to enrollment

2. Patients with active thrombosis or thromboembolic disease and history of such events unless thrombosis is line related.

3. Undiagnosed abnormal genital bleeding, porphyria, androgen-dependent tumor, or prostatic hypertrophy

4. Patients with active hepatitis B or C

5. Patients who have received a bone marrow transplant

6. Clinically unstable after lung transplantation

7. 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

8. Lactating women, due to the potentially harmful effects on the nursing child

9. Patients with abnormal liver function AST, ALT >3 times normal

10. Subjects with a history of benign intracranial hypertension

11. 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.

12. Subjects with poorly controlled or uncontrolled Type I or II diabetes mellitus

13. Significant renal abnormalities GFR< 40 ml/min/m2

14. Significant cardiac dysfunction with ejection fraction less than 50%

15. Moribund status such as death is expected in the coming year

16. Currently taking carbamazepine, pimozide or lomitapide

17. Inability to understand the investigational nature of the study or to give informed consent

Related Conditions & MeSH terms

• Lung Transplant
• Short Telomere Length

Intervention

Drug:
• Danazol Pill
Danazol 200 mg orally twice a day
• Placebo
Placebo twice a day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Telomere length	-Measure change in lymphocyte telomere length at end of study drug administration compared to screening	48 weeks
Primary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	The incidence, severity, outcome, and relationship to study treatment of adverse events and serious adverse events.; Change from baseline in clinical laboratory test results.	48 weeks
Secondary	Occurrence of WBC <2000/µl	-Occurrence of WBC <2000/µl at any time during study period.	48 weeks
Secondary	Cumulative number of events where WBC < 2000/µl	- Evaluating cumulative number of events where WBC < 2000/µl	48 weeks