PRETELL: PREvention of TELomere-related Complications After Lung Transplant

NCT ID: NCT04807309

Last Updated: 2023-02-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-01-01

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.

Conditions

Short Telomere Length; Lung Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo comparison

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo twice a day

Danazol Pill

Danazol 200mg orally twice a day

Group Type: ACTIVE_COMPARATOR

Danazol Pill

Intervention Type: DRUG

Danazol 200 mg orally twice a day

Interventions

Danazol Pill

Danazol 200 mg orally twice a day

Intervention Type: DRUG

Placebo

Placebo twice a day

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Souheil El-Chemaly, MD, MPH

Associate Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2021P000271

Identifier Type: -

Identifier Source: org_study_id