Short Telomere LengthPhase 1/2PRETELLNCT04807309
PRETELL: PREvention of TELomere-related Complications After Lung Transplant
A Phase 1/2 study testing Danazol Pill in people with Short Telomere Length and Lung Transplant, run by Brigham and Women's Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Short Telomere Length, Lung Transplant
- What is being tested?
- Danazol Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 1 Jan 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
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
- Being tested
- Danazol Pill, Placebo
- Keywords
- Danazol, Short telomere, Lung transplant, Prevention, Leukopenia
- Medical subject headings
- Leukopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Danazol PillDrug
Danazol 200 mg orally twice a day
PlaceboDrug
Placebo twice a day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo comparison Receives: Drug: Placebo |
| Danazol Pill | Active comparator | Danazol 200mg orally twice a day Receives: Drug: Danazol Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 weeks
Secondary outcomes (2)
Occurrence of WBC <2000/µl
-Occurrence of WBC <2000/µl at any time during study period.
Measured: 48 weeks
Cumulative number of events where WBC < 2000/µl
- Evaluating cumulative number of events where WBC < 2000/µl
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start1 Jan 2021
- Primary completion20 Nov 2021
- Study completion1 Jan 2022
Why it stopped: Lack of financial support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Telomere LengthStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double blind 2:1 ratio
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Souheil El-Chemaly, MD, MPH, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807309
- Sponsor's protocol ID
- 2021P000271
- Acronym
- PRETELL
- Status last verified
- Feb 2023
- First submitted
- 15 Mar 2021
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRETELL: PREvention of TELomere-related Complications After Lung Transplant
- ClinicalTrials.gov ID
- NCT04807309
- Acronym / sponsor ID
- PRETELL / 2021P000271
- Conditions
- Short Telomere Length, Lung Transplant
- Keywords
- Danazol, Short telomere, Lung transplant, Prevention, Leukopenia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of financial support
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 20 Nov 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double blind 2:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo comparison |
| Danazol Pill | Active comparator | Drug: Danazol PillDanazol 200mg orally twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Danazol PillDanazol 200 mg orally twice a day | Drug | Danazol Pill |
| PlaceboPlacebo twice a day | Drug | Placebo |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 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.
2 secondary outcomes
Occurrence of WBC <2000/µl
Time frame: 48 weeks
Cumulative number of events where WBC < 2000/µl
Time frame: 48 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Danazol Pill in people with Short Telomere Length and Lung Transplant, run by Brigham and Women's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.