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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04638517




Registration number
NCT04638517
Ethics application status
Date submitted
4/11/2020
Date registered
20/11/2020

Titles & IDs
Public title
The TELO-SCOPE Study: Attenuating Telomere Attrition With Danazol. Is There Scope to Dramatically Improve Health Outcomes for Adults and Children With Pulmonary Fibrosis
Scientific title
The TELO-SCOPE Study: Attenuating Telomere Attrition With Danazol. Is There Scope to Dramatically Improve Health Outcomes for Adults and Children With Pulmonary Fibrosis
Secondary ID [1] 0 0
TELO-SCOPE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Fibrosis 0 0
Telomere Shortening 0 0
Telomere Disease 0 0
Dyskeratosis Congenita 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Danazol
Treatment: Drugs - Placebo

Active comparator: Danazol - 800mg daily in two divided doses orally for 12 months. In subjects who have difficulty tolerating danazol / placebo, the dose will be reduced by 200mg/day and side effects will be reassessed. If symptoms related to the study drug persist, subsequent 200mg/day dose reductions will be allowed until a tolerated dose is achieved. Background antifibrotic therapy is allowed.

Placebo comparator: Placebo - Matching placebo capsules.


Treatment: Drugs: Danazol
Danazol up to 800mg daily in two-divided doses.

Treatment: Drugs: Placebo
Matching placebo.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in absolute telomere length from baseline (base pairs)
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Number of participants with treatment-emergent adverse events
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Number of Participants With Death or Non-Elective Hospitalisation
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Change in telomere length from baseline to 3, 6 and 9 months (base pairs)
Timepoint [3] 0 0
3, 6 and 9 months
Secondary outcome [4] 0 0
Change in forced vital capacity (FVC) at 6 and 12 months
Timepoint [4] 0 0
6 and 12 months
Secondary outcome [5] 0 0
Change in diffusing capacity for carbon monoxide at 6 and 12 months
Timepoint [5] 0 0
6 and 12 months
Secondary outcome [6] 0 0
Change in 6-minute walk distance from baseline
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
Change in Leicester cough questionnaire (LCQ) from baseline
Timepoint [7] 0 0
12 months
Secondary outcome [8] 0 0
Change in King's Brief Interstitial Lung Disease Questionnaire (K-BILD) from baseline
Timepoint [8] 0 0
12 months
Secondary outcome [9] 0 0
Change in Parent cough-specific quality of life (PCSQoL) from baseline
Timepoint [9] 0 0
12 months

Eligibility
Key inclusion criteria
1. Males and females aged >5 years, able to take capsules orally.
2. Fibrosing interstitial pneumonia (Idiopathic PF, idiopathic non-specific interstitial pneumonia, chronic hypersensitivity pneumonitis, pleuroparenchymal fibroelastosis, unclassifiable interstitial lung disease (ILD)) diagnosed according to the current international guidelines.
3. Age-adjusted peripheral blood leukocyte telomere length < 10th centile on Flow-FISH.
4. FVC > 40% predicted.
5. DLCO > 25% predicted.
6. If receiving background pirfenidone / nintedanib, stable dose for 28 days prior to screening.
7. Able to understand and sign a written informed consent form (or legally authorised representative).
8. Agreement to use a medically approved form of non-hormonal contraception (if of child-bearing potential) (noting that oral contraceptives are advised not to be used concurrently with danazol).
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Actively or imminently listed for lung transplantation.
2. Undergone, awaiting, or likely to require bone marrow transplantation within 12 months.
3. Concurrent enrolment in another study.
4. Females with a positive pregnancy test at screening or currently breastfeeding.
5. Pelvic infection.
6. Past jaundice with oral contraceptives.
7. Undiagnosed abnormal genital bleeding.
8. Undiagnosed ovarian/uterine masses
9. Any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 12 months.
10. History of androgen-dependent tumour.
11. Any condition other than PF that, in the opinion of the investigator, is likely to result in the death of the participant within the next 12 months.
12. History of end-stage liver disease or ALT or AST > 3 times the upper limit of normal.
13. History of end-stage kidney disease requiring dialysis.
14. Markedly impaired cardiac function.
15. Known increased risk of or history of thromboembolism (e.g. Factor V Leiden, Protein C or S deficiency).
16. Uncontrolled hypertension.
17. Uncontrolled lipoprotein disorder.
18. Poorly-controlled diabetes mellitus.
19. History of marked or persistent androgenic reaction to previous gonadal steroid therapy.
20. History of epilepsy induced or worsened by previous gonadal steroid therapy.
21. History of raised intracranial pressure.
22. Known intolerance to danazol.
23. Porphyria.
24. Use of any of the following agents within 28 days before screening: danazol or other androgen therapy, warfarin or other anticoagulant, carbamazepine, phenytoin, investigational therapy, cytotoxic therapy, tacrolimus, cyclosporine.
25. Professional singer due to potential for voice change.
26. Competitive athletes.
27. Prostate specific antigen (PSA) above the upper limit of normal (adult males only).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [2] 0 0
Sydney Children's Hospital - Sydney
Recruitment hospital [3] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [4] 0 0
The Children's Hospital Westmead - Sydney
Recruitment hospital [5] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 0 0
The Alfred - Melbourne
Recruitment hospital [8] 0 0
The Austin - Melbourne
Recruitment hospital [9] 0 0
Fiona Stanley Hospital - Perth
Recruitment postcode(s) [1] 0 0
2305 - Newcastle
Recruitment postcode(s) [2] 0 0
2031 - Sydney
Recruitment postcode(s) [3] 0 0
2050 - Sydney
Recruitment postcode(s) [4] 0 0
2145 - Sydney
Recruitment postcode(s) [5] 0 0
4032 - Brisbane
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
3084 - Melbourne
Recruitment postcode(s) [9] 0 0
6150 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Daniel Chambers
Address 0 0
Country 0 0
Phone 0 0
07 3139 4000
Fax 0 0
Email 0 0
daniel.chambers@health.qld.gov.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data will be analysed and shared with collaborators with the plan to publish the results.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04638517