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Pulmonary FibrosisPhase 2NCT04638517

The TELO-SCOPE Study: Attenuating Telomere Attrition With Danazol. Is There Scope to Dramatically Improve Health Outcomes for Adults and Children With Pulmonary Fibrosis

A Phase 2 study testing Danazol in people with Pulmonary Fibrosis and Telomere Shortening, run by The University of Queensland at 9 sites in Australia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

TELO-SCOPE is a national, multi-centre, double-blind, placebo-controlled, randomised (2:1) trial which will test the hypothesis that, compared to placebo, the addition of danazol to standard of care in pulmonary fibrosis associated with short telomeres is safe and will result in reduced telomere attrition. Read more about this study

Who is it for?
Ages 5 years and older
What is being tested?
Danazol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
29 participants
Where
9 sitesAustralia
Study dates
7 Sep 2021to 16 Jan 2025
Phase
Phase 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 5 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Males and females aged >5 years, able to take capsules orally.
  • 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.
  • Age-adjusted peripheral blood leukocyte telomere length < 10th centile on Flow-FISH.
  • FVC > 40% predicted.
  • DLCO > 25% predicted.
  • If receiving background pirfenidone / nintedanib, stable dose for 28 days prior to screening.
  • Able to understand and sign a written informed consent form (or legally authorised representative).
  • 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).

Who cannot join

  • Actively or imminently listed for lung transplantation.
  • Undergone, awaiting, or likely to require bone marrow transplantation within 12 months.
  • Concurrent enrolment in another study.
  • Females with a positive pregnancy test at screening or currently breastfeeding.
  • Pelvic infection.
  • Past jaundice with oral contraceptives.
Show all 27Show fewer
  • Undiagnosed abnormal genital bleeding.
  • Undiagnosed ovarian/uterine masses
  • Any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 12 months.
  • History of androgen-dependent tumour.
  • 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.
  • History of end-stage liver disease or ALT or AST > 3 times the upper limit of normal.
  • History of end-stage kidney disease requiring dialysis.
  • Markedly impaired cardiac function.
  • Known increased risk of or history of thromboembolism (e.g. Factor V Leiden, Protein C or S deficiency).
  • Uncontrolled hypertension.
  • Uncontrolled lipoprotein disorder.
  • Poorly-controlled diabetes mellitus.
  • History of marked or persistent androgenic reaction to previous gonadal steroid therapy.
  • History of epilepsy induced or worsened by previous gonadal steroid therapy.
  • History of raised intracranial pressure.
  • Known intolerance to danazol.
  • Porphyria.
  • 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.
  • Professional singer due to potential for voice change.
  • Competitive athletes.
  • Prostate specific antigen (PSA) above the upper limit of normal (adult males only).

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Australia9 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • The Prince Charles Hospital

    Brisbane, Queensland, 4032

  • The Alfred

    Melbourne, Victoria, 3004

  • The Austin

    Melbourne, Victoria, 3084

  • John Hunter Hospital

    Newcastle, New South Wales, 2305

  • Fiona Stanley Hospital

    Perth, Western Australia, 6150

  • Sydney Children's Hospital

    Sydney, New South Wales, 2031

  • Royal Prince Alfred Hospital

    Sydney, New South Wales, 2050

  • The Children's Hospital Westmead

    Sydney, New South Wales, 2145

Other trials in Australia

About this study

TELO-SCOPE is a national, multi-centre, double-blind, placebo-controlled, randomised (2:1) trial which will test the hypothesis that, compared to placebo, the addition of danazol to standard of care in pulmonary fibrosis associated with short telomeres is safe and will result in reduced telomere attrition.

Read the detailed description

TELO-SCOPE is a national, multi-centre, double-blind, placebo-controlled, randomised trial which will be conducted in subjects aged >5 years with a multi-disciplinary diagnosis of pulmonary fibrosis and with age-adjusted telomere length below the 10th centile in adults; and for children (age < 16 years), a confirmed diagnosis of Dyskeratosis Congenita (DC). Consenting participants who meet all other inclusions and no exclusions will be randomised (n=50, 2:1 (danazol:placebo)) to receive danazol (maximum tolerated dose (up to 800mg daily, two-divided doses) or matched placebo, for 12 months in addition to standard of care background therapy. The primary outcome is change in telomere length at 12 months.

Being tested
Danazol, Placebo
Medical subject headings
Pulmonary Fibrosis, Dyskeratosis Congenita

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DanazolDrug

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

  • PlaceboDrug

    Matching placebo.

Study groups in NCT04638517
Study groupRoleWhat they receive
DanazolActive comparator800mg 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.
Receives: Drug: Danazol
PlaceboPlacebo comparatorMatching placebo capsules.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in absolute telomere length from baseline (base pairs)

    Telomere length will be measured in absolute terms (base pairs) using the telomere shortest length assay (TeSLA).

    Measured: 12 months

Secondary outcomes (9)

  1. Number of participants with treatment-emergent adverse events

    Measured: 12 months

  2. Number of Participants With Death or Non-Elective Hospitalisation

    Measured: 12 months

  3. Change in telomere length from baseline to 3, 6 and 9 months (base pairs)

    Measured: 3, 6 and 9 months

  4. Change in forced vital capacity (FVC) at 6 and 12 months

    FVC is measured as the volume of air exhaled during spirometry.

    Measured: 6 and 12 months

  5. Change in diffusing capacity for carbon monoxide at 6 and 12 months

    DLCO is a measurement of the of the lung's gas transfer ability.

    Measured: 6 and 12 months

  6. Change in 6-minute walk distance from baseline

    Measured: 12 months

  7. Change in Leicester cough questionnaire (LCQ) from baseline

    Measured: 12 months

  8. Change in King's Brief Interstitial Lung Disease Questionnaire (K-BILD) from baseline

    Measured: 12 months

  9. Change in Parent cough-specific quality of life (PCSQoL) from baseline

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2020
  2. Study start7 Sep 2021
  3. Primary completion16 Jan 2025
  4. Study completion16 Jan 2025

Why it stopped: Data Safety Monitoring Board recommended cessation due to futility

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04638517
Sponsor's protocol ID
TELO-SCOPE
Status last verified
Jan 2025
First submitted
4 Nov 2020
Last updated
5 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data will be analysed and shared with collaborators with the plan to publish the results.

Publications

  • Mackintosh JA, Pietsch M, Lutzky V, Enever D, Bancroft S, Apte SH, Tan M, Yerkovich ST, Dickinson JL, Pickett HA, Selvadurai H, Grainge C, Goh NS, Hopkins P, Glaspole I, Reynolds PN, Wrobel J, Jaffe A, Corte TJ, Chambers DC. TELO-SCOPE study: a randomised, double-blind, placebo-controlled, phase 2 trial of danazol for short telomere related pulmonary fibrosis. BMJ Open Respir Res. 2021 Dec;8(1):e001127. doi: 10.1136/bmjresp-2021-001127.

    PubMed 34857525

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Danazol in people with Pulmonary Fibrosis and Telomere Shortening, run by The University of Queensland at 9 sites in Australia.

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 8 inclusion and 27 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: stopped early, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

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 phase mean?

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 stopped early (reason given: Data Safety Monitoring Board recommended cessation due to futility). Results are not available in the source record.

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?

Change in absolute telomere length from baseline (base pairs) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04638517, which also lists 1 linked publication.

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 5 Aug 2025.

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Clinical Trial NCT04638517 | AzTrials