Systemic Sclerosis (Scleroderma)Phase 1/2TRANOSNCT00226889
Treatment of Early Systemic Sclerosis by Bosentan
A Phase 1/2 study testing bosentan in people with Systemic Sclerosis (Scleroderma), run by Rikshospitalet University Hospital at 1 site in Norway.
Trial summary
Systemic sclerosis (ssc) is characterised by extensive tissue fibrosis. Using drugs that are capable of inhibiting fibroblast activity may be beneficial if administrered early in the disease course. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Sclerosis (Scleroderma)
- What is being tested?
- bosentan
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2005to Jun 2009
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Early systemic sclerosis
Who cannot join
- Age > 70 or < 18
- Pregnancy
- Nursing
- HIV
- Hb < 8.5 g/l
- Systolic blood pressure < 85 mmHg
Show all 10Show fewer
- Lack of compliance
- Liver disease
- Hypersensitivity to bosentan
- Concurrent us of glibenclamide, ciclosporine A or tacrolimus -
Trial locations and contacts
1 site in 1 country.
About this study
Systemic sclerosis (ssc) is characterised by extensive tissue fibrosis. Using drugs that are capable of inhibiting fibroblast activity may be beneficial if administrered early in the disease course. Thirty adult patients with early SSc will be treated with the endothelin-1 antagonist bosentan for 6 months.Disease progression will be assessed.
Read the detailed description
Systemic sclerosis (SSc) is characterised by obliterative vasculopathy and extensive fibrosis. The accumulation of extracellular components in the extracellular matrix is mostly due to increased activity og tissue fibroblasts. The proliferation and hyperactivity of the fibroblasts may be caused by enhanced production of several cytokins, among them endothelin-1.The activity of endothelin-1 has been shown to be increased both in the circulation and within skin lesions. Endothelin-1 has several distinct properties, among them profibrotic activity, inflammatory and vasoconstriction.Thus, the actions induced by endothelin-1 may be a potensial target for the therapy of SSc.
Thirty patients with early SSc, that is of less than 12 months duration will be offered six months of treatment with the oral dual endothelin-1 antagonist bosentan. Assessment of disease progression will be performed at 3, 6, 9. 12 and 24 months using clinical, histological and immunohistochemical methods.
- Conditions
- Systemic Sclerosis (Scleroderma)
- Being tested
- bosentan
- Keywords
- Scleroderma, Fibrosis, Therapy, Bosentan, Endothelin-1
- Medical subject headings
- Scleroderma, Systemic, Scleroderma, Diffuse, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bosentanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall clinical progression
Degree of deposition of ET-1 in skin
Secondary outcomes (2)
Development of extradermatological manifestations
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionJan 2009
- Study completionJun 2009
Why it stopped: failure of recruiting a sufficient number of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Sclerosis (Scleroderma)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rikshospitalet University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jan T Gran, Professor, Study director, department of rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226889
- Sponsor's protocol ID
- EUDRACTNR.2004-000650-23
- Acronym
- TRANOS
- Status last verified
- Mar 2006
- First submitted
- 23 Sep 2005
- Last updated
- 12 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Early Systemic Sclerosis by Bosentan
- ClinicalTrials.gov ID
- NCT00226889
- Acronym / sponsor ID
- TRANOS / EUDRACTNR.2004-000650-23
- Conditions
- Systemic Sclerosis (Scleroderma)
- Keywords
- Scleroderma, Fibrosis, Therapy, Bosentan, Endothelin-1
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: failure of recruiting a sufficient number of patients
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rikshospitalet University HospitalUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jan 2009
- Study completion
- Jun 2009
- First posted
- 27 Sep 2005 (estimated)
- 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.
Systemic sclerosis (ssc) is characterised by extensive tissue fibrosis. Using drugs that are capable of inhibiting fibroblast activity may be beneficial if administrered early in the disease course. Thirty adult patients with early SSc will be treated with the endothelin-1 antagonist bosentan for 6 months.Disease progression will be assessed.
Detailed description
Systemic sclerosis (SSc) is characterised by obliterative vasculopathy and extensive fibrosis. The accumulation of extracellular components in the extracellular matrix is mostly due to increased activity og tissue fibroblasts. The proliferation and hyperactivity of the fibroblasts may be caused by enhanced production of several cytokins, among them endothelin-1.The activity of endothelin-1 has been shown to be increased both in the circulation and within skin lesions. Endothelin-1 has several distinct properties, among them profibrotic activity, inflammatory and vasoconstriction.Thus, the actions induced by endothelin-1 may be a potensial target for the therapy of SSc.
Thirty patients with early SSc, that is of less than 12 months duration will be offered six months of treatment with the oral dual endothelin-1 antagonist bosentan. Assessment of disease progression will be performed at 3, 6, 9. 12 and 24 months using clinical, histological and immunohistochemical methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Early systemic sclerosis
Key exclusion criteria (10 listed)
- Age > 70 or < 18
- Pregnancy
- Nursing
- HIV
- Hb < 8.5 g/l
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 |
|---|---|---|
| bosentan | Drug | – |
Primary outcome
Overall clinical progression
Degree of deposition of ET-1 in skin
2 secondary outcomes
Development of extradermatological manifestations
Quality of life
Results and safety
The study was stopped early (reason given: failure of recruiting a sufficient number of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2009.
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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.
Jan T Gran, Professor study director
department of rheumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing bosentan in people with Systemic Sclerosis (Scleroderma), run by Rikshospitalet University Hospital at 1 site in Norway.
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 1 inclusion and 10 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 12 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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. 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 stopped early (reason given: failure of recruiting a sufficient number of patients). 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?
Overall clinical progression. The study lists 2 primary outcomes in all. 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 12 Jun 2009.