At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 27 enrolled
Drug / intervention
STI571drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-centre, Open-label, Proof of Concept (PoC) Study to Evaluate the Efficacy and Tolerability of STI571 for the Treatment of Fibrosis in Patients With Systemic Sclerosis
In Brief
A Phase 2 clinical trial evaluating STI571 for Systemic Sclerosis, Scleroderma. Completed, enrolled 27 participants across 7 sites in 5 countries.
Detailed Summary
This study investigates the efficacy and safety of STI571 for the treatment of fibrosis in participants with systemic sclerosis. Other purposes of the study were to investigate whether STI571 is effective in improving lung functions and other test results called biomarkers. Whether STI571 is well-absorbed in systemic sclerosis participants' gut was also investigated by testing the drug level in the blood (pharmacokinetics).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Sclerosis, Scleroderma
CountriesGermany, Italy, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2008
First PostedFeb 2008
Primary CompletionJan 2010
TodayJul 2026
First PostedFeb 12, 2008
Enrollment StartJan 2, 2008
Primary CompletionJan 13, 2010
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 18.4 years ago
Interventions
STI571drug
STI571 tablets taken orally once a day