NCT00613171

Efficacy and Tolerability of STI571 (Imatinib Mesylate) for the Treatment of Fibrosis in Participants With Systemic Sclerosis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Systemic Sclerosis, Scleroderma

Interventions

Type	Name	Description
DRUG	STI571	STI571 tablets taken orally once a day

Timeline

• Start date: 2008-01-02
• Primary completion: 2010-01-13
• Completion: 2010-01-13
• First posted: 2008-02-12
• Last updated: 2021-07-07
• Results posted: 2021-05-21

Locations

7 sites across 5 countries: United States, Germany, Italy, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study