Bosentan DU

A prospective, multicenter, single arm, open-label, phase III study to assess the safety and efficacy of bosentan in patients with digital ulcers associated with systemic sclerosis (SSc)

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222130

Enrollment

Registered

2013-07-01

Start date

2013-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digital ulcers associated with systemic sclerosis

Interventions

investigational material(s) Generic name etc : Ro47-0203 / ACT-050088 INN of investigational material : Bosentan Therapeutic category code : 219 Other cardiovascular agents Dosage and Administration f

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male and female patients aged 18 years or older who currently have or had an SSc-related digital ulcer within the last 5 years

Exclusion criteria

Exclusion criteria: Digital ulcers associated with a condition other than SSc. Definitely diagnosed with PAH before starting the study treatment. etc.

Design outcomes

Primary

Measure	Time frame
Safety and tolerability endpoints ECG,Vaital Sign,Blood samples	—

Secondary

Measure	Time frame
the change of digital ulcers	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026