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The efficacy and safety of sirolimus for the treatment of Systemic Sclerosis: a single-arm, single-center pilot study

The efficacy and safety of sirolimus for the treatment of Systemic Sclerosis: a single-arm, single-center pilot study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030370
Enrollment
Unknown
Registered
2020-02-29
Start date
2020-03-01
Completion date
Unknown
Last updated
2020-03-02

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

Conditions

Systemic Sclerosis

Interventions

Sponsors

The First Affiliated Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years, gender unlimited. 2. Signed the informed consent before the test. 3, The patients diagnosed as SSc by satisfying 2013 ACR classification criteria for SSc. 4. TSS15 >= 15; 5. Medsger severity score >= 2; 6. Prednisone dose<10mg/d and the dose has maintained for over 30 days.

Exclusion criteria

Exclusion criteria: 1. The patients who use CYC,MMF,FK506, CsA,LEF,glucocorticoids(>0.8mg/Kg*d),IVIG or plasma exchange within 30 days before the test,will be excluded. 2. Patients with malignant tumor, immune deficiency, uncontrolled severe infection or active peptic ulcer. 3. Pregnant women,lactating women and men or women with family planning in the next 12 months. 4. Patients with a history of allergy to the test drug. 5. Patients with active hepatitis or a history of serious liver disease. 6. Patients with serious heart, liver, kidney or other important organs lesions. 7. Patients whom the researchers don't think suitable for this study.

Design outcomes

Primary

MeasureTime frame
Medsger Severity Score;

Countries

China

Contacts

Public ContactPingting Yang

The First Affiliated Hospital of China Medical University

yangpingtingting@163.com+86 13904003875

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026