Thrombocytopenia Clinical Trial
— SSCIOfficial title:
Sirolimus in Patients With Connective Tissue Disease Related Thrombocytopenia (CTD-TP): a Single-arm, Open-label Clinical Trial in China
Verified date | December 2018 |
Source | Peking Union Medical College Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
We have designed a single-arm, open-label study of sirolimus in Chinese patients with refractory CTD-TP unresponsive to, or intolerant of, conventional medications at Peking Union Medical College Hospital (PUMCH). Patients received oral sirolimus at a starting dose of 2 mg per day for 3 days and a sequential dose of 1mg per day, with dose adjusted according to tolerance and to maintain a therapeutic range of 6-15 ng/mL. Patients were treated with sirolimus for more than 6 months. Safety outcomes and the efficacy endpoints were assessed in all patients who received at least one dose of treatment.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | September 30, 2019 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patients with refractory CTD-TP unresponsive to, or intolerant of, conventional medications at Peking Union Medical College Hospital. Exclusion Criteria: - new diagnosed CTD-IT patients |
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Bleeding Events with treatment-related adverse events | 6 months | ||
Primary | Number of participants with complete remission of platelet count | Complete remission of platelet count means the platelet count over 100X10^9/L. every participants will take CBC as their screening times. | 6 months | |
Secondary | Number of participants with partial remission of platelet count | Partial remission of ITP means that the platelet count was less than 100X10^9/L, but it was more than two times higher than that before treatment. | 6 months |
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