A Phase 4 interventional study of Rocaltrol and Dexamethasone in Immune Thrombocytopenia, sponsored by Shandong University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-09-09.
Sponsored by Shandong University · Phase 4, Interventional, and Treatment
The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of vitamin D combining with high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).
The investigators anticipate to undertaking a prospective, multicenter, randomised controlled trial of 60 ITP adult patients. One part of the participants are randomly selected to receive vitamin D (given Rocaltrol orally at a dose of 0.25 μg per day for 1 month), combining with dexamethasone (given orally at a dose of 40 mg per day for 4 days, two-cycles with an interval of 10 days); the others are selected to receive high-dose of dexamethasone treatment plus placebo. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Serum calcium and creatinine are monitored. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of vitamin D combining with high-dose dexamethasone therapy for the treatment of adults with ITP.
697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.
This study's planned enrollment of 60 is close to the median of 55 across 472 interventional studies indexed under Thrombocytopenia.
Browse Thrombocytopenia studies →Shandong University is the lead sponsor of 284 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
Rocaltrol 0.25 μg once per day, 1 month; HD-DXM (orally at 40 mg daily for 4d )
Drug: Rocaltrol · Drug: Dexamethasone
HD-DXM (orally at 40 mg daily for 4d )
Drug: Rocaltrol
Rocaltrol 0.25 μg daily for 1 month; HD-DXM (orally at 40 mg daily for 4d )
Also known as: Calcitriol Soft Capsules
HD-DXM (orally at 40 mg daily for 4d )
Sustained response to ITP treatments
Percentage of patients maintaining PLT count over 30\*10\^9 without bleeding
Time frame: 3 months after treatment started
Evaluation of platelet response
Complete response (CR)： A platelet count ≥ 100 \* 10\^9/L measured on two occasions \> 7 days apart and the absence of bleeding. Response (R)： A platelet count ≥ 30 \* 10\^9/L and a greater than two fold increase in platelet count from baseline measured on two occasions \> 7 days apart and the absence of bleeding. No response (NR)： A platelet count \< 30 \* 10\^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.
Time frame: 3 months after treatment started
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Shandong University