A Phase 1/2 interventional study of Glycosides Of Tripterygium Wilfordii Hook(GTW) and Sulfotanshinone Sodium Injection in Henoch-Schönlein Purpura Nephritis, sponsored by Henan University of Traditional Chinese Medicine. Status unknown at 2 sites in China. Open to participants aged 2 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-19.
Sponsored by Henan University of Traditional Chinese Medicine · Phase 1/2, Interventional, and Treatment
Among 16 studies in Purpura with a site in China — 4 open to participants now, 4 under way, 2 of them phase 3. Purpura · China.
Among the 16 studies in Purpura with a site in China, this one has the largest planned enrollment, is the only one that started in 2014, is one of 2 in phase 1/2, and was the 9th registered.
45 studies on the registry are indexed under Purpura; 4 are open to participants now.
Browse Purpura studies →4 of the 16 studies in Purpura with a site in China are open now. Recruiting first, the newest first:
Takeda · Sites in China, United States, Australia and 12 more countries
Capital Institute of Pediatrics, China · Sites in China
Takeda · Sites in China, United States, Australia and 15 more countries
CASI Pharmaceuticals, Inc. · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 4 Purpura studies recruiting now, 2 (50%) set no upper age limit and 2 (50%) stop at 75 or younger; 1 take children under 18; 0 take healthy volunteers.
This study: 2 Years to 18 Years · all sexes · healthy volunteers too.
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16 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 2 · Phase 3 11 · Phase 4 2
First in 2006; this study’s year is marked. 1 started in 2014.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 500 is above the median of 79 across 34 interventional studies indexed under Purpura.
Median enrollment 137 across the 16 interventional studies. Of the 7 that completed or were terminated, 3 (43%) have results posted.
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6 of 16 have an industry lead sponsor. The 9 most frequent:
Henan University of Traditional Chinese Medicine is the lead sponsor of 55 studies on the registry; 31 are open to participants now.
Henan University of Traditional Chinese Medicine has 1 study filed under Purpura — fewer than ten, so there is no comparison to draw.
1 of the studies in Purpura with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07315191Capital Institute of Pediatrics, ChinaFinerenone Therapy for Pediatric HSPN With Mild Proteinuria | 2027-10-31 |
Among the 16 studies in Purpura with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The purpose of this study is to determine the optimum dosage and application method of Glycosides Of Tripterygium Wilfordii Hook(GTW) for Henoch-Schönlein Purpura Nephritis(HSPN) in children, and develop into the normal treatment protocols for Henoch-Schönlein Purpura Nephritis in children.
Based on Chinese Eleventh Five-year Plan for Science and Technology Program, this study follows a large-sample multicenter centerrandom open-label controlled perspective method, enrolls HSPN children with hematuria associated with proteinuria and isolated proteinuria from 2 to 18 years of age, classifys five traditional Chinese medicine patterns of syndrome: wind-heat complicated with blood stasis, blood-heat complicated with blood stasis, yin deficiency complicated with blood stasis, both qi and yin deficiency complicated with blood stasis,damp-heat complicated with blood stasis. For TCM group,according to the severity of HSPN, stepped treatment should be taken. The initial dosage of GTW for severe HSPN is 2mg/kg/d, continued with 1.5mg/kg/d and 1mg/kg/d; The initial dosage of GTW for light HSPN is 1.5mg/kg/d, continued with 1mg/kg/d. On the above base, the comprehensive treatment are taken combined with TCM syndrome differentiation, medicated with Sulfotanshinone Sodium Injection.For controlled group,the treatment for severe HSPN is prednisone combined with heparin plus lotensin and dipyridamole tablets;for light HSPN is heparin plus lotensin and dipyridamole tablets.12 weeks after treatment, the third-party statistics evaluate the efficacy and effect,and a follow-up lasting 36 weeks will go on.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Light HSPN:1.Glycosides Of Tripterygium Wilfordii Hook(GTW): initial dosage is 1.5mg/kg/d(4 weeks),continued with 1mg/kg/d(8 weeks),12weeks in total. Severe HSPN:1.GTW:the initial dosage is 2mg/kg/d(2 weeks), continued with 1.5mg/kg/d(2 weeks) and 1mg/kg/d(8 weeks); 12weeks in total. On the above base,Sulfotanshinone Sodium Injection(1mg/kg/d,2weeks) and Qingrezhixue granules(a nosocomial preparation) combined with Chinese herbs(12weeks) based on TCM syndrome differentiation are taken at the same time.
Drug: Glycosides Of Tripterygium Wilfordii Hook(GTW) · Drug: Sulfotanshinone Sodium Injection · Drug: Chinese herbs based on syndrome differentiation
Light HSPN:1.Lotensin: 5-10mg/d,12weeks; 2.Low Molecular Weight Heparin(LMWH):100u/kg,2weeks;3.Dipyridamole:3mg/kg/d,Tid,12weeks.4.Chinese medicine placebo,12weeks. Severe HSPN:Add pednisone on the treatment of Light HSPN,and gradually reduce the dosage in 12 weeks,the initial dosage is 2mg/kg/d(maximum to 30mg,4 weeks),continue to reduce the dosage until discontinued（Reduce the dosage at the rate of 5mg every other day in 4-8 weeks，then reduce the dosage at the rate of 5-10mg per week in 8-12weeks）
Drug: Prednisone Acetate Tablets · Drug: Benazepril Hydrochloride Tablets · Drug: Low Molecular Weight Heparin Calcium Injection · Drug: Dipyridamole Tab 25 MG · Drug: Chinese medicine placebo
For severe HSPN GTW is 2mg/kg/d for the first 2 weeks , continued with 1.5mg/kg/d (maximum to 90mg/d) for another 2 weeks; For light HSPN GTW is 1.5mg/kg/d(maximum to 90mg/d) for 4 weeks. Both the 2 types are continued with 1mg/kg/d of GTW for another 4 weeks . Besides,Sulfotanshinone Sodium Injection,Qingrezhixue graunles,Chinese herbs by syndrome differentiation are plused at the same time
Intravenous drip of Sulfotanshinone Sodium Injection with the dosage of 1mg/kg/d(maximum to 50mg), combined with 100-250ml 5% Glucose Solution (G.S) for 2 weeks in both the light and serious type of TCM group.
For both the light and serious type of HSPN in TCM group,five traditional Chinese medicine patterns of syndrome are classified on the main pathogenesis "Blood Stasis": based on Qingre Zhixue granule,for wind-heat complicated with blood stasis, add Forsythia, Honeysuckle,;for blood-heat complicated with blood stasis,add Buffalo horn,Comfrey; for yin deficiency complicated with blood stasis, add Rhizoma anemarrhenae,Cortex phellodendri;for both qi and yin deficiency complicated with blood stasis,add Astragalus, Heterophylla;for damp-heat complicated with blood stasis,add Scutellaria baicalensis,Lalang Grass Rhizome.
Prednisone Acetate Tablets are necessary for serious HSPN in controlled group,the initial dosage is 2mg/kg/d(maximum to 30mg,4 weeks),continue to reduce the dosage until discontinued（Reduce the dosage at the rate of 5mg every other day in 4-8 weeks，then reduce the dosage at the rate of 5-10mg per week in 8-12weeks）
In controlled group, Benazepril Hydrochloride Tablets are used for both the light and serious type with the dosage of 5-10mg/d(10mg/d for children with weight above 30kg) ,12 weeks in total.
Also known as: Lotensin
In controlled group,Low Molecular Weight Heparin Calcium Injection are used for both the light and serious type with the dosage of 100u/kg/d by hypodermic injection for 2 weeks
In controlled group,Dipyridamole Tab 25 MG are used for both the light and serious type of HSPN with the dosage of 3mg/kg/d ,3 times a day,12 weeks in total.
Also known as: Persantine
In controlled group,take a potential necessary for patients who come to the hospital of TCM to take traditional Chinese medicine in consideration, we add the traditional Chinese medicine placebo in controlled group.
24-hour urinary protein quantity
24-hour urinary protein is the most important and direct indicators of therapeutic effect,so this clinical lab index should be reccord at every point during treatment and follow-up,17 times in total.
Time frame: Changes in the quantity of urinary protein at week 1、week2、week 4、week6、week8、week10 and week12 of the treatment phase and at week16、week20、week24、week28、week32、week36、week40、week44、week48 of the follow-up phase compared with baseline
Urine red blood cells
Compared to 24-hour urinary protein,urine red blood cells count is a secondary indicator to reflect therapeutic effect because urine red blood cells recede more slowly than protein,this clinical lab index should also be reccorded at every point during treatment and follow-up,17 times in total.
Time frame: Changes in the quantity of urinary protein at week 1、week2、week 4、week6、week8、week10 and week12 of the treatment phase and at week16、week20、week24、week28、week32、week36、week40、week44、week48 of the follow-up phase compared with baseline
The white blood cell count(WBC) in the blood
There is a potential risk of abnormality in the blood system in terms of leukocyte counts after taking immunosuppressor or prednison. Leukocyte count should be recorded in total of 17 times during and after treatment through routine blood tests.
Time frame: Week0(before treatment),week1、week2、week4、week6、week8、week10 and week12 of the treatment phase and week16、week20、week24、week28、week32、week36、week40、week44、week48 of the follow-up phase
The platelet count(PLT) in the blood
There is a potential risk of abnormality in the blood system in terms of platelet counts after taking immunosuppressor or prednison. Platelet count should be recorded in total of 17 times during and after treatment through routine blood tests.
Time frame: Week0(before treatment),week1、week2、week4、week6、week8、week10 and week12 of the treatment phase and week16、week20、week24、week28、week32、week36、week40、week44、week48 of the follow-up phase
Glutamate alanine transferase(ALT) in the blood
There is a potential risk of dysfunction in liver after using any drug. As one of the indicators of liver damage,the test of ALT should be taken in total of 11 times during and after treatment through a liver function test by taking blood from vein.
Time frame: Week0(before treatment)，week1、week2、week4、week8、week12 of the treatment phase and week20、week28、week36、week44、week48 of the follow-up phase
Glutamate aspartate transferase(AST) in the blood
There is a potential risk of dysfunction in liver after using any drug. As one of the indicators of liver damage,the test of AST should be taken in total of 11 times during and after treatment through a liver function test by taking blood from vein.
Time frame: Week0(before treatment)，week1、week2、week4、week8、week12 of the treatment phase and week20、week28、week36、week44、week48 of the follow-up phase
Serum Creatinine(Scr)
There is a potential risk of dysfunction in kidney after using any drug. As an indicator of kidney damage,the test of Cr should be taken in total of 11 times during and after treatment through a kidney function test by taking blood from vein.
Time frame: Week0(before treatment)，week1、week2、week4、week8、week12 of the treatment phase and week20、week28、week36、week44、week48 of the follow-up phase
Blood Urea Nitrogen(BUN)
There is a potential risk of dysfunction in kidney after using any drug. As an indicator of kidney damage，the test of BUN should be taken in total of 11 times during and after treatment through a kidney function test by taking blood from vein.
Time frame: Week0(before treatment)，week1、week2、week4、week8、week12 of the treatment phase and week20、week28、week36、week44、week48 of the follow-up phase
Plan to share: Yes — We allow all the data to be made public once the trial finished
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Our data will become availiable from January,2019 and for 10 years
Started Sep 2014 (actual). Primary completion is estimated for Dec 2018, 51 months after the start.
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This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tanshinone II A sodium sulfonate
Henan University of Traditional Chinese Medicine