A Phase 4 interventional study of Rituximab and Rituximab in Purpura, Thrombocytopenic, Idiopathic and Immune Thrombocytopenia, sponsored by Shandong University. Completed at 1 site in China. Open to participants aged 10 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-08-23.
Sponsored by Shandong University · Phase 4, Interventional, and Treatment
Among 27 studies testing rituximab in Purpura, Thrombocytopenic, Idiopathic — 5 open to participants now, 5 under way, 2 of them phase 3. Rituximab · Purpura, Thrombocytopenic, Idiopathic.
Among the 27 studies testing rituximab in Purpura, Thrombocytopenic, Idiopathic, this one is the 13th largest by enrollment, is one of 2 that started in 2010, is one of 2 in phase 4, and was the 21st registered.
503 studies on the registry are indexed under Purpura, Thrombocytopenic, Idiopathic; 158 are open to participants now.
Browse Purpura, Thrombocytopenic, Idiopathic studies →5 of the 27 studies testing rituximab in Purpura, Thrombocytopenic, Idiopathic are open now, in 4 countries. Recruiting first, the newest first:
The First Affiliated Hospital of Soochow University · Sites in China
Assistance Publique - Hôpitaux de Paris · Sites in France
New York Medical College · Sites in United States
Nahda University · Sites in Egypt
Ostfold Hospital Trust
By country, each count listing its studies:
Rituximab: first FDA approval 1997 (RITUXAN), first EMA approval 1998. What it is approved for, and how studies give it, is on its page →
Of the 102 Purpura, Thrombocytopenic, Idiopathic studies recruiting now, 48 (47%) set no upper age limit and 42 (41%) stop at 75 or younger; 27 take children under 18; 4 take healthy volunteers.
This study: 10 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
27 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 12 · Phase 3 10 · Phase 4 2
First in 2000; this study’s year is marked. 2 started in 2010.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 62 is close to the median of 58 across 376 interventional studies indexed under Purpura, Thrombocytopenic, Idiopathic.
Median enrollment 60 across the 27 interventional studies. Of the 17 that completed or were terminated, 3 (18%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 27 have an industry lead sponsor. The 10 most frequent:
Shandong University is the lead sponsor of 292 studies on the registry; 60 are open to participants now.
38 studies in Purpura, Thrombocytopenic, Idiopathic by Shandong University: 2 open now, 3 under way, 1 of them phase 3. Of 11 finished, 0 (0%) have results posted.
Among the 38 studies in Purpura, Thrombocytopenic, Idiopathic by Shandong University, this one is the 13th largest by enrollment of the 30 interventional ones that give a count, is one of 2 that started in 2010, is one of 6 in phase 4, and was the 25th registered.
Shandong University’s Purpura, Thrombocytopenic, Idiopathic studies by the year they started, since 2005.
2 of the studies testing rituximab in Purpura, Thrombocytopenic, Idiopathic that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05338190Phase 3Assistance Publique - Hôpitaux de ParisEfficacy and Safety of Subcutaneous Belimumab or Placebo in Addition of Rituximab in Persistent or Chronic Immune Thrombocytopenia | 2026-11-14 |
| NCT07206823The First Affiliated Hospital of Soochow UniversityEfficacy and Safety of Romiplostim N01 Combined With Rituximab in Patients With Oral TPO-RA-Refractory Primary Immune Thrombocytopenia | 2027-02-28 |
Among the 27 studies testing rituximab in Purpura, Thrombocytopenic, Idiopathic, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Shandong University’s 38 in Purpura, Thrombocytopenic, Idiopathic:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The project was undertaking by Qilu Hospital of Shandong University in China. In order to compare the efficacy, safety and response duration of different dose of rituximab in patients primary immune thrombocytopenia(pITP).
62 patients with pITP who had failed to respond to glucocorticosteroids were randomly divided into 2 groups: group A(n = 32) and group B(n = 30). In group A, Rituximab was given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22). In group B, Rituximab was given with a single dose of 375mg/m2. The clinical effect, onset time, duration of efficacy and adverse reactions were observed to compare the efficacy and safety of two different plans.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In group A, Rituximab was given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22).
Drug: Rituximab
In group B, Rituximab was given with a single dose of 375mg/m2
Drug: Rituximab
Evaluation of platelet response(continuous response rate)
Complete Response:a sustained (≥ 3 months) platelet count≥100×10\^9/L;response: a sustained (≥ 3 months) platelet count ≥ 30×10\^9/L without recurrence of thrombocytopenia;No response (NR): 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: up to 1 year per subject
therapy associated adverse events
The number and frequency of therapy associated adverse events
Time frame: up to 1 year per subject
Plan to share: No
Ran from Jan 2010 to primary completion in Dec 2015, 71 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rituximab
Purpura, Thrombocytopenic, Idiopathic →