A Phase 3 interventional study of Romiplostim and Placebo in Immune Thrombocytopenia, sponsored by Kyowa Kirin China Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-29.
Sponsored by Kyowa Kirin China Pharmaceutical Co., Ltd. (formerly part of Kyowa Kirin Co., Ltd.) · Phase 3, Interventional, and Treatment
The objective is to evaluate the efficacy and safety of romiplostim for injection in adlut subjects with persistent or chronic primary immune thrombocytopenia (ITP).
503 studies on the registry are indexed under Purpura, Thrombocytopenic, Idiopathic; 158 are open to participants now.
This study's enrollment of 203 is above the median of 58 across 376 interventional studies indexed under Purpura, Thrombocytopenic, Idiopathic.
Browse Purpura, Thrombocytopenic, Idiopathic studies →Kyowa Kirin China Pharmaceutical Co., Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.
First submitted before Kyowa Kirin China Pharmaceutical Co., Ltd. left Kyowa Kirin Co., Ltd..
Counted across the registry records on this site, refreshed daily.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects received placebo for injection treatment will be administered subcutaneously once a week
Drug: Placebo
Subjects received Romiplostim for injection treatment will be administered subcutaneously once a week
Drug: Romiplostim
Number of weeks in which the platelet response counts increase above 50×10^9/L
Time frame: 6 weeks
Proportion of subjects whose platelet counts relative to the baseline increase ≥ 20×10^9/L
Time frame: 6 weeks
Proportion of subjects who have received emergency treatment to increase the platelet counts
Time frame: 6 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Sep 2015 to primary completion in Feb 2017, 17 months.
Of 41 industry-sponsored phase 3 interventional studies under Purpura, Thrombocytopenic, Idiopathic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 45. This study's 17 months is below that.
Counting every sponsor, half of 57 studies reached it within 28 months; a quarter within 22 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Romiplostim
Purpura, Thrombocytopenic, Idiopathic →
Kyowa Kirin China Pharmaceutical Co., Ltd. →