Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-02-28 @ 9:32 AM
Study NCT ID:
NCT06479304
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of HCQ Plus Pred in ANA Positive ITP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006886', 'term': 'Hydroxychloroquine'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 129}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-27', 'studyFirstSubmitDate': '2024-06-22', 'studyFirstSubmitQcDate': '2024-06-27', 'lastUpdatePostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': '4 weeks', 'description': 'The percentage of participants with platelet counts higher than 30×10\\^9/L and at least twice the baseline platelet count , for at least two consecutive tests (7 days apart).'}], 'secondaryOutcomes': [{'measure': 'Complete response rate', 'timeFrame': '1 year', 'description': 'The percentage of participants with platelet counts higher than 100×10\\^9/L , for at least two consecutive tests (7 days apart).'}, {'measure': 'Duration of response', 'timeFrame': '1 year', 'description': 'Time from response to disease relapse (platelet count ≤ 30×10\\^9/L on any test or occurance of bleeding symptoms )'}, {'measure': 'Durable response rate', 'timeFrame': '1 year', 'description': 'Percentage of patients with complete remission lasting at least 6 months without any additional ITP-specific therapy'}, {'measure': 'Platelet count at each visit', 'timeFrame': '1 year', 'description': 'Average platelet count at each visit'}, {'measure': 'Time to response', 'timeFrame': '4 weeks', 'description': 'Time from starting treatment to response'}, {'measure': 'Response rate throughout the trial', 'timeFrame': '1 year', 'description': 'The percentage of response participants (platelet counts higher than 30×10\\^9/L and at least twice the baseline platelet count ) at each visit'}, {'measure': 'WHO bleeding score', 'timeFrame': '1 year', 'description': 'WHO bleeding score at each visit; World Health Organization，minimum values was 0 , means no bleeding, and maximum value was 4, means Debilitating blood loss'}, {'measure': 'Adverse reaction', 'timeFrame': '1 year', 'description': 'Adverse reaction at each visit'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Immune Thrombocytopenia With Positive ANA Antibodies']}, 'referencesModule': {'references': [{'pmid': '31794604', 'type': 'BACKGROUND', 'citation': 'Neunert C, Terrell DR, Arnold DM, Buchanan G, Cines DB, Cooper N, Cuker A, Despotovic JM, George JN, Grace RF, Kuhne T, Kuter DJ, Lim W, McCrae KR, Pruitt B, Shimanek H, Vesely SK. American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood Adv. 2019 Dec 10;3(23):3829-3866. doi: 10.1182/bloodadvances.2019000966.'}, {'pmid': '24254965', 'type': 'RESULT', 'citation': 'Khellaf M, Chabrol A, Mahevas M, Roudot-Thoraval F, Limal N, Languille L, Bierling P, Michel M, Godeau B. Hydroxychloroquine is a good second-line treatment for adults with immune thrombocytopenia and positive antinuclear antibodies. Am J Hematol. 2014 Feb;89(2):194-8. doi: 10.1002/ajh.23609. Epub 2013 Nov 20.'}, {'pmid': '35288899', 'type': 'RESULT', 'citation': 'Mejdoub S, Hachicha H, Gargouri L, Feki S, Mahfoudh A, Masmoudi H. Antinuclear antibodies in children: clinical signification and diagnosis utility. Tunis Med. 2021 Octobre;99(10):980-984.'}, {'pmid': '28416506', 'type': 'RESULT', 'citation': 'Lambert MP, Gernsheimer TB. Clinical updates in adult immune thrombocytopenia. Blood. 2017 May 25;129(21):2829-2835. doi: 10.1182/blood-2017-03-754119. Epub 2017 Apr 17.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if hydroxychloroquine (HCQ) plus prednisone (Pred) works to treat primary immune thrombocytopenia with positive anti-nuclear antibodies in adults. It will also learn about the safety of HCQ plus Pred. The main questions it aims to answer are:\n\nDoes HCQ plus Pred raise the response rate in participants, compared to Pred alone? Does HCQ plus Pred prolong the response duration in participants, compared to Pred alone? What medical problems do participants have when taking HCQ plus Pred? Researchers will compare HCQ plus Pred with Pred alone to see if HCQ plus Pred works better to treat primary immune thrombocytopenia with positive anti-nuclear antibodies.\n\nParticipants will:\n\nTake Pred every day for 6 weeks, with or without HCQ twice a day for 1 year , Visit the clinic once every 1 weeks for the first 4 weeks, and once every 2-4 weeks in the following 11 months for checkups and tests, Keep a diary of their symptoms.', 'detailedDescription': 'Primary immune thrombocytopenia (Primary immune thrombocytopenia, ITP) is an acquired autoimmune hemorrhagic disease characterized by a decreased peripheral platelet count and an increased risk of bleeding. It has been reported that 33.3% -39.2% of ITP patients have positive antinuclear antibodies (ANA) in the course of the disease.In the meantime, they do not meet the diagnostic criteria for rheumatic diseases such as lupus erythematosus(SLE). ITP patients with positive ANA are prone to relapse and chronicity. Therefore, it is necessary to explore new clinical treatments to attain long-term remission in these patients.\n\nHydroxychloroquine (HCQ) has immune modulating role on a variety of immune cells.A clinical trial enrolled immune thrombocytopenia secondary to SLE, and ITP with positive anti-nuclear antibodiy (ANA) were treated with HCQ combined with glucocorticoids. The results showed an overall response rate of 60% (24 / 40), including 18 continuous complete response (CR) and 6 continuous response (R), and some patients had continued elevated platelet counts 3 months after treatment initiation. The above studies illustrate that HCQ contributes to the treatment of chronic ITP, especially as a long-term therapeutic agent with low economic burden and good tolerance. In conclusion, it can be seen that HCQ and prednisone have complementary mechanism of action and complementary time window, which can be used as a combination for the treatment of ITP select.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age is above 75 years old, or participants with uncontrolled hypertension and diabetes mellitus at the age between 15-75 years old, gender is unlimited.\n2. Before randomization, the clinical diagnosis is primary immune thrombocytopenia. The platelet count is less than 30×10\\^9 / L within 1 week before enrollment, or platelet count is less than 50×10\\^9 / L with bleeding symptoms within 1 week before enrollment.\n3. The antinuclear antibody is positive.\n4. Other autoantibodies (mainly including dsDNA antibodies, SSA, SSB, RNP, β 2-GP, ACA, ANCA) are negative.\n5. Prothrombin time does not exceed ± 3s of the normal value ranget, activated partial thrombin time is not outside normal range ± 10s; no history of coagulopathy except ITP.\n6. Understand the study procedures and sign the written informed consent form.\n\nExclusion Criteria:\n\n1. Secondary thrombocytopenia caused by myelodysplastic syndrome, immune diseases such as systemic lupus erythematosus, early aplastic anemia, atypical reanemia, antiphospholipid syndrome, thrombotic thrombocytopenic purpura and various other causes.\n2. The participant has experienced any arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism), or clinical symptoms and medical history indicate thrombophilia.\n3. Congestive heart disease, including New York Heart Association (NHYA) Grade III / IV, occurred within 3 months prior to screening, arrhythmia requiring medication or myocardial infarction, or arrhythmia known to increase the risk of thrombotic events (such as atrial fibrillation), or corrected QT interval (QTc) is longer than 450 ms, or QTc\\> 480 ms in paricipants with bundle branch block.\n4. With severe hemorrhage (intracranial hemorrhage) or coagulation dysfunction (INR and APTT\\> 125% upper limit of normal).\n5. With severe digestive tract diseases affecting drug absorption.\n6. With serious mental illness patient.\n7. Having participated in other clinical trials within 3 months prior to screening.\n8. Having received any immunomodulatory medication for other diseases 3 months before screening.\n9. Having received any medication affecting platelet function ( Including but not limited to aspirin, aspirin-containing complexes, clopidogrel, salicylates, and / or non-steroidal anti-inflammatory drugs NSAIDs ) or anticoagulant therapy for over consecutive 3 days within 2 weeks before screening.\n10. With Glucose-6-phosphate dehydrogenase deficiency.\n11. With retinal or visual field changes caused by 4-aminoquinoline compounds.\n12. Being allergic to 4-aminoquinoline compounds.\n13. Having evidence of Human Immunodeficiency Virus (HIV)/ hepatitis C virus(HCV)/ hepatitis B virus(HBV) infection (HIV antibody or HCV antibody is positive, HBV surface antigen is positive, or HBV surface antigen is negative but HBV-DNA indicating viral replication.\n14. Glutamate transaminotransferase (ALT) or glutamate transaminase (AST) is higher than 1.5 times the upper limit of normal value (ULN), or total bilirubin or blood creatinine is higher than 1.2 times the ULN.\n15. With liver cirrhosis or portal hypertension.\n16. With evidence of malignant tumor activity, or receiving anti-tumor treatment within 5 years prior to the screening.\n17. Addicted to alcohol or drugs.\n18. Participants being pregnant or lactating, or with potential fertility, reluctance to use effective contraception within the entire trial cycle and within 28 days after the end of the trial (or within 28 days after premature withdraw).'}, 'identificationModule': {'nctId': 'NCT06479304', 'briefTitle': 'The Efficacy and Safety of HCQ Plus Pred in ANA Positive ITP', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'The Efficacy and Safety of Hydroxychloroquine Plus Prednisone in Antinuclear Antibody-positive Patients With Primary Immune Thrombocytopenia-- The Multicenter, Randomized, Open-lable Clinical Trial', 'orgStudyIdInfo': {'id': 'B2024-028R2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HCQ plus Pred group', 'description': 'This group is experiment group. Participants will take Pred every day for 6 weeks with HCQ twice a day for 1 year', 'interventionNames': ['Drug: Hydroxychloroquine Oral Tablet', 'Drug: Prednisone tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Pred group', 'description': 'This group is control group. Participants will take Pred every day for 6 weeks.', 'interventionNames': ['Drug: Prednisone tablet']}], 'interventions': [{'name': 'Hydroxychloroquine Oral Tablet', 'type': 'DRUG', 'otherNames': ['Hydroxychloroquine'], 'description': 'Hydroxychloroquine is taken at the dose of 0.1g / dose, twice a day for 1 year, regardless of food intake.', 'armGroupLabels': ['HCQ plus Pred group']}, {'name': 'Prednisone tablet', 'type': 'DRUG', 'otherNames': ['Prednisone'], 'description': 'Prednisone is given at the dose of 1mg/kg every morning after meals for 2 weeks ( if platelet count does not recover higher than 30×10\\^9/L after 2 weeks, prednisone will be given at the dose for 2 more weeks ), then tapering off.', 'armGroupLabels': ['HCQ plus Pred group', 'Pred group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lili Ji', 'role': 'CONTACT', 'email': 'ji.lili@zs-hospital.sh.cn', 'phone': '086-021-64041990'}, {'name': 'Yunfeng Cheng', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shanghai Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200094', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongjuan Lu', 'role': 'CONTACT', 'email': '13564618950@163.com', 'phone': '13564618950'}], 'facility': 'Zhongshan Wusong Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '201508', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yunfeng Cheng', 'role': 'CONTACT', 'email': 'yfcheng@fudan.edn.cn', 'phone': '15921398238'}], 'facility': 'Shanghai Jinshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '201700', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fanli Hua', 'role': 'CONTACT', 'email': 'hua_fanli@fudan.edu.cn', 'phone': '18116017032'}], 'facility': 'Zhongshan Qingpu Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '999077', 'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Gregory Cheng', 'role': 'CONTACT', 'email': 'gregorycheng@um.edu.mo', 'phone': '852-60269018'}], 'facility': 'Health and Humanity Research Centre, Hongkong, China.', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '999078', 'city': 'Macao', 'status': 'RECRUITING', 'country': 'Macau', 'contacts': [{'name': 'Gregory Cheng', 'role': 'CONTACT', 'email': 'gregorycheng@um.edu.mo', 'phone': '852-60269018'}], 'facility': 'Dr. Stanley Ho Medical Foundation', 'geoPoint': {'lat': 22.20056, 'lon': 113.54611}}, {'zip': '999078', 'city': 'Macao', 'status': 'RECRUITING', 'country': 'Macau', 'contacts': [{'name': 'Gregory Cheng', 'role': 'CONTACT', 'email': 'gregorycheng@um.edu.mo', 'phone': '852-60269018'}], 'facility': 'University Hospital, Macau University of Science and Technology.', 'geoPoint': {'lat': 22.20056, 'lon': 113.54611}}], 'centralContacts': [{'name': 'Lili Ji', 'role': 'CONTACT', 'email': 'ji.lili@zs-hospital.sh.cn', 'phone': '86-021-64041990'}], 'overallOfficials': [{'name': 'Yunfeng Cheng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Zhongshan Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'IPD information will become available starting 6 months after publication, for 1 year.', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yunfeng Cheng', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, {'name': 'Shanghai Jinshan Hospital', 'class': 'OTHER'}, {'name': 'Zhongshan Qingpu Hospital, Fudan University', 'class': 'UNKNOWN'}, {'name': 'Zhongshan Wusong Hospital, Fudan University', 'class': 'UNKNOWN'}, {'name': 'Macau University of Science and Technology Hospital', 'class': 'OTHER'}, {'name': 'Health and Humanity Research Centre, Hongkong', 'class': 'UNKNOWN'}, {'name': 'Dr. Stanley Ho Medical Foundation, Macau', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Institute of Clinical Science, Zhongshan Hospital', 'investigatorFullName': 'Yunfeng Cheng', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}