Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-28 @ 12:38 PM
Study NCT ID:
NCT06051357
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2023-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proof of Concept Study to Assess the Efficacy, Safety of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006457', 'term': 'Hemoglobinuria, Paroxysmal'}], 'ancestors': [{'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2023-09-05', 'studyFirstSubmitQcDate': '2023-09-20', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in hemoglobin.', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Changes in LDH.', 'timeFrame': '12 weeks'}, {'measure': 'Changes in haptoglobin.', 'timeFrame': '12 weeks'}, {'measure': 'Changes in bilirubin.', 'timeFrame': '12 weeks'}, {'measure': 'Changes in reticulocyte counts.', 'timeFrame': '12weeks'}, {'measure': 'Changes in C3 complement fragment deposition.', 'timeFrame': '12 week'}, {'measure': 'Percentage of patients who did not receive a blood transfusion.', 'timeFrame': '12 weeks'}, {'measure': 'Number of RBC units of transfused.', 'timeFrame': '12weeks'}, {'measure': 'Incidence and severity of adverse events', 'timeFrame': '16 weeks'}, {'measure': 'Incidence of thromboembolic events.', 'timeFrame': '16 weeks'}, {'measure': 'Plasma concentration of HRS-5965.', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Paroxysmal Nocturnal Hemoglobinuria']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomized, open-label phase II clinical trial. A total of 24 patients with paroxysmal nocturnal hemoglobinuria naïve to complement inhibitor therapy were included. Subjects were treated with HRS-5965 for 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of PNH confirmed by flow cytometry with clone size ≥ 10%.\n2. Have not received complement inhibitor therapy ;\n3. LDH \\> 1.5×ULN;\n4. Hemoglobin level \\< 10 g/dL.\n\nExclusion Criteria:\n\n1. Known or suspected hereditary or acquired complement deficiency;\n2. Patients with laboratory evidence of bone marrow failure (reticulocytes \\<100x109/L; platelets \\<30x109/L; neutrophils \\<0.5x109/L);\n3. Presence or suspicion of a systemic active bacterial, viral, or fungal infection (based on judgment of the investigator) within 2 weeks prior to the first dose of HRS-5965;\n4. History of infection with capsular bacteria (e.g., meningococcus, pneumococcus, etc.)\n5. Positive of HIV, HBsAg or HCVAb.'}, 'identificationModule': {'nctId': 'NCT06051357', 'briefTitle': 'Proof of Concept Study to Assess the Efficacy, Safety of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chengdu Suncadia Medicine Co., Ltd.'}, 'officialTitle': 'An Multicenter, Randomized, Open-label Proof of Concept Study to Assess the Efficacy, Safety of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)', 'orgStudyIdInfo': {'id': 'HRS-5965-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group A', 'interventionNames': ['Drug: HRS-5965 tablets']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group B', 'interventionNames': ['Drug: HRS-5965 tablets']}], 'interventions': [{'name': 'HRS-5965 tablets', 'type': 'DRUG', 'description': 'HRS-5965 tablets for 12 weeks', 'armGroupLabels': ['Treatment group A', 'Treatment group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '300020', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'The Blood Disease Hospital of the Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chengdu Suncadia Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}