Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-02-27 @ 10:38 AM
Study NCT ID:
NCT00659802
Status:
COMPLETED
Last Update Posted:
2020-07-22
First Post:
2008-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase II Study of HMPL-004 in Patients With Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713167', 'term': 'Andrographis paniculata extract'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rongjunl@hmplglobal.com', 'phone': '+86 21 2067 3203', 'title': 'Dr. Rongjun Liu', 'organization': 'Hutchison Medipharma'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Low Dose HMPL-004 (1200 mg/Day)', 'description': 'HMPL-004 : HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day).', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 45, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'High Dose HMPL-004 (1800 mg/Day)', 'description': 'HMPL-004 : HMPL-004, 600 mg (3 x 200 mg) t.i.d. total of 1800 mg/day.', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 74, 'otherNumAffected': 39, 'seriousNumAtRisk': 74, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo, t.i.d.', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 45, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rectal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Ageusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gamma-glutamyl transferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hematocrit decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Edema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Basophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rectal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pilonidal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hematocrit decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '2.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With a Clinical Response at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose HMPL-004 (1200 mg/Day)', 'description': 'HMPL-004 : HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day).'}, {'id': 'OG001', 'title': 'High Dose HMPL-004 (1800 mg/Day)', 'description': 'HMPL-004 : HMPL-004, 600 mg (3 x 200 mg) t.i.d. total of 1800 mg/day.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo, t.i.d.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': "Clinical response at week 8, which is a decrease in the Mayo score from the baseline by ≥ 3 points AND ≥ 30% decrease in the Mayo score along with either a decrease in the rectal bleeding score ≥ 1 OR an absolute rectal bleeding score ≤ 1.\n\nThe full Mayo Score evaluates ulcerative colitis stage, based on four parameters: stool frequency (0-3), rectal bleeding (0-3), endoscopic evaluation (0-3) and Physician's global assessment (0-3), ranging from 0 to 12. The higher score means a higher disease activity or worse outcome.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Based on number of subjects with a non-missing value in each treatment group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Clinical Remission at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose HMPL-004 (1200 mg/Day)', 'description': 'HMPL-004 : HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day).'}, {'id': 'OG001', 'title': 'High Dose HMPL-004 (1800 mg/Day)', 'description': 'HMPL-004 : HMPL-004, 600 mg (3 x 200 mg) t.i.d. total of 1800 mg/day.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo, t.i.d.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': "The percentage of subjects exhibiting clinical remission (Mayo score ≤2 with no individual score \\>1) at week 8.\n\nThe full Mayo Score evaluates ulcerative colitis stage, based on four parameters: stool frequency (0-3), rectal bleeding (0-3), endoscopic evaluation (0-3) and Physician's global assessment (0-3), ranging from 0 to 12. The higher score means a higher disease activity or worse outcome.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Based on number of subjects with a non-missing value in each treatment group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Mucosal Healing at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose HMPL-004 (1200 mg/Day)', 'description': 'HMPL-004 : HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day).'}, {'id': 'OG001', 'title': 'High Dose HMPL-004 (1800 mg/Day)', 'description': 'HMPL-004 : HMPL-004, 600 mg (3 x 200 mg) t.i.d. total of 1800 mg/day.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo, t.i.d.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'The percentage of subjects achieving Mucosal Healing at week 8. Mucosal Healing was defined as a significant decrease from baseline in the Mayo endoscopy sub-score ≥1 and absolute score ≤1. Mayo endoscopy sub-score ranges from 0 to 12. The higher score means a higher disease activity or worse outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Based on number of subjects with a non-missing value in each treatment group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Dose HMPL-004 (1800 mg/Day)', 'description': 'HMPL-004 : HMPL-004, 600 mg (3 x 200 mg) t.i.d. total of 1800 mg/day.'}, {'id': 'FG001', 'title': 'Low Dose HMPL-004 (1200 mg/Day)', 'description': 'HMPL-004 : HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day).'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo, t.i.d.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'comment': 'One patient was incorrectly randomized and was excluded from the efficacy analyses.', 'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '11'}]}]}], 'recruitmentDetails': 'Patients were required to have mild to moderate ulcerative colitis to enter the study. Study was conducted at medical clinics and hospitals in the United States, Ukraine and Romania.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '223', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'High Dose HMPL-004 (1800 mg/Day)', 'description': 'HMPL-004 : HMPL-004, 600 mg (3 x 200 mg) t.i.d. total of 1800 mg/day.'}, {'id': 'BG001', 'title': 'Low Dose HMPL-004 (1200 mg/Day)', 'description': 'HMPL-004 : HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day).'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo, t.i.d.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.64', 'spread': '13.61', 'groupId': 'BG000'}, {'value': '44.3', 'spread': '14.5', 'groupId': 'BG001'}, {'value': '44.68', 'spread': '15.21', 'groupId': 'BG002'}, {'value': '44.87', 'spread': '14.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The demographic characteristics of the ITT population, all 224 subjects but 1 were included, are summarized.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2009-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-06', 'studyFirstSubmitDate': '2008-04-08', 'resultsFirstSubmitDate': '2019-12-09', 'studyFirstSubmitQcDate': '2008-04-15', 'lastUpdatePostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-06', 'studyFirstPostDateStruct': {'date': '2008-04-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-10-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With a Clinical Response at Week 8', 'timeFrame': '8 weeks', 'description': "Clinical response at week 8, which is a decrease in the Mayo score from the baseline by ≥ 3 points AND ≥ 30% decrease in the Mayo score along with either a decrease in the rectal bleeding score ≥ 1 OR an absolute rectal bleeding score ≤ 1.\n\nThe full Mayo Score evaluates ulcerative colitis stage, based on four parameters: stool frequency (0-3), rectal bleeding (0-3), endoscopic evaluation (0-3) and Physician's global assessment (0-3), ranging from 0 to 12. The higher score means a higher disease activity or worse outcome."}], 'secondaryOutcomes': [{'measure': 'Number of Participants With a Clinical Remission at Week 8', 'timeFrame': '8 weeks', 'description': "The percentage of subjects exhibiting clinical remission (Mayo score ≤2 with no individual score \\>1) at week 8.\n\nThe full Mayo Score evaluates ulcerative colitis stage, based on four parameters: stool frequency (0-3), rectal bleeding (0-3), endoscopic evaluation (0-3) and Physician's global assessment (0-3), ranging from 0 to 12. The higher score means a higher disease activity or worse outcome."}, {'measure': 'Number of Participants With Mucosal Healing at Week 8', 'timeFrame': '8 weeks', 'description': 'The percentage of subjects achieving Mucosal Healing at week 8. Mucosal Healing was defined as a significant decrease from baseline in the Mayo endoscopy sub-score ≥1 and absolute score ≤1. Mayo endoscopy sub-score ranges from 0 to 12. The higher score means a higher disease activity or worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of HMPL-004 in patients with active mild to moderate ulcerative colitis (UC), compared with placebo.', 'detailedDescription': 'This is a double-blind, randomized, placebo-controlled Phase II study conducted in North America (U.S. and Canada) and Europe (Romania and Ukraine) in patients with mild to moderate ulcerative colitis. Treatment consisted of one of 2 doses of HMPL-004 (1200 mg daily or 1800 mg daily, administered in 3 divided doses) or matching placebo. Assessment of treatment effect is based on the Mayo score. Subjects eligible for the study will include those ≥18 years of age with mild to moderate ulcerative colitis, having a Mayo score of 4 to 10, with activity confirmed by endoscopy within 2 weeks prior to study entry, and having a Mayo endoscopy score ≥1. Subjects who are using concomitant mesalamine could enter the study. The randomization will be stratified by mesalamine use or non-use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have active confirmed mild to moderate ulcerative colitis\n\nExclusion Criteria:\n\n* Diagnosed with Crohn's Disease or"}, 'identificationModule': {'nctId': 'NCT00659802', 'briefTitle': 'Phase II Study of HMPL-004 in Patients With Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hutchmed'}, 'officialTitle': 'A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis With or Without Mesalamine', 'orgStudyIdInfo': {'id': 'HMPL-004-US-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Matching dose of placebo will be given orally in capsules three times per day for 56 days.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'HMPL-004 low dose', 'description': 'A total of 1200 mg of HMPL-004 per day in three divided doses will be given orally in capsules, 200 mg each, for 56 days.', 'interventionNames': ['Drug: HMPL-004 low dose']}, {'type': 'EXPERIMENTAL', 'label': 'HMPL-004 high dose', 'description': 'A total of 1800 mg of HMPL-004 per day in three divided doses will be given orally in capsules, 200 mg each, for 56 days.', 'interventionNames': ['Drug: HMPL-004 high dose']}], 'interventions': [{'name': 'HMPL-004 low dose', 'type': 'DRUG', 'otherNames': ['Chuan xinlian'], 'description': 'HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day).', 'armGroupLabels': ['HMPL-004 low dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching dose of Placebo', 'armGroupLabels': ['placebo']}, {'name': 'HMPL-004 high dose', 'type': 'DRUG', 'otherNames': ['Chuan xinlian'], 'description': 'HMPL-004, 600 mg (3 x 200 mg) t.i.d. (total of 1800 mg/day).', 'armGroupLabels': ['HMPL-004 high dose']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hutchison Medipharma Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}