Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT07203118
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-02
First Post:
2025-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase II/III of Hepenofovir Fumarate Tablets (HTS) for Chronic Hepatitis B
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}], 'ancestors': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012462', 'term': 'Saline Solution, Hypertonic'}], 'ancestors': [{'id': 'D006982', 'term': 'Hypertonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1444}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2030-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2025-09-15', 'studyFirstSubmitQcDate': '2025-09-23', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events of the Optimal Dosing Regimen as assessed by CTCAE v5.0', 'timeFrame': 'through study completion, an average of 1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis B']}, 'descriptionModule': {'briefSummary': 'UsingTAF as the control, the nvestigators aim to further explore the efficacy and safety of different dosages of HTS in the treatment of patients with chronic hepatitis B; ultimately, the nvestigators determine the optimal recommended dosage of HTS to provide a basis for Phase III confirmatory clinical research.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1）Age between 18 to 65 years old (inclusive), regardless of gender. 2) Meets diagnostic criteria for chronic hepatitis B (documented HBsAg positivity or HBV DNA positivity for more than 6 months, or confirmed by liver biopsy histopathology).\n\n3)No prior treatment with any nucleos(t)ide analogue oral antiviral therapy; or, previous treatment with any nucleos(t)ide analogue must have ended at least 6 months prior to baseline.\n\n4\\) Any interferon therapy (both pegylated and non-pegylated) must be completed at least 1 year prior to baseline visit.\n\n5\\) Willing to use effective non-pharmacological contraception during the trial period.\n\nExclusion Criteria:\n\n1. Hypersensitive to the study drug, its metabolites or any excipient in its formula;\n2. With previous or present clinical hepatic decompensation (e.g., ascites, hepatic encephalopathy or varicose vein haemorrhage)\n3. Complicated with liver diseases, including chronic alcoholic hepatitis, drug-induced hepatitis, etc.\n4. Complicated with HCV, HIV or HDV infections\n5. Documented resistance to the antiviral drug (Tenofovir).\n6. Any cardiovascular, hematologic,pulmonary or nervous diseases deemed serious by the investigator'}, 'identificationModule': {'nctId': 'NCT07203118', 'briefTitle': 'A Phase II/III of Hepenofovir Fumarate Tablets (HTS) for Chronic Hepatitis B', 'organization': {'class': 'OTHER', 'fullName': "Xi'an Xintong Pharmaceutical Research Co.,Ltd."}, 'officialTitle': 'A Phase II/III Seamless Design Clinical Trial of Hepenofovir Fumarate Tablets (HTS) for Chronic Hepatitis B', 'orgStudyIdInfo': {'id': 'XAXT-2024-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HTS 20mg', 'interventionNames': ['Drug: HTS 20mg']}, {'type': 'EXPERIMENTAL', 'label': 'HTS 30mg', 'interventionNames': ['Drug: HTS 30mg']}, {'type': 'EXPERIMENTAL', 'label': 'HTS 40mg', 'interventionNames': ['Drug: HTS 40mg']}, {'type': 'EXPERIMENTAL', 'label': 'TAF 25mg', 'interventionNames': ['Drug: TAF 25mg']}], 'interventions': [{'name': 'HTS 20mg', 'type': 'DRUG', 'description': 'Once daily, administered concomitantly with one TAF placebo tablet per dose, taken once daily with or within 30 minutes after a meal.', 'armGroupLabels': ['HTS 20mg']}, {'name': 'HTS 30mg', 'type': 'DRUG', 'description': 'Once daily, administered concomitantly with one TAF placebo tablet per dose, taken once daily with or within 30 minutes after a meal.', 'armGroupLabels': ['HTS 30mg']}, {'name': 'HTS 40mg', 'type': 'DRUG', 'description': 'Once daily, administered concomitantly with one TAF placebo tablet per dose, taken once daily with or within 30 minutes after a meal.', 'armGroupLabels': ['HTS 40mg']}, {'name': 'TAF 25mg', 'type': 'DRUG', 'description': 'Once daily, administered concomitantly with one HTS placebo tablet per dose, taken once daily with or within 30 minutes after a meal.', 'armGroupLabels': ['TAF 25mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jilin', 'state': 'changchun', 'country': 'China', 'facility': 'The First Hospital of Jilin University', 'geoPoint': {'lat': 43.84652, 'lon': 126.5608}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Xi'an Xintong Pharmaceutical Research Co.,Ltd.", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}