{ "data": { "asOf": "2026-10-30T22:23:55.696Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT03181607", "title": "Efficacy and Adverse Effects of Nucleoside Analogues (TDF/LDT) in Preventing Mother-to-child Transmission of HBV", "scientificTitle": "The 3rd Affiliated Hospital, Guangzhou Medical University", "status": "completed", "studyType": "observational", "phase": [], "conditions": [ "Chronic Hepatitis b", "Women" ], "interventions": [], "sponsor": { "name": "Xingfei Pan", "type": "OTHER" }, "locations": [ { "city": "Guanzhou", "country": "China", "facility": "The 3rd Affiliated Hospital, Guangzhou Medical University" } ], "outcomes": { "other": [], "primary": [ "The proportion of hepatitis B infections in the infants at 1 year of age" ], "secondary": [ "The proportion of birth defects in the infants at 1 month age", "Growth parameters of the infants", "HBV DNA quantification of mothers", "ALT levels of mothers", "HBeAg conversion rate of mothers" ] }, "eligibility": { "sex": "FEMALE", "criteria": "Inclusion Criteria:\n\n* Age of 20-40 years.\n* The history of HBV infection ≥6 months.\n* Positive for HBsAg.\n* For immune-tolerant patients, HBV DNA load of ≥ 10\\^6IU/ml at 24-28 weeks of gestation.\n* For patients already administrated with nucleoside analogues (NA) treatment, the therapy could be not discontinued and TDF or LDT should be used to treat these patients.\n* For patients never administrated with NA treatment, ALT ≥2 times of the upper limit of normal (ULN), HBV DNA load of ≥ 10\\^4IU/ml (positive for HBeAg) or HBV DNA load of ≥ 10\\^3IU/ml (negative for HBeAg), traditional protecting liver and reducing enzyme treatment was failed.\n* The good compliance of patients.\n\nExclusion Criteria:\n\n* Patients with antibodies against HIV, HCV, HDV, or other forms of chronic liver disease.\n* Evidence of hepatocellular carcinoma, decompensated liver disease, auto-immune hepatitis, or significant renal, cardiovascular, respiratory or neurological comorbidity.\n* Concurrent treatment with nephrotoxic drugs, glucocorticoids, cytotoxic drugs, nonsteroidal anti-inflammatory drugs, or immune modulators.\n* Ultra-sonographic evidence of fetal deformity, abnormal fetal development or placental abnormality.\n* Clinical signs of threatened miscarriage.\n* History of complication of pregnancy.\n* Presence of chronic HBV infection in the biologic father.", "maximumAge": "40 Years", "minimumAge": "20 Years", "healthyVolunteers": false }, "enrollment": { "type": "ACTUAL", "count": 153 }, "startDate": "2017-01-01", "completionDate": "2022-12-31", "lastUpdated": "2026-10-16T00:00:00.000Z", "firstPosted": "2017-06-09T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT03181607" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT03181607", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT03181607", "sourceUrl": "https://clinicaltrials.gov/study/NCT03181607", "sourceStatus": "COMPLETED", "retrievedAt": "2026-10-28T04:32:44.640Z", "payloadSha256": "650fde9e6f72b2df893cb68c034699a48518b5a1147191e408ca8b8726490bd8", "piiRedacted": true } ], "citation": { "canonicalId": "NCT03181607", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT03181607", "verifyAt": "https://clinicaltrials.gov/study/NCT03181607", "retrievedAt": "2026-10-28T04:32:44.640Z", "payloadSha256": "650fde9e6f72b2df893cb68c034699a48518b5a1147191e408ca8b8726490bd8", "text": "ClinicalTrials.gov, record NCT03181607 (https://clinicaltrials.gov/study/NCT03181607), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT03181607, registered in ClinicalTrials.gov, retrieved 2026-10-28. 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