Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2026-01-28 @ 4:04 PM
Study NCT ID:
NCT04180150
Status:
UNKNOWN
Last Update Posted:
2019-12-16
First Post:
2019-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of TQ-A3334 Combined With Entecavir in the Treatment of 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': 'C413685', 'term': 'entecavir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-12', 'studyFirstSubmitDate': '2019-11-26', 'studyFirstSubmitQcDate': '2019-11-26', 'lastUpdatePostDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'Hour 0, 5, 10, 20, 30 minutes, 1, 2 , 3 , 6 , 12, 24, 72 , 168 hours post-dose at week 1 and week 12; Hour 0 of week 4, week 7, week 9, week 11.', 'description': 'Cmax is the maximum plasma concentration of TQ-A3334 or metabolite(s).'}, {'measure': 'Tmax', 'timeFrame': 'Hour 0, 5, 10, 20, 30 minutes, 1, 2 , 3 , 6 , 12, 24, 72 , 168 hours post-dose at week 1 and week 12; Hour 0 of week 4, week 7, week 9, week 11.', 'description': 'To characterize the pharmacokinetics of TQ-A3334 by assessment of time to reach maximum plasma concentration.'}, {'measure': 'AUC0-t', 'timeFrame': 'Hour 0, 5, 10, 20, 30 minutes, 1, 2 , 3 , 6 , 12, 24, 72 , 168 hours post-dose at week 1 and week 12; Hour 0 of week 4, week 7, week 9, week 11.', 'description': 'To characterize the pharmacokinetics of TQB3804 by assessment of area under the plasma concentration time curve from zero to infinity.'}, {'measure': 'Cytokine', 'timeFrame': 'Hour 0, 1.5 , 12 , 24 , 72 hours post-dose at week 1 and week 12; Hour 0 at week 7.', 'description': 'Including IFN-α, IFN-γ, TNF-α, IL-6, IL-2, MCP-1 and so on.'}], 'secondaryOutcomes': [{'measure': 'HBV biomarker', 'timeFrame': 'Day 1 pre-dose, day 84, day 168, day 336 post-dose.', 'description': 'Including HBsAg, HBsAb, HBeAb, anti-HBc, HBV-DNA, HBV RNA and HBcrAg.'}, {'measure': 'Lymphocyte function', 'timeFrame': 'Hour 0 pre-dose, day 56, day 84, day 168 at post-dose.', 'description': 'Analysis of immune cell response to hepatitis B antigen after treatment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis B']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blinded, placebo-controlled, phase IIa study to evaluate safety and efficacy of TQ-A3334 combined with entecavir in the untreated or HBV DNA negative subjects with Chronic Hepatitis B.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. 18 and 65 years old ; 2. HBsAg positive at least for 6 months ; 3. HBeAg positive chronic hepatitis B, HBV DNA \\> 10\\^5 copies/ml; 4. Fibroscan ≤ 12.4 Kpa，2×ULN ≤ ALT ≤ ULN; 5. New diagnosed chronic hepatitis B subjects;\n\nExclusion Criteria:\n\n* 1.Combined with other virus infection ; 2.Has cirrhosis or hepatocellular carcinoma; 3.Has autoimmune diseases; 4.Has thyroid disease; 5.Has eye diseases; 6.Has clinically significant abnormalities/diseases ≥ grade 2; 7.Has history of chronic kidney disease, renal insufficiency, renal anemia; 8.Peripheral blood index is low; 9.Has a history of allergy to experimental drugs or their excipients; 10.Has participated in other clinical trials within 3 months; 11.Breastfeeding or pregnant women.; Men unwilling to use adequate contraceptive measures during the study; 12.According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.; 13.Has history of drug abuse in the past five years;'}, 'identificationModule': {'nctId': 'NCT04180150', 'briefTitle': 'A Study of TQ-A3334 Combined With Entecavir in the Treatment of Chronic Hepatitis B', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'A Randomized, Double-blinded, Placebo-controlled, Phase IIa Study of TQ-A3334 Combined With Entecavir in the Treatment of Untreated or HBV DNA Negative Subjects With Chronic Hepatitis B', 'orgStudyIdInfo': {'id': 'TQ-A3334-II-01a'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TQ-A3334 combined with entecavir', 'description': 'Subjects receive TQ-A3334 (1.2 mg QW) and entecavir (0.5 mg qd) in 24 weeks', 'interventionNames': ['Drug: TQ-A3334', 'Drug: Entecavir Tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo combined with entecavir', 'description': 'Subjects receive placebo (0 mg QW) and entecavir (0.5 mg qd) in 24 weeks', 'interventionNames': ['Drug: Placebo', 'Drug: Entecavir Tablet']}], 'interventions': [{'name': 'TQ-A3334', 'type': 'DRUG', 'description': 'TQ-A3334 is a kind of TLR7 receptor agonist.', 'armGroupLabels': ['TQ-A3334 combined with entecavir']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo is a treatment which is designed to have no therapeutic value.', 'armGroupLabels': ['Placebo combined with entecavir']}, {'name': 'Entecavir Tablet', 'type': 'DRUG', 'description': 'Entecavir (ETV) tablet is an antiviral medication used in the treatment of hepatitis B virus (HBV) infection.', 'armGroupLabels': ['Placebo combined with entecavir', 'TQ-A3334 combined with entecavir']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Ren, M.D.', 'role': 'CONTACT', 'email': 'renhong0531@vip.sina.com', 'phone': '023-63693213'}, {'name': 'Hong Ren', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The second affiliated hospital of chongqing medical university', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Changchun', 'state': 'Jinlin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junqi Niu, M.D.', 'role': 'CONTACT', 'email': 'junqiniu@aliyun.com', 'phone': '0431-88782168'}, {'name': 'Junqi Niu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The first hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}], 'centralContacts': [{'name': 'Junqi Niu, M.D.', 'role': 'CONTACT', 'email': 'junqiniu@aliyun.com', 'phone': '0431-88782168'}, {'name': 'Hong Ren, M.D.', 'role': 'CONTACT', 'email': 'renhong0531@vip.sina.com', 'phone': '023-63693213'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}