Ignite Creation Date:
2025-12-24 @ 12:53 PM
Ignite Modification Date:
2025-12-29 @ 6:01 AM
Study NCT ID:
NCT00917761
Status:
UNKNOWN
Last Update Posted:
2012-12-20
First Post:
2009-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Entecavir and Pegasys Sequential Therapy Versus Pegasys for HBeAg Negative 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'}, {'id': 'C100416', 'term': 'peginterferon alfa-2a'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-12-19', 'studyFirstSubmitDate': '2009-06-08', 'studyFirstSubmitQcDate': '2009-06-09', 'lastUpdatePostDateStruct': {'date': '2012-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HBV virologic response (HBV DNA < 2,000 IU/mL) 6 months after the cessation of treatment', 'timeFrame': '2.5 years'}], 'secondaryOutcomes': [{'measure': 'ALT normalization rate (ALT < 40 IU/L) 6 months after the cessation of treatment', 'timeFrame': '2.5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatitis B, chronic', 'Peginterferon alfa-2a', 'Entecavir'], 'conditions': ['Hepatitis B, Chronic']}, 'descriptionModule': {'briefSummary': 'Currently, peginterferon alfa-2a or oral nucleos(t)ides are approved for the treatment with HBeAg negative CHB, with the overall ALT normalization and HBV viral suppression far from satisfactory. Therefore, efforts on the various combinations with the currently available drugs are needed to improve the overall response rates. The simultaneous combination therapy with oral nucleoside and peginterferon alfa-2a from large-scaled randomized trials did not show a superior response rate over peginterferon alfa-2a monotherapy. Recently, sequential monotherapy with lamivudine for the first 4 weeks, followed by weekly peginterferon alfa-2a has shown favorable HBeAg seroconversion rate over peginterferon alfa-2a monotherapy, based on the assumption that early viral suppression by lamivudine can restore the immune function to facilitate the later immunomodulatory response by peginterferon alfa-2a. Furthermore, prior studies using 24 months of standard interferon alfa showed better ALT normalization and HBV suppression rates to 12 months of therapy. With the recent introduction of entecavir, the more potent oral nucleoside with few drug resistance, sequential monotherapy with entecavir can potently suppress HBV DNA with 4 weeks of treatment, which may facilitate the response of peginterferon alfa-2a to achieve HBV viral suppression. Therefore, we aimed to conduct a placebo controlled randomized control trial to evaluate if adding entecavir early in the course of therapy or extending the treatment duration of peginterferon alfa-2a can improve the treatment response.', 'detailedDescription': 'Chronic hepatitis B (CHB) is prevalent in the world, with estimated chronic carriers of 350 millions worldwide. Currently, peginterferon alfa-2a or oral nucleos(t)ides are approved for the treatment with HBeAg negative CHB, with the overall ALT normalization and HBV viral suppression far from satisfactory. Therefore, efforts on the various combinations with the currently available drugs are needed to improve the overall response rates. The simultaneous combination therapy with oral nucleoside and peginterferon alfa-2a from large-scaled randomized trials did not show a superior response rate over peginterferon alfa-2a monotherapy. Recently, sequential monotherapy with lamivudine for the first 4 weeks, followed by weekly peginterferon alfa-2a has shown favorable HBeAg seroconversion rate over peginterferon alfa-2a monotherapy, based on the assumption that early viral suppression by lamivudine can restore the immune function to facilitate the later immunomodulatory response by peginterferon alfa-2a. Furthermore, prior studies using 24 months of standard interferon alfa showed better ALT normalization and HBV suppression rates to 12 months of therapy. With the recent introduction of entecavir, the more potent oral nucleoside with few drug resistance, sequential monotherapy with entecavir can potently suppress HBV DNA with 4 weeks of treatment, which may facilitate the response of peginterferon alfa-2a to achieve HBV viral suppression. Therefore, we aimed to conduct a placebo controlled randomized control trial to evaluate if adding entecavir early in the course of therapy or extending the treatment duration of peginterferon alfa-2a can improve the treatment response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic hepatitis B (presence of HBsAg \\> 6 months) with anti-HBe persistence and abscence of HBeAg for more than 3 months\n* Age older than 18 years\n* HBV DNA \\> 2,000 IU/mL for more than 2 occasions\n* Serum ALT levels between 2 to 10 folds the upper limit of normal (ULN)\n* A liver biopsy compatible with chronic hepatitis B\n\nExclusion Criteria:\n\n* Anemia (hemoglobin \\< 13 gram per deciliter for men and \\< 12 gram per deciliter for women)\n* Neutropenia (neutrophil count \\<1,500 per cubic milliliter)\n* Thrombocytopenia (platelet \\<90,000 per cubic milliliter)\n* Co-infection with hepatitis B virus (HBV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV)\n* Chronic alcohol abuse (daily consumption \\> 20 gram per day)\n* Decompensated liver disease (Child-Pugh class B or C)\n* Serum creatinine level more than 1.5 times the upper limit of normal\n* Autoimmune liver disease\n* Neoplastic disease\n* An organ transplant\n* Immunosuppressive therapy\n* Poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus\n* Evidence of drug abuse\n* Unwilling to have contraception\n* Known allergic reaction to entecavir or peginterferon alfa-2a\n* Unwilling to sign inform consent'}, 'identificationModule': {'nctId': 'NCT00917761', 'briefTitle': 'Entecavir and Pegasys Sequential Therapy Versus Pegasys for HBeAg Negative Chronic Hepatitis B', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Entecavir and Peginterferon Alfa-2a Sequential Therapy Versus Peginterferon Alfa-2a Monotherapy for HBeAg Negative Chronic Hepatitis B', 'orgStudyIdInfo': {'id': '950924'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Entecavir and peginterferon (52 weeks)', 'description': 'Entecavir 0.5 mg/day po at week 1-4 Peginterferon alfa-2a 180 ug/week sc at week 5-52', 'interventionNames': ['Drug: Entecavir and peginterferon (Pegasys) (52 weeks)']}, {'type': 'EXPERIMENTAL', 'label': 'Peginterferon (96 weeks)', 'description': 'Peginterferon alfa-2a 180 ug/week sc at week 1-96', 'interventionNames': ['Drug: Peginterferon (Pegasys) (96 weeks)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Peginterferon (48 weeks)', 'description': 'Peginterferon alfa-2a 180 ug/week sc at week 1-48', 'interventionNames': ['Drug: Peginterferon (Pegasys) (48 weeks)']}], 'interventions': [{'name': 'Entecavir and peginterferon (Pegasys) (52 weeks)', 'type': 'DRUG', 'otherNames': ['Entecavir (Baraclude)0.5 mg/day po at week 1-4', 'Peginterferon alfa-2a (Pegasys) 180 ug/week sc at week 5-52'], 'description': 'Entecavir 0.5 mg/day po at week 1-4 Peginterferon alfa-2a 180 ug/week sc at week 5-52', 'armGroupLabels': ['Entecavir and peginterferon (52 weeks)']}, {'name': 'Peginterferon (Pegasys) (96 weeks)', 'type': 'DRUG', 'otherNames': ['Peginterferon alfa-2a (Pegasys) 180 ug/week sc at week 1-96'], 'description': 'Peginterferon alfa-2a 180 ug/week sc at week 1-96', 'armGroupLabels': ['Peginterferon (96 weeks)']}, {'name': 'Peginterferon (Pegasys) (48 weeks)', 'type': 'DRUG', 'otherNames': ['Peginterferon alfa-2a (Pegasys) 180 ug/week sc at week 1-48'], 'description': 'Peginterferon alfa-2a 180 ug/week sc at week 1-48', 'armGroupLabels': ['Peginterferon (48 weeks)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Douliu', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Shih-Jer Hsu, MD', 'role': 'CONTACT'}, {'name': 'Shih-Jer Hsu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ping-Huei Tseng, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chieh-Chang Chen, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ming-Lun Han, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jou-Wei Lin, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jun-Herng Chen, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'National Taiwan University Hosptial, Yun-Lin Branch', 'geoPoint': {'lat': 23.70944, 'lon': 120.54333}}, {'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Sheng-Shun Yang, MD, PhD', 'role': 'CONTACT'}, {'name': 'Sheng-Shun Yang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '10002', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chen-Hua Liu, MD', 'role': 'CONTACT'}, {'name': 'Chen-Hua Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jia-Horng Kao, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Chun-Jen Liu, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ming-Yang Lai, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pei-Jer Chen, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ding-Shinn Chen, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ching-Sheng Hsu, MD', 'role': 'CONTACT'}, {'name': 'Ching-Sheng Hsu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Chia-Chi Wang, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tai-Chung Tseng, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Buddhist Tzu Chi General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Cheng-Chao Liang, MD', 'role': 'CONTACT'}, {'name': 'Cheng-Chao Liang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Far Eastern Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chih-Lin Lin, MD', 'role': 'CONTACT'}, {'name': 'Chih-Lin Lin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ping-Yeh Wu, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ren-Ai Branch, Taipei Municipal Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Chen-Hua Liu, MD', 'role': 'CONTACT', 'email': 'jacque_liu@mail2000.com.tw', 'phone': '886-2-23123456', 'phoneExt': '63572'}, {'name': 'Jia-Horng Kao, MD, PhD', 'role': 'CONTACT', 'email': 'kaojh@ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '67307'}], 'overallOfficials': [{'name': 'Chen-Hua Liu, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Taiwan University Hospital'}, {'name': 'Jia-Horng Kao, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}, {'name': 'Shih-Jer Hsu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hosptial, Yun-Lin Branch'}, {'name': 'Chih-Lin Lin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ren-Ai Branch, Taipei City Hospital'}, {'name': 'Cheng-Chao Liang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Far Eastern Memorial Hospital'}, {'name': 'Ching-Sheng Hsu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Buddhist Tzu Chi General Hospital'}, {'name': 'Sheng-Shun Yang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taichung Veterans General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Science and Technology Council, Taiwan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}