Efficacy and Safety of Entecavir Maleate Tablets in Chinese Patients With Hepatitis B

NCT01926288 | Completed Phase 4 DMC

• 1 other identifier: CTTQ805-4
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of Entecavir maleate tablets in Chinese patients with hepatitis B

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Compared with baseline, decline of serum HBV-DNA in the value

  5 years

Study Arms (2)

HBeAg positive group

OTHER

Entecavir maleate tablets (1) + blank Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks . Blank maleate entecavir tablets (1) + Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks .

Drug: Entecavir maleate tablets; Drug: blank Baraclude tablets; Drug: Blank maleate entecavir tablets; Drug: Baraclude tablets

HBeAg-negative group

OTHER

Entecavir maleate tablets (1) + blank Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks . Blank maleate entecavir tablets (1) + Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks .

Drug: Entecavir maleate tablets; Drug: blank Baraclude tablets; Drug: Blank maleate entecavir tablets; Drug: Baraclude tablets

Interventions

Entecavir maleate tablets DRUG

HBeAg positive group; HBeAg-negative group

blank Baraclude tablets DRUG

HBeAg positive group; HBeAg-negative group

Blank maleate entecavir tablets DRUG

HBeAg positive group; HBeAg-negative group

Baraclude tablets DRUG

HBeAg positive group; HBeAg-negative group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects diagnosed of HBeAg positive or negative chronic hepatitis B
• Aged 18 to 70 years old，male or female
• Patients with previously HBsAg-positive, HBeAg-positive for 24 weeks, HBV-DNA\> 105copies/ml. HBeAg-negative for 24 weeks or more, HBV-DNA\> 105 copies/ml.
• times the upper normal limit (1.3 × ULN) ≤ alanine aminotransferase (ALT) ≤ 10 × ULN.
• Total serum bilirubin (TBIL) ≤ 2.5 × ULN.
• Prothrombin activity (PTA) ≥ 60% or prothrombin time prolonged than normal ≤ 3 seconds).
• WBC ≥ 3.5 × 109 / L, PLT ≥ 70 × 109 / L, serum albumin (ALB)≥ 35 g / L.
• Creatinine (Cr) ≤ 1.5 × ULN.
• If patients take intermittently with interferon, nucleoside (acid) analogues, α1 thymosin before enrollment with 24 weeks, the time is no more than 12 weeks.
• Patients signed an informed consent form and compliance was good.

You may not qualify if:

• Patients were infected with other viruses as HAV, HCV, HDV, HEV, CMV, EBV, HIV etc.
• Patients with cirrhosis or liver cancer.
• Patients have participated in another therapeutic clinical trial in 3 months.
• Granulocyte count \<1.5 × 109 / L, hemoglobin (HB)\<100g / L, sera alpha-fetoprotein(AFP)\> 100μg / L, patients' B ultrasonography pointed space-occupying lesions.
• Patients with severe heart, kidney, endocrine hematopoietic system and neuropsychiatric diseases.
• Patients with metabolic or autoimmune diseases such as systemic lupus erythematosus.
• Pregnant woman, lactating women or those who wre allergic for study drug.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (9)

Department of Infectious Diseases,Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Beijing You An Hospital,Capital Medical University

Beijing, Beijing Municipality, 100054, China

Location

The First Affiliated Hospital Of The Third Mililary Medical University

Chongqing, Chongqing Municipality, 400038, China

Location

Tongji Medical College of Hust Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

The First Affiliated Hospital Of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Shanghai Jiaotong University Affiliated Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

The Second Affiliated Hospital Of Chongqing Medical University

Chongqing, Sichuan, 400010, China

Location

West China Hospital Of Sichuan University

Chongqing, Sichuan, 400010, China

Location

The First Affiliated Hospital Of Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (3)

• Xu JH, Wang S, Zhang DZ, Yu YY, Si CW, Zeng Z, Xu ZN, Li J, Mao Q, Tang H, Sheng JF, Chen XY, Ning Q, Shi GF, Xie Q, Zhang XQ, Dai J. One hundred and ninety-two weeks treatment of entecavir maleate for Chinese chronic hepatitis B predominantly genotyped B or C. World J Clin Cases. 2022 Oct 6;10(28):10085-10096. doi: 10.12998/wjcc.v10.i28.10085.

  PMID: 36246814 DERIVED

• Xu JH, Wang S, Xu ZN, Yu YY, Si CW, Zeng Z, Li J, Mao Q, Zhang DZ, Tang H, Sheng JF, Chen XY, Ning Q, Shi GF, Xie Q, Zhang XQ, Dai J. Entecavir maleate versus entecavir in Chinese chronic hepatitis B predominantly genotype B or C: Results at week 144. J Viral Hepat. 2017 Oct;24(10):877-884. doi: 10.1111/jvh.12710. Epub 2017 Aug 11.

  PMID: 28345157 DERIVED

• Li N, Xu JH, Yu M, Wang S, Si CW, Yu YY. Relationship between virological response and FIB-4 index in chronic hepatitis B patients with entecavir therapy. World J Gastroenterol. 2015 Nov 21;21(43):12421-9. doi: 10.3748/wjg.v21.i43.12421.

  PMID: 26604649 DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yu Yan yan, doctor

  Department of Infectious Diseases,Peking University First Hospital

  PRINCIPAL INVESTIGATOR

• Shi Guang feng, doctor

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

• Xie Qing, doctor

  Shanghai Jiaotong University Affiliated Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Tang Hong, doctor

  West China Hospital

  PRINCIPAL INVESTIGATOR

• Zhang Da zhi, doctor

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

• Mao Qing, doctor

  The First Affiliated Hospital Of The Third Mililary Medical University

  PRINCIPAL INVESTIGATOR

• Ning Qin, doctor

  Tongji Medical College of Hust Tongji Medical College Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

• Li Jun, doctor

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Sheng Ji fang, doctor

  Zhejiang University

  PRINCIPAL INVESTIGATOR

• Cheng Xin fang, doctor

  Beijing You An Hospital,Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2013
• First Posted: August 20, 2013
• Study Start: October 1, 2008
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: December 29, 2017

Record last verified: 2013-08

Locations

CN (9)