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Trial record 159 of 372 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

Study on an Optimal Antiviral Treatment in HBeAg Positive Chronic Hepatitis B Patients

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by Xinxin Zhang, Ruijin Hospital
Sponsor:
Information provided by (Responsible Party):
Xinxin Zhang, Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT03013556
First received: December 16, 2016
Last updated: January 16, 2017
Last verified: January 2017
  Purpose
The current study is a prospective, randomized, open, multi-center investigation. The aim of the study is to investigate whether the HBeAg seroconversion rate can be improved if applying combination therapy in HBeAg positive CHB patients who has achieved HBVDNA<105copies/ml,HBsAg≤5000IU/ml, ALT≥ 2ULN or Liver histology G2S2.

Condition Intervention Phase
Chronic Hepatitis Drug: Group A, TDF Drug: Group B:TDF then TDF and Peginterferon alfa-2a Drug: Group C:TDF and Peginterferon alfa-2a then TDF Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Multicenter, Open-label Study of Optimal Antiviral Treatment in HBeAg Positive Chronic Hepatitis B Patients

Resource links provided by NLM:


Further study details as provided by Xinxin Zhang, Ruijin Hospital:

Primary Outcome Measures:
  • Number of subjects who achieve HBeAg seroconversion [ Time Frame: at 96 week ]
    The number of subjects with HBeAg seroconversion at week 96 will be measured


Secondary Outcome Measures:
  • Number of participants who achieve HBeAg seroconversion [ Time Frame: at 48 week;at 72 week ]
    The number of subjects with HBeAg seroconversion at week 48 and 72 will be measured

  • The percentage decrease of HBsAg level at group A,B,C [ Time Frame: at 48 week;at 72 week;at 96 week ]
    The level of HBsAg in group A,B,C at week 48 ,72 and 96 will be measured,changing from baseline

  • Number of participants who achieve HBeAg loss [ Time Frame: at 48 week;at 72 week;at 96 week ]
    The number of subjects with HBeAg loss at week48.72 and 96 will be measured

  • The number of subjects who achieve HBVDNA undetectable [ Time Frame: at 24 week;48 week;at 72 week;at 96 week ]
    The number of subjects with HBVDNA undetectable at week 24,48,72 and 96 will be measured

  • The factor such as HBsAg level related to responsible rate [ Time Frame: at week 48,72,96 ]
    The HBsAg level at week 48,72,96 will be measured, to assess whether the quantitative HBsAg level related to the responsible rate

  • The number of subjects who achieve ALT back to normal [ Time Frame: at 48 week;at 72 week;at 96 week ]
    The number of subjects with normal ALT at week 48,72 and 96 will be measured


Estimated Enrollment: 180
Study Start Date: November 2016
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A,TDF
The subjects in group A will be treated by TDF for 96 weeks
Drug: Group A, TDF
TDF for 96 weeks
Other Name: tenofovir
Experimental: Group B,TDF+PEG
The subjects in group B will be treated by TDF in the first 48 weeks, then will be treated by the combination of TDF and Peginterferon alfa-2a for another 48 weeks
Drug: Group B:TDF then TDF and Peginterferon alfa-2a
Subjects will be treated by TDF in the first 48 weeks, then will be treated by the combination of TDF and Peginterferon alfa-2a for another 48 weeks
Other Name: tenofovir,pegasys
Experimental: Group C,TDF+PEG
The subjects in group C will be treated by the combination of TDF and Peginterferon alfa-2a for the first 48 weeks, then will be treated by TDF for another 48 weeks
Drug: Group C:TDF and Peginterferon alfa-2a then TDF
Subjects will be treated by the combination of TDF and Peginterferon alfa-2a for the first 48 weeks, then will be treated by TDF for another 48 weeks.
Other Name: tenofovir,pegasys

Detailed Description:
The HBeAg positive chronic hepatitis B(CHB) subjects who has achieved HBV DNA<10*5copies/ml,HBsAg≤5000IU/ml, ALT≥ 2ULN or Liver histology G2S2 will be randomized to three groups. The subjects who go into group A will be treated by tenofovir disoproxil fumarate (TDF) for 96 weeks; The subjects who go into group B will be treated by TDF in the first 48 weeks, then will be treated by the combination of TDF and Peginterferon alfa-2a for another 48 weeks; The subjects who go into group C will be treated by the combination of TDF and Peginterferon alfa-2a for the first 48 weeks, then will be treated by TDF for another 48 weeks.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients with age ≥18 and ≤65 years;
  2. There should be evidences that HBsAg and HBeAg have been positive for more than 6 months with HBsAb and HBeAb negative;HBsAg≤50000IU/ml, ALT≥ 2ULN,Liver histology above G2S2 and HBV DNA≥10*5 copies/mL;
  3. Women without ongoing pregnancy or breast feeding and both women and men willing to take an effective contraceptive measure during the treatment;
  4. Agree to participate in the study and sign the patient informed consent form.

Exclusion Criteria:

  1. Treated by immunosuppressant,immunomodulator,Systemic cytotoxic drug,herbs or HBIg within 6 months prior to the first dose of treatment;
  2. ALT≥10 X ULN or total bilirubin ≥2 X ULN;
  3. Allergic history to interferon;
  4. Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human immunodeficiency virus (HIV);
  5. Child-Pugh scores >7;
  6. History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures, thalassemia);
  7. Pregnant or breast-feeding Women;
  8. Consuming alcohol in excess of 20g/day for women and 30g/day for men within 6 months prior to enrollment or drug taking history;
  9. ANC(absolute neutrophil count)<1.5x 10^9/L or PLT(platelet count)<90x 10^9/L
  10. Creatinine over upper limit of normal;
  11. History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as major depression or psychosis that treated with antidepressant medication or a major tranquilizer at therapeutic doses respectively at any time prior to 3 months or any history of the following: a suicidal attempt hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease;
  12. History of immunologically mediated disease, (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis etc.);
  13. History of esophageal varices bleeding or other evidence of esophageal varices bleeding or other symptoms consistent with decompensated liver disease;
  14. History of severe cardiac disease (e.g., New York Heart Association Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases);
  15. Hemodialysis patients or patients with renal insufficiency;
  16. History of a severe seizure disorder or current anticonvulsant use;
  17. Major organ transplantation or other evidence of severe illness, malignancy, or any other conditions, which would make the patient, in the opinion of the investigator, unsuitable for the study;
  18. History of thyroid disease poorly controlled on prescribed medications;
  19. Evidence of severe retinopathy or clinically relevant ophthalmologic disorder;
  20. History of other severe disease or evidence of other severe disease or any other illness or conditions that the investigator believe that patients are not suitable to join in the study;
  21. Patients included in another trial or having been given investigational drugs within 12 weeks prior to screening;
  22. AFP(alpha feto protein)>50ng/ml and/or evidence of hepatocellular carcinoma;
  23. Other disease should exclusive considered by the investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03013556

Contacts
Contact: Xinxin Zhang zhangx@shsmu.edu.cn

Locations
China
Xixi Hospital of Hangzhou Recruiting
Hangzhou, China
Contact: Xiaoqing Fu         
Changhai Hospital Recruiting
Shanghai, China
Contact: Mobin Wan       mobinwan@aliyun.com   
Hua shan Hospital,Fudan University Recruiting
Shanghai, China
Contact: Jiming Zhang       jmzhang@vip.126.com   
Infectious diesease hospital of Huangpu district in Shanghai Recruiting
Shanghai, China
Contact: Hailin Liang         
No.9 hospital of shanghai Recruiting
Shanghai, China
Contact: Jie Xu       dr.xu@aliyun.com   
Shanghai public health clinical center Recruiting
Shanghai, China
Contact: Liang Chen       chenliang@shaphc.org   
Shuguang Hospital of Shanghai T.C.M Recruiting
Shanghai, China
Contact: yueqiu Gao       gaoyueqiu@hotmail.com   
Tongren hospital Shanghai Jiaotong University School of medicine Recruiting
Shanghai, China
Contact: Qin Zhang         
Sponsors and Collaborators
Ruijin Hospital
Investigators
Principal Investigator: Xinxin Zhang Ruijin Hospital
  More Information

Publications:
Responsible Party: Xinxin Zhang, vice president of Ruijin hospital(North collegue), Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03013556     History of Changes
Other Study ID Numbers: SHDC12016101
Study First Received: December 16, 2016
Last Updated: January 16, 2017

Keywords provided by Xinxin Zhang, Ruijin Hospital:
HBeAg positive

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Tenofovir
Antiviral Agents
Peginterferon alfa-2a
Interferon-alpha
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 19, 2017