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Combined Therapy With Peginterferon Alfa-2a With NA in NA-treated HBeAg Positive Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02474316
Recruitment Status : Unknown
Verified June 2015 by Qing XIe, Ruijin Hospital.
Recruitment status was:  Recruiting
First Posted : June 17, 2015
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
Qing XIe, Ruijin Hospital

Brief Summary:

This is a prospective, randomized, multicenter, open-label study. After more than 24 weeks NA treatment, HBeAg positive CHB patients who achieved HBV DNA<1000copies/ml but HBeAb negative, will be randomized (1:1) into 2 study arms as follows:

Arm A: Peginterferon alfa-2a 180μg /wk plus NA 1 piece qd for 48 weeks Arm B: Entecavir 0.5mg qd for 48 weeks


Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: Peginterferon alfa-2a Drug: nucleos(t)ide analgoue Phase 4

Detailed Description:

This is a prospective, randomized, multicenter, open-label study. After more than 24 weeks NA treatment, HBeAg positive CHB patients who achieved HBV DNA<1000copies/ml but HBeAb negative, will be randomized (1:1) into 2 study arms as follows:

Arm A: Peginterferon alfa-2a 180μg /wk plus NA 1piece qd for 48 weeks Arm B:NA 1 piece qd for 48 weeks

The primary endpoint: HBeAg seroconversion at week 48

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 366 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Multicenter, Open-label Study Evaluating HBeAg Seroconversion in HBeAg Positive CHB Patients on Treatment With NA Switched to Combined Therapy With Peginterferon Alfa-2a and NA for 48 Weeks
Study Start Date : August 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PegINF plus nucleos(i)de analgoue
Peginterferon alfa-2a 180μg /wk plus nucleos(t)ide analgoue (NA) 1 piece qd for 48 weeks
Drug: Peginterferon alfa-2a
Peginterferon alfa-2a 180ug/wk s.c for 48 weeks
Other Name: Pegasys

Drug: nucleos(t)ide analgoue
nucleos(t)ide analgoue (NA) 1 piece p.o for 48 weeks

Active Comparator: nucleos(t)ide analgoue
nucleos(t)ide analgoue (NA) 1 piece qd for 48 weeks
Drug: nucleos(t)ide analgoue
nucleos(t)ide analgoue (NA) 1 piece p.o for 48 weeks




Primary Outcome Measures :
  1. Number of participants who achieve HBeAg seroconversion [ Time Frame: at week 48 ]
    To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the HBeAg seroconversion in HBeAg positive CHB patients on treatment with Entecavir and with HBV DNA <1000copies/ml which will be measured by the number of participants who achieve HBeAg seroconversion


Secondary Outcome Measures :
  1. Number of participants who achieve HBeAg loss [ Time Frame: at week 48 ]
    To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve HBeAg seroconversion which will be measured by number of participants who achieve HBeAg loss

  2. Number of participants who achieve HBsAg loss [ Time Frame: at week 48 ]
    To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve HBsAg loss which will be measured by number of participants who achieve HBsAg loss

  3. Number of participants who achieve HBsAg seroconversion [ Time Frame: at week 48 ]
    To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve HBsAg seroconversion which will be measured by number of participants who achieve HBsAg seroconversion

  4. HBsAg decline from baseline [ Time Frame: at week 48 ]
    To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve HBsAg decline from baseline

  5. Percentage of participants who achieve HBsAg <1000IU/mL [ Time Frame: at week 48 ]
    To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the percentage of participants who achieve HBsAg<1000IU/mL

  6. Percentage of of participants who achieve HBsAg <100IU/mL [ Time Frame: at week 48 ]
    To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the percentage of of participants who achieve HBsAg<100IU/mL

  7. Number of participants who achieve combined response I (defined as HBeAg seroconversion and HBV DNA<100000copies/mL) [ Time Frame: at week 48 ]
    To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the combined response I which will be measured by number of participants who achieve combined response I

  8. Number of participants who achieve combined response II (defined as HBeAg seroconversion and HBV DNA<1000copies/mL) [ Time Frame: at week 48 ]
    To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the combined response II which will be measured by number of participants who achieve combined response II

  9. Number of participants who achieve dural response I (defined as HBeAg seroconversion and HBsAg<1000IU/mL) [ Time Frame: at week 48 ]
    To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the dural response I which will be measured by number of participants who achieve dural response I

  10. Number of participants who achieve dural response II (defined as HBeAg seroconversion and HBsAg<100IU/mL) [ Time Frame: at week 48 ]
    To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the dural response II which will be measured by number of participants who achieve dural response II

  11. Number of Participants with AE [ Time Frame: at week 48 ]
    Number of participants with adverse events as a measure of safety and tolerability

  12. Number of Participants with SAE [ Time Frame: at week 48 ]
    Number of participants with SAEs as a measure of safety and tolerability



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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 before treated with Entecavir;
  3. Treated with NA for more than 24 weeks and achieve HBV DNA<1000copies/ml with HBeAb negative;
  4. Women without ongoing pregnancy or breast feeding and willing to take an effective contraceptive measure during the treatment
  5. Agree to participate in the study and sign the patient informed consent.

Exclusion Criteria:

  1. Co-infection with active hepatitisA, hepatitisC, hepatitisD and/or human immunodeficiency virus (HIV)
  2. AFP>50ng/ml and/or evidence of hepatocellular carcinoma
  3. Evidence of decompensated liver disease (Child-Pugh scores >5). Child-Pugh >5 means that, if one of the following 6 conditions is met, the patient has to be excluded:

    1. Serum albumin <35 g/L;
    2. Prothrombine time prolonged≥ 4 seconds or PTA < 60%;
    3. Serum bilirubin > 34 µmol/L;
    4. History of encephalopathy;
    5. Ascites
  4. 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)
  5. Pregnant or breast-feeding Women
  6. ANC<1.5x 10^9/L or PLT<90x 10^9/L
  7. Consuming alcohol in excess of 20g/day for women and 30g/day for men within 6 months prior to enrollment
  8. 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
  9. History of immunologically mediated disease, (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis etc.)
  10. History of esophageal varices bleeding or other evidence of esophageal varices bleeding or other symptoms consistent with decompensated liver disease
  11. History of chronic pulmonary disease associated with functional limitation
  12. History of severe cardiac disease (e.g., NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases)
  13. Hemodialysis patients or patients with renal insufficiency
  14. History of a severe seizure disorder or current anticonvulsant use
  15. 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
  16. History of thyroid disease poorly controlled on prescribed medications
  17. Evidence of severe retinopathy or clinically relevant ophthalmologic disorder
  18. 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
  19. Immunomodulatory treatment (including interferon) or LDT within 1 year prior to the first dose of treatment
  20. Patients included in another trial or having been given investigational drugs within 12 weeks prior to screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02474316


Contacts
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Contact: Qing Xie 86-13651804273 xieqingrjh2015@gmail.com

Locations
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China
The Third People's Hospital of Guilin Recruiting
Guilin, China
Contact: Shuquan Chen, doctor         
Ruijin Hospital Recruiting
Shanghai, China
Contact: Qing Xie, doctor         
Contact: Wei Cai, doctor         
Shanghai Public Health Clinical Center Recruiting
Shanghai, China
Contact: Liang Chen, doctor         
Sponsors and Collaborators
Ruijin Hospital
Investigators
Layout table for investigator information
Study Chair: Qing Xie Ruijin Hospital

Publications of Results:

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Responsible Party: Qing XIe, Director of infectious disease, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT02474316    
Other Study ID Numbers: HOPE
First Posted: June 17, 2015    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis, Chronic
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs