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A Study to Evaluate Addition of Peginterferon Alfa-2a to Chronic Hepatitis B (CHB) Patients Treated With NAs

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. Identifier: NCT02894918
Recruitment Status : Unknown
Verified September 2016 by Jiashang, Henan Provincial People's Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 9, 2016
Last Update Posted : September 12, 2016
Information provided by (Responsible Party):
Jiashang, Henan Provincial People's Hospital

Brief Summary:

This study evaluates whether addition of Peginterferon alfa-2a to CHB Patients Treated with nucleoside analogues (NAs) can enhance the rate of HBsAg clearance at end of treatment. This study is a Randomized, open-label, multi-center study.

The CHB patients with NAs treatment and have achieved HBV DNA <15 IU/ml、HBeAg <100 PEIU/ml、HBsAg positive and HBsAg<1500 IU/ml will be randomized into 2 groups:

Group 1 (Combination group): Maintain NAs treatment while add 48-week standard treatment by Peginterferon alfa 2a 180µg/week Group 2 (Mono NA group) : Maintain NAs treatment for 49 weeks. Note: NAs including: LAM, ADV, ETV, or TDF.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: Peginterferon alfa-2a Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Multi-center Clinical Trial to Evaluate Addition of Peginterferon Alfa-2a to CHB Patients Treated With NAs and Achieved HBV DNA<15 IU/ml、HBeAg<100 PEIU/ml、HBsAg Positive and HBsAg<1500 IU/ml.
Study Start Date : September 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Combination group
Maintain NAs treatment while add 48-week standard treatment by Peginterferon alfa 2a 180µg/week
Drug: Peginterferon alfa-2a
180ug/0.5ml,hypodermic injection once a week
Other Name: Pegasys

No Intervention: Mono NA group
Maintain NAs mono-therapy oral-daily for 48 weeks.

Primary Outcome Measures :
  1. The rate of HBsAg loss [ Time Frame: 48 weeks ]
    To determine the response rate will be evaluated by HBsAg loss defined as HBsAg level lower than 0.05 IU/ml after 48 week treatment, compared with control group.

Secondary Outcome Measures :
  1. Decline of HBeAg quantification [ Time Frame: 12 weeks, 24 weeks, 48 weeks of treatment ]
    Quantitative HBeAg reduction at Weeks 12, 24 and 48 compared with baseline level. Quantitative HBeAg value unit was calculated using 'Paul Ehrlich Institute units per millilitre' (PEIU/ml).

  2. Decline of HBsAg quantification [ Time Frame: 12 weeks, 24 weeks, 48 weeks of treatment ]
    Quantitative HBsAg reduction at Weeks 12, 24 and 48 compared with baseline level. Quantitative HBsAg calculated using 'International Units Per Millilitre' (IU/mL).

  3. The rate of HBeAg loss [ Time Frame: 48 weeks ]
  4. The rate of HBeAg seroconversion [ Time Frame: 48 weeks ]
  5. The rate of HBsAg seroconversion [ Time Frame: 48 weeks ]
  6. Sustained virological response rate [ Time Frame: 12 weeks, 24 weeks, 48 weeks of treatment ]
    Sustained virological response rate will be presented as rate of HBV DNA <15 IU/ml

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

Inclusion Criteria:

  • Male and female patients >18 and ≤65 years of age;
  • Diagnosed chronic hepatitis B (HBsAg(+) for over 6 months before nucleos(t)ide analogues treatment)
  • Patients had achieved HBV DNA<15 IU/ml、HBeAg<100 PEIU/ml、HBsAg positive and HBsAg<1500 IU/ml on treatment of Nucleoside (acid) Analogues (including LAM, ADV, ETV, and TDF )

Exclusion Criteria:

  • Decompensated liver disease: including ascites, hepatic encephalopathy, esophagogastric-varicosis and fissure bleeding and other decompensated complication;
  • Hypersensitive to interferon(IFN) or its active substance, and ineligible to IFN;
  • A history of immunoregulation drug therapy within 1 year before entry including IFN and so on;
  • Coinfection with HAV、HCV、HDV、HEV 、HIV or with Other chronic liver diseases such as Alcoholic Liver Disease,Inherited Metabolic Liver Disease,Drug induced Liver Disease and nonalcoholic fatty liver, autoimmune disease including autoimmune hepatitis and Psoriasis and so on;
  • Hepatocellular carcinoma(HCC) or alpha feto protein(AFP) levels more than 100ng/ml and Hepatic malignant potential of Imaging examination or AFP levels more than 100 ng/ml for 3 months;
  • A neutrophil count of less than 1500 per cubic millimeter or a platelet count of less than 90,000 per cubic millimeter;
  • A serum creatinine level that was more than 1.5 times the upper limit of the normal range;
  • With other malignant tumors(exclude the cured ones);
  • Severe organ dysfunction;
  • With severe psychiatric condition or nervous disease such as epilepsy, depression, mania, epilepsy, schizophrenia and so on;
  • Uncontrolled diabetes, hypertension or thyroid disease;
  • Pregnant women and lactating women or patients with pregnancy plans and not willing to use contraception during the study period;
  • Participate in other clinical studies at the same time;
  • Patients unsuitable for the research;

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 identifier (NCT number): NCT02894918

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China, Henan
Kaifeng Central Hospitl
Kaifeng, Henan, China
Weishi County People's Hospital
Kaifeng, Henan, China
Luoyang Central Hospital
Luoyang, Henan, China
Shangqiu No.1 People's Hospital
Shangqiu, Henan, China
Henan People's Hospital
Zhengzhou, Henan, China
Sponsors and Collaborators
Henan Provincial People's Hospital
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Principal Investigator: Jia Shang, M.D. Henan People's hospital
Publications of Results:
Ren H, Hu P, Jia S. et al. A multi-center randomized study on the efficacy and safety of switching to peginterferon a-2a(40KD) for 48 or 96 weeks in HBeAg positive CHB patients with a prior NUC history for 1-3 years: an interim analysis of NEW SWITCH study. 2014 AASLD. LB10.
Chi H, Xie Q, Zhang NP. et al. Addition of Peginterferon Alfa-2b During Long-term Nucleos(t)ide Analogue Therapy Increases HBeAg Seroconversion and HBsAg Decline - Week 48 Results From a Multicenter Randomized Controlled Trial (PEGON Study). 2014 AASLD ab.1882.
Marc Bourlière, Pascaline Rabiega. et al. HBsAg clearance after addition of 48 weeks of PEGIFN in HBeAg negative CHB patients on Nucleos(t)ide therapy with undetectable HBV DNA for at least one year: a multicenter randomized controlled phase III trial ANRS-HB06 PEGAN study: preliminary findings. 2014 AASLD ab1863.
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Responsible Party: Jiashang, M.D., Henan Provincial People's Hospital Identifier: NCT02894918    
Other Study ID Numbers: COMBINE
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: September 12, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents