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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.
 
ClinicalTrials.gov 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
Sponsor:
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



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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:

  • 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 ClinicalTrials.gov identifier (NCT number): NCT02894918


Locations
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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
Investigators
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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.
Lozano R, Naghavi M, Foreman K, Lim S, Shibuya K, Aboyans V, Abraham J, Adair T, Aggarwal R, Ahn SY, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Barker-Collo S, Bartels DH, Bell ML, Benjamin EJ, Bennett D, Bhalla K, Bikbov B, Bin Abdulhak A, Birbeck G, Blyth F, Bolliger I, Boufous S, Bucello C, Burch M, Burney P, Carapetis J, Chen H, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahodwala N, De Leo D, Degenhardt L, Delossantos A, Denenberg J, Des Jarlais DC, Dharmaratne SD, Dorsey ER, Driscoll T, Duber H, Ebel B, Erwin PJ, Espindola P, Ezzati M, Feigin V, Flaxman AD, Forouzanfar MH, Fowkes FG, Franklin R, Fransen M, Freeman MK, Gabriel SE, Gakidou E, Gaspari F, Gillum RF, Gonzalez-Medina D, Halasa YA, Haring D, Harrison JE, Havmoeller R, Hay RJ, Hoen B, Hotez PJ, Hoy D, Jacobsen KH, James SL, Jasrasaria R, Jayaraman S, Johns N, Karthikeyan G, Kassebaum N, Keren A, Khoo JP, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Lipnick M, Lipshultz SE, Ohno SL, Mabweijano J, MacIntyre MF, Mallinger L, March L, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGrath J, Mensah GA, Merriman TR, Michaud C, Miller M, Miller TR, Mock C, Mocumbi AO, Mokdad AA, Moran A, Mulholland K, Nair MN, Naldi L, Narayan KM, Nasseri K, Norman P, O'Donnell M, Omer SB, Ortblad K, Osborne R, Ozgediz D, Pahari B, Pandian JD, Rivero AP, Padilla RP, Perez-Ruiz F, Perico N, Phillips D, Pierce K, Pope CA 3rd, Porrini E, Pourmalek F, Raju M, Ranganathan D, Rehm JT, Rein DB, Remuzzi G, Rivara FP, Roberts T, De León FR, Rosenfeld LC, Rushton L, Sacco RL, Salomon JA, Sampson U, Sanman E, Schwebel DC, Segui-Gomez M, Shepard DS, Singh D, Singleton J, Sliwa K, Smith E, Steer A, Taylor JA, Thomas B, Tleyjeh IM, Towbin JA, Truelsen T, Undurraga EA, Venketasubramanian N, Vijayakumar L, Vos T, Wagner GR, Wang M, Wang W, Watt K, Weinstock MA, Weintraub R, Wilkinson JD, Woolf AD, Wulf S, Yeh PH, Yip P, Zabetian A, Zheng ZJ, Lopez AD, Murray CJ, AlMazroa MA, Memish ZA. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2095-128. doi: 10.1016/S0140-6736(12)61728-0. Erratum in: Lancet. 2013 Feb 23;381(9867):628. AlMazroa, Mohammad A [added]; Memish, Ziad A [added].

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Responsible Party: Jiashang, M.D., Henan Provincial People's Hospital
ClinicalTrials.gov 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
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