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Pegylated Interferon(Peg-IFN) in Reducing Relapse Rate in Patients After Discontinuation of NUC Therapy

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ClinicalTrials.gov Identifier: NCT02594293
Recruitment Status : Unknown
Verified April 2017 by Jiming Zhang, Huashan Hospital.
Recruitment status was:  Recruiting
First Posted : November 3, 2015
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Jiming Zhang, Huashan Hospital

Brief Summary:

This study evaluates whether Peg-IFN alfa-2a can reduce the recurrence rate of hepatitis B in 96 weeks after nucleoside analogue (NUC) withdrawal.

The HBV HBeAg-Negative patients who received NUC anti-virus treatment for 2.5 years and reached stopping rule in 《Chinese chronic hepatitis B prevention and treatment guidelines》(2010) were randomly assigned into three groups: One group discontinue the NUC treatment and follow up for 96 weeks,One discontinue the NUC treatment ,receive Peg-IFN alfa-2a 180 μg by week for 24 weeks and follow up for 72 weeks,The other discontinue the NUC treatment ,receive Peg-IFN alfa-2a 180 μg by week for 48 weeks and follow up for 48 weeks.


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

Detailed Description:

NUC is a potent inhibitor of hepatitis B viral(HBV) replication, but long-term therapy may be required. Therefore, NUC resistance is an important clinical risk resulting from long-term therapy in chronic hepatitis B (CHB) management. Discontinuation of NUC is a feasible strategy to reduce resistance. However, the high rate of relapse after cessation of NUC treatment in CHB patients remains a big problem. NUC treatment of how to safely stop drug needs to be solved.

Peg-IFN can clear HBV by direct anti-viral and immune regulation mechanisms including enhancing natural killer cell response, increased cluster of differentiation 8(CD8 +) T lymphocytes and other mechanisms to restore and enhance the immune response in patients with CHB. Response to PEG-IFN is frequently sustained after a finite treatment course due to its immune modulating capacity.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective, Randomized, Controlled Clinical Trial to Evaluate the Role of Peg-IFN Alfa-2a in Reducing RelapSe Rate in Patients With Hepatitis B e Antigen(HBeAg)-nEgative Chronic Hepatitis B After Discontinuation of NUC Therapy
Study Start Date : October 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Controlled Group
Discontinue the NA treatment and follow up for 96 weeks
Experimental: Pegasys 24 weeks
Discontinue the NA treatment ,PegIFN alfa-2a 180 μg by week for 24 weeks and follow up for 72 weeks
Drug: PegIFN alfa-2a
180 μg/ 0.5 ml ,hypodermic injection once a week
Other Name: Pegasys

Experimental: Pegasys 48 weeks
Discontinue the NA treatment ,PegIFN alfa-2a 180 μg by week for 48 weeks and follow up for 48 weeks
Drug: PegIFN alfa-2a
180 μg/ 0.5 ml ,hypodermic injection once a week
Other Name: Pegasys




Primary Outcome Measures :
  1. Number of participants who relapse [ Time Frame: 96 weeks ]
    The total number of relapse (HBV DNA>2000 IU/ml on 2 separate occasions 1 months apart) during the research period.


Secondary Outcome Measures :
  1. Number of participants who relapse [ Time Frame: 48 weeks ]
    The total number of relapse (HBV DNA>2000 IU/ml on 2 separate occasions 1 months apart) during the research period.

  2. Number of participants who achieve HBsAg seroconversion [ Time Frame: At the point of discontinuation of PegIFN therapy ]
    To investigate whether Peg-IFN alfa-2a can improve the HBsAg seroconversion in CHB patients at the point of discontinuation of PegIFN therapy compared to the control group ,which will be measured by the number of participants who achieve HBsAg seroconversion. Pegasys 24 weeks Group:24 weeks and Pegasys 48 weeks Group:48 weeks

  3. Number of participants who achieve HBsAg seroconversion [ Time Frame: 24,48,72 weeks post-discontinuation of PegIFN therapy ]
    To investigate whether Peg-IFN alfa-2a can improve the HBsAg seroconversion in CHB patients at 24,48 or 72 weeks post-discontinuation of PegIFN therapy compared to the control group ,which will be measured by the number of participants who achieve HBsAg seroconversion. Pegasys 24 weeks Group:48,72,96 weeks and Pegasys 48 weeks Group:72,96 weeks

  4. HBsAg changes from Baseline [ Time Frame: 12,24 and 48 weeks ]
    Pegasys 24 weeks Group:12,24 weeks and Pegasys 48 weeks Group:12,24,48 weeks

  5. Predictive value of other markers for recurrence after NUC withdrawal [ Time Frame: 48 weeks and 96 weeks ]
    To investigate whether the other markers including HBcAb quantification and so on can predict the recurrence of hepatitis B.



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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. HBeAg-Negative Chronic Hepatitis B Patients:HBsAg-Positive,HBsAb-Negative,HBeAg-Negative,HBeAb-Positive during screening period and before NA treatment
  2. NUC monotherapy (including adefovir and entecavir) for more than 2.5 years,and reached stopping rule in 《Chinese chronic hepatitis B prevention and treatment guidelines》(2010):the patients who achieved undetectable HBV DNA (<300 copies/mL) with normal alanine aminotransferase (ALT) and the consolidation therapy reached 1.5 years ,total course of the treatment reached 2.5 years can stop NUC therapy
  3. Willing to stop the drug, and signed a written informed consent

Exclusion Criteria:

  1. HBsAb positive in screening period
  2. Compensated or Decompensated liver cirrhosis:with history of cirrhosis before NUC treatment or Child-Pugh score ≥ 5 or Complications of liver cirrhosis such as ascites, hepatic encephalopathy, esophageal gastric varices bleeding
  3. Hypersensitivity to interferon(IFN) or its active substance, and ineligible to IFN
  4. A history of immunoregulation drug therapy within one year before entry including IFN and so on.
  5. 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
  6. Autoimmune disease including Autoimmune hepatitis and Psoriasis and so on.
  7. Hepatocellular carcinoma(HCC) or alpha feto protein(AFP) levels more than 100 ng/ml and Hepatic malignant potential of Imaging examination or AFP levels more than 100 ng/ml for 3 months
  8. A neutrophil count of less than 1500 per cubic millimeter or a platelet count of less than 90,000 per cubic millimeter
  9. A serum creatinine level that was more than 1.5 times the upper limit of the normal range
  10. With other malignant tumors(exclude the cured ones)
  11. Severe organ dysfunction
  12. With severe psychiatric condition or nervous disease such as epilepsy, depression, mania, epilepsy, schizophrenia and so on
  13. Uncontrolled diabetes, hypertension or thyroid disease
  14. Pregnant women and lactating women or patients with pregnancy plans and not willing to use contraception during the study period
  15. Participate in other clinical studies at the same time
  16. 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): NCT02594293


Contacts
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Contact: Jiming Zhang, M.D. jmzhang2006@gmail.com

Locations
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China, Hubei
Wuhan Seventh People's Hospital Not yet recruiting
Wuhan, Hubei, China
Contact: Youqin Yan         
Principal Investigator: Youqin Yan         
China, Jiangsu
Changzhou Third People's Hospital Recruiting
Changzhou, Jiangsu, China
Contact: Longgen Liu         
Principal Investigator: Longgen Liu         
First Affiliated Hospital of Zhejiang University Recruiting
Hangzhou, Jiangsu, China
Contact: Yida Yang         
Principal Investigator: Yida Yang         
People's Hospital of Jiangsu Province Recruiting
Nanjing, Jiangsu, China
Principal Investigator: Jun Li         
Nantong Third People's Hospital Recruiting
Nantong, Jiangsu, China
Contact: Songping Huang         
Principal Investigator: Songping Huang         
Suzhou Fifth People's Hospital Recruiting
Suzhou, Jiangsu, China
Contact: Chuanwu Zhu         
Principal Investigator: Chuanwu Zhu         
The First Affiliated Hospital of Soochow University Not yet recruiting
Suzhou, Jiangsu, China
Contact: Weifeng Zhao         
Principal Investigator: Weifeng Zhao         
Taicang People's Hospital Not yet recruiting
Taicang, Jiangsu, China
Contact: Yonglan Pu         
Principal Investigator: Yonglan Pu         
Wuxi Infectious Disease Hospital Recruiting
Wuxi, Jiangsu, China
Contact: Lihua Huang         
Contact: Huan         
Principal Investigator: Lihua Huang         
Affiliated Hospital of Xuzhou Medical College Not yet recruiting
Xuzhou, Jiangsu, China
Contact: Xiucheng Pan         
Principal Investigator: Xiucheng Pan         
China, Shandong
Shandong Provincial Hospital Not yet recruiting
Jinan, Shandong, China
Contact: Wanhua Ren         
Principal Investigator: Wanhua Ren         
China, Zhejiang
The First Affiliated Hospital of Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China
Contact: Qingxing Li         
Principal Investigator: Qingxing Li         
Principal Investigator: Ji Li         
China
Changhai Hospital Affiliated to Second Military Medical University Not yet recruiting
Shanghai, China
Contact: Chengzhong Li         
Principal Investigator: Chengzhong Li         
Huashan Hospital Affiliated to Fudan University Recruiting
Shanghai, China
Contact: Jiming Zhang, M.D.         
Principal Investigator: Jiming zhang, M.D.         
Ruijin Hospital Affiliate to Shanghai Jiao Tong University School of Medicine Not yet recruiting
Shanghai, China
Contact: Xinxin Zhang         
Principal Investigator: Xinxin Zhang         
Shanghai Public Health Clinical Center Not yet recruiting
Shanghai, China
Contact: Jiefei Wang         
Principal Investigator: Jiefei Wang         
Shanghai Third People's Hospital Not yet recruiting
Shanghai, China
Contact: Jie Xu         
Principal Investigator: Jie Xu         
Shuguang Hospital Affiliate to Shanghai University of Traditional Chinese Medicine Not yet recruiting
Shanghai, China
Contact: Yueqiu Gao         
Principal Investigator: Yueqiu Gao         
The Infectious Disease Hospital of Shanghai Huangpu Distric Recruiting
Shanghai, China
Contact: Hailin Liang         
Principal Investigator: Hailin Liang         
Sponsors and Collaborators
Huashan Hospital
Investigators
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Principal Investigator: Jiming Zhang, M.D. Huashan Hospital

Publications of Results:
中华医学会肝病学分会,中华医学会感染病学分会.慢性乙型肝炎防治指南(2010年版).中华内科杂志,2011;50(2):168-179

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Responsible Party: Jiming Zhang, chief physician,professor, Huashan Hospital
ClinicalTrials.gov Identifier: NCT02594293     History of Changes
Other Study ID Numbers: CEASE
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
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