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Trial record 156 of 362 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

Addition of PegIFN Alfa-2a to CHB Patients Treated With Nucleot(s)Ides

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified December 2015 by Peng Hu, The Second Affiliated Hospital of Chongqing Medical University
Sponsor:
Collaborators:
People's Hospital of Guizhou Province
The First Affiliated Hospital of Nanchang University
First Affiliated Hospital of Xinjiang Medical University
Information provided by (Responsible Party):
Peng Hu, The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT02644538
First received: December 28, 2015
Last updated: December 30, 2015
Last verified: December 2015
  Purpose
This study evaluates whether PegIFN alfa-2a add on can improve CHB patients HBsAg clearance at the end of 48 weeks treatment. The CHB patients who received nucleot(s)ides anti-virus treatment and reached HBV DNA<1000 copies/ml and HBsAg<3000 IU/ml, were randomly assigned into two groups: One group continue the nucleot(s)ides treatment for 72 weeks, the other add on PegIFN alfa-2a on the basis of the original treatment for 48 weeks, and follow up for 24 weeks.

Condition Intervention Phase
Hepatitis B Drug: PegIFN alfa-2a Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Open-label, Multicenter Clinical Trial to Evaluate the Addition of PegIFN Alfa-2a to CHB Patients Treated With Nucleot(s)Ides

Resource links provided by NLM:


Further study details as provided by Peng Hu, The Second Affiliated Hospital of Chongqing Medical University:

Primary Outcome Measures:
  • Number of participants who achieve HBsAg clearance [ Time Frame: treat for 48 weeks ]
    To investigate whether Peg-IFN alfa-2a add on treatment can improve the HBsAg clearance in CHB patients at the end of the treatment (48 week).


Secondary Outcome Measures:
  • Number of participants who achieve HBsAg seroconversion [ Time Frame: 48 weeks ]
    To investigate whether Peg-IFN alfa-2a add on treatment can improve the HBsAg seroconversion in CHB patients at the end of the treatment (48 week).

  • Number of participants who achieve HBeAg clearance and seroconversion [ Time Frame: 48 weeks ]
    To investigate whether Peg-IFN alfa-2a add on treatment can improve HBeAg clearance and seroconversion at the end of the treatment (48 week).

  • 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

  • Number of participants who achieve HBV DNA<1000 copies/ml [ Time Frame: 12,24 and 48 weeks ]
    To investigate whether Peg-IFN alfa-2a add on treatment can improve HBV DNA<1000 copies/ml


Estimated Enrollment: 196
Study Start Date: December 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: nucleot(s)ides treated
patients who treated with nucleot(s)ides (including lamivudine, adefovir, entecavir, tenofovir) are still using the original treatment for 72 weeks
Active Comparator: PegIFN alfa-2a + nucleot(s)ides treated
patients who treated with nucleot(s)ides (including lamivudine, adefovir, entecavir, tenofovir), then will add PegIFN alfa-2a to the original nucleot(s)ides for 48 weeks, then follow up for 24 weeks
Drug: PegIFN alfa-2a
chronic hepatitis B patients who treated with nucleot(s)ides (including lamivudine, adefovir, entecavir, tenofovir) arrived HBV DNA <1000copies/ml, and HBsAg<3000IU/ml, then change the treatment to original nucleot(s)ides add on PegIFN alfa-2a, the combined treatment is for 48 weeks, and follow up for 24 weeks
Other Name: Pegasys

Detailed Description:
nucleot(s)ides is a potent inhibitor of hepatitis B viral(HBV) replication, but long-term therapy may be required, and it is difficult for CHB patients to achieve HBsAg clearance by using nucleot(s)ides. Therefore, it is need take long-term therapy if chronic hepatitis B (CHB) choose to use nucleot(s)ides, and in another way, nucleot(s)ides resistance is an important clinical risk. More and more young patients want to stop treating, and discontinuation of nucleot(s)ides is a feasible strategy to reduce resistance. However, it is really easy to relapse if patients did not arrive HBsAg clearance. PegIFN alfa-2a 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; and what's more, patients are safety after discontinuing.
  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 subjects,18-65 years
  2. positive for hepatitis B surface antigen (HBsAg) and negative for antibodies to HBsAg (anti-HBs antibodies) for at least 6 months before NAs treated
  3. nucleot(s)ides monotherapy (including lamivudine, adefovir, entecavir, tenofovir) and achieved HBV DNA<1000 copies/mL with HBsAg <3000 IU/mL, positive or negative for HBeAg, and negative for anti-HBs antibodies
  4. Subjects with no contra-indications to Peginterferon alfa therapy as detailed in the label (Hypersensitivity to the active substance, to alpha interferon, or to any of the excipients; Autoimmune hepatitis; Severe hepatic dysfunction or decompensated cirrhosis of the liver; A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months)
  5. Subjects who are not co-infected with Hepatitis A Virus, Hepatitis C Virus or HIV
  6. Female subjects not pregnant or breast feeding when Peginterferon alfa treatment commenced, and aware of the requirement to use an effective method of contraception during therapy
  7. Written informed consent signed.

Exclusion Criteria:

  1. positive for Hepatitis A Virus Ab, HCV-RNA or positive for Hepatitis C Virus Ab, HDV Ab, HEV Ab or positive for HIV Ab in screening period
  2. 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
  3. Compensated or Decompensated liver cirrhosis: with history of cirrhosis before nucleot(s)ides treatment or Child-Pugh score ≥ 5 or Complications of liver cirrhosis such as ascites, hepatic encephalopathy, esophageal gastric varices bleeding
  4. Autoimmune disease including Autoimmune hepatitis and Psoriasis and so on
  5. Pregnant women and lactating women or patients with pregnancy plans and not willing to use contraception during the study period
  6. A history of immunoregulation drug therapy within one year before entry including IFN and so on
  7. Have a history of alcohol abuse
  8. With severe psychiatric condition or nervous disease such as epilepsy, depression, mania, epilepsy, schizophrenia and so on
  9. A neutrophil count of less than 1500 per cubic millimeter or a platelet count of less than 90,000 per cubic millimeter
  10. Severe organ dysfunction
  11. With other malignant tumors(exclude the cured ones)
  12. Uncontrolled diabetes, hypertension or thyroid disease
  13. A serum creatinine level that was more than 1.5 times the upper limit of the normal range
  14. Hypersensitivity to interferon(IFN) or its active substance, and ineligible to IFN
  15. Participate in other clinical studies at the same time
  16. Patients unsuitable for the research -
  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.

No Contacts or Locations Provided
  More Information

Publications:

Responsible Party: Peng Hu, Director of Department of infection disease, The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT02644538     History of Changes
Other Study ID Numbers: APACE
Study First Received: December 28, 2015
Last Updated: December 30, 2015
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: still undecided

Keywords provided by Peng Hu, The Second Affiliated Hospital of Chongqing Medical University:
HBsAg clearance

Additional relevant MeSH terms:
Hepatitis B
Hepatitis, Viral, Human
Hepatitis
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Liver Diseases
Digestive System Diseases
Tenofovir
Peginterferon alfa-2a
Interferon-alpha
Adefovir
Entecavir
Lamivudine
Antiviral Agents
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 June 23, 2017