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Trial record 83 of 339 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

The Optimizing Treatment of PegIFN Alfa in HBeAg-negative CHB Patients With Low Level HBsAg

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ClinicalTrials.gov Identifier: NCT02745704
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : May 22, 2018
Sponsor:
Collaborators:
Peking University
Huazhong University of Science and Technology
Nanchang University
Huizhou Municipal Central Hospital
First People's Hospital, Shunde China
Shenzhen Third People's Hospital
First People's Hospital of Foshan
Tang-Du Hospital
The First Affiliated Hospital of Kunming Medical College
Yuebei People's Hospital
Information provided by (Responsible Party):
Zhiliang Gao, Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary:
As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with sequential treatment of pegylated interferon alpha and NAs.

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

Detailed Description:
In order to optimize HBsAg clearance in CHB patients with low level HBsAg, the investigators enrolled patients who had received, and responded to, NAs for more than 12 months(see the inclusion criteria), and patients are switched to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 48 weeks and follow up for 24 weeks.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Optimizing Treatment of PegIFN Alfa in HBeAg-negative Chronic Hepatitis B Patients With Low Level HBsAg
Study Start Date : April 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PEG-IFN group
Hepatitis B e antigen (HBeAg)-negative CHB patients who had received NAs for more than 12 months, with HBsAg <1500 IU/ mL and Hepatitis B virus DNA not detectable, are to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 48 weeks.
Drug: Peginterferon alfa
peginterferon alfa-2b 80 micrograms/week or peginterferon alfa-2a 180 micrograms/week

No Intervention: NAs group
Patients do not need to change their NAs treatment.



Primary Outcome Measures :
  1. HBsAg Clearance [ Time Frame: 72 weeks ]
    Percentage of Participants with HBsAg negative.

  2. HBsAg Seroconversion [ Time Frame: 72 weeks ]
    Percentage of Participants with HBsAg negative and anti-HBsAg positive.



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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. CHB patients who had received NAs for more than 12 months.
  2. Hepatitis B e antigen (HBeAg)-negative and anti-HBeAg positive.
  3. Hepatitis B surface antigen (HBsAg) positive and <1500 IU/mL.
  4. Hepatitis B virus DNA not detectable(Roche Cobas).

Exclusion Criteria:

  1. Patients with liver cirrhosis, Hepatocellular Carcinoma or other malignancies.
  2. Patients with other factors causing liver diseases.
  3. Pregnant and lactating women.
  4. Patients with concomitant HIV infection or congenital immune deficiency diseases.
  5. Patients with diabetes, autoimmune diseases.
  6. Patients with important organ dysfunctions.
  7. Patients with serious complications (e.g., infection, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding.)
  8. Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months.
  9. Patients who can't come back to clinic for follow-up on schedule.

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): NCT02745704


Locations
China, Guangdong
The third affiliated hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Xiang Zhu, Doctor    13826452564    0628zhuxiang@163.com   
Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
Peking University
Huazhong University of Science and Technology
Nanchang University
Huizhou Municipal Central Hospital
First People's Hospital, Shunde China
Shenzhen Third People's Hospital
First People's Hospital of Foshan
Tang-Du Hospital
The First Affiliated Hospital of Kunming Medical College
Yuebei People's Hospital

Responsible Party: Zhiliang Gao, chief director of department of infectious disease, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02745704     History of Changes
Other Study ID Numbers: 3rd-SYSU-I-Cure
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Zhiliang Gao, Third Affiliated Hospital, Sun Yat-Sen University:
chronic hepatitis B
peginterferon alfa

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Peginterferon alfa-2b
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents