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Trial record 64 of 309 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

Long-term Benefit in Chronic Hepatitis B Patients After Standard Peginterferon Alfa Therapy

This study is currently recruiting participants.
Verified June 2017 by Xiamen Amoytop Biotech Co., Ltd.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03181113
First Posted: June 8, 2017
Last Update Posted: June 8, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Peking University First Hospital
Information provided by (Responsible Party):
Xiamen Amoytop Biotech Co., Ltd.
  Purpose
In this cohort study, patients with chronic hepatitis B who prior participated in TB1211IFN study and received at least 39 doses of peginterferon alfa will be enrolled. HBsAg/anti-HBs level, HBeAg/anti-HBe level, Serum HBV DNA load and alanine transaminase level will be test every year from the second year to the fifth year after the ending of peginterferon alfa treatment, and long-term benefit of interferon treatment will be evaluated.

Condition Intervention
Hepatitis B Drug: Peginterferon Alfa-2B Drug: Peginterferon Alfa-2A

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Multi-center, Prospective Study to Acess Long-term Benefit in HBeAg Positive Chronic Hepatitis B Patients Who Previously Received Standard Peginterferon Alfa Therapy

Resource links provided by NLM:


Further study details as provided by Xiamen Amoytop Biotech Co., Ltd.:

Primary Outcome Measures:
  • rate of HBeAg seroconversion [ Time Frame: from the second year to the fifth year ]

Secondary Outcome Measures:
  • decent degree of HBeAg [ Time Frame: from the second year to the fifth year ]
  • decent degree of HBV DNA [ Time Frame: from the second year to the fifth year ]
  • rate of alanine aminotransferase normalization [ Time Frame: from the second year to the fifth year ]
  • rate of HBeAg loss [ Time Frame: from the second year to the fifth year ]
  • rate of HBV DNA undetectable [ Time Frame: from the second year to the fifth year ]
  • rate of HBeAg seroconversion [ Time Frame: from the second year to the fifth year ]

Biospecimen Retention:   Samples With DNA
plasma, hemocyte

Estimated Enrollment: 775
Actual Study Start Date: May 18, 2016
Estimated Study Completion Date: January 30, 2020
Estimated Primary Completion Date: January 30, 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
peginterferon alfa 2b Drug: Peginterferon Alfa-2B
pre-received standard peginterferon alfa-2b therapy
Other Name: pegberon
peginterferon alfa 2a Drug: Peginterferon Alfa-2A
pre-received standard peginterferon alfa-2a therapy
Other Name: pegasys

  Eligibility

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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic hepatitis B who previously participated in TB1211IFN study.
Criteria

Inclusion Criteria:

  • Understand and sign the informed consent form.
  • Participated in NCT01760122 study (TB1211IFN) and has received at least 39 doses of peginterferon.

Exclusion Criteria:

  • Conditions which in the opinion of the investigator should be precluded from the study(e.g., poor compliance).
  Contacts and Locations
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): NCT03181113


Contacts
Contact: Guiqiang Wang, MD 86592-6889121 clinical@amoytop.com

  Show 28 Study Locations
Sponsors and Collaborators
Xiamen Amoytop Biotech Co., Ltd.
Peking University First Hospital
Investigators
Principal Investigator: Guiqiang Wang, MD Peking University First Hospital
  More Information

Responsible Party: Xiamen Amoytop Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT03181113     History of Changes
Other Study ID Numbers: TB1510IFN
First Submitted: June 6, 2017
First Posted: June 8, 2017
Last Update Posted: June 8, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiamen Amoytop Biotech Co., Ltd.:
peginterferon alpha
HBeAg seroconversion
immune control

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
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs