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Trial record 89 of 349 for:    hepatitis b | Open Studies

Study on Treatment of Pegylated Interferon Alfa 2a(Pegasys®) in the Korean Chronic Hepatitis B(CHB) Adults

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Yonsei University
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Sang Hoon Ahn, Yonsei University
ClinicalTrials.gov Identifier:
NCT02822547
First received: June 30, 2016
Last updated: NA
Last verified: June 2016
History: No changes posted
  Purpose
Patients will receive Peginterferon alfa-2a according to the standard medical practice but the observation period is 12 weeks

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study to Identify Eligible Subjects Using Response Guided Therapy-Stopping Rule for Treatment of Pegylated Interferon Alfa 2a(Pegasys®) in the Korean Chronic Hepatitis B(CHB) Adults.

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • The proportion subjects with HBsAg ≤ 20,000 IU/mL at 12 week treatment of PEG-IFN in HBeAg-positive Chronic Hepatitis B [ Time Frame: 12 week from baseline ] [ Designated as safety issue: No ]
  • The proportion subjects with any decline of HBsAg and/or HBV DNA decline more than 2 log copies/ml at 12 week treatment of PEG-IFN in HBeAg-negative CHB [ Time Frame: 12 week from baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change of HBV DNA at Week 12 from baseline [ Time Frame: 12 week from baseline ] [ Designated as safety issue: No ]
  • The change of HBsAg at Week 4, 8, 12 from baseline [ Time Frame: 4, 8, 12 week from baseline ] [ Designated as safety issue: No ]
  • The change of ALT at week 4, 8, 12 from baseline [ Time Frame: 4, 8, 12 week from baseline ] [ Designated as safety issue: No ]
  • The proportion of HBV DNA undetectable level (< 60 IU/mL, approximately 300 copies/mL) at week 12 [ Time Frame: 12 week from baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 253
Study Start Date: March 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peginterferon alfa-2a Drug: Peginterferon alfa-2a
Patients will receive Peginterferon alfa-2a according to the standard medical practice

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of HBsAg positive for more than 6 months
  • HBeAg-positive or HBeAg-negative within 8 weeks
  • Serum AST or ALT ≥ 80 IU/L
  • HBe-Ag positive patients: Serum HBV DNA ≥ 1.0 X 10^5 copies/mL (or 20,000 IU/mL)
  • HBeAg-negative patients: serum HBV DNA ≥ 1.0 X 10^4 copies/mL(or 2,000 IU/mL)

Exclusion Criteria:

  • History of antiviral therapy for Chronic hepatitis B within 6 months of study enrollment
  • Prior treatment of interferon
  • Presence of viral coinfections (hepatitis C, hepatitis delta, or human immunodeficiency virus)
  • Other chronic liver disease or decompensated liver disease
  • platelet<90,000/mm3 or absolute neutrophil count < 1,500 mm3
  • Pregnant or lactating woman
  • History of Organ transplantation
  • Treatment with immunosuppressive/immunomodulatory agents within 6 months prior to study entry
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02822547

Contacts
Contact: Sang Hoon Ahn 82-2-2228-1936 ahnsh@yuhs.ac

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Sang Hoon Ahn, M.D.Ph.D    +82-11-419-8087    ahnsh@yuhs.ac   
Contact: Jun Yong Park, M.D    +82-10-8353-0670    drpjy@yuhs.ac   
Principal Investigator: Jun Yong Park, M.D         
Sponsors and Collaborators
Yonsei University
Roche Pharma AG
Investigators
Principal Investigator: Sang Hoon Ahn Severance Hospital
  More Information

Responsible Party: Sang Hoon Ahn, Professor, Yonsei University
ClinicalTrials.gov Identifier: NCT02822547     History of Changes
Other Study ID Numbers: ML29378 
Study First Received: June 30, 2016
Last Updated: June 30, 2016
Health Authority: Korea: Ministry of Food and Drug Safety
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Interferons
Interferon-alpha
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016