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

Chronic Hepatitis B Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02822547
• Other study ID #: ML29378
• Status: Recruiting
• Phase: Phase 4
• First received: June 30, 2016
• Last updated: June 30, 2016
• Start date: March 2015
• Est. completion date: December 2016

Study information

• Verified date: June 2016
• Source: Yonsei University
• Contact: Sang Hoon Ahn
• Phone: 82-2-2228-1936
• Email: ahnsh[@]yuhs.ac
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

Patients will receive Peginterferon alfa-2a according to the standard medical practice but the observation period is 12 weeks

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 253
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Peginterferon alfa-2a
Patients will receive Peginterferon alfa-2a according to the standard medical practice

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Yonsei University	Roche Pharma AG

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion subjects with HBsAg = 20,000 IU/mL at 12 week treatment of PEG-IFN in HBeAg-positive Chronic Hepatitis B		12 week from baseline	No
Primary	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		12 week from baseline	No
Secondary	The change of HBV DNA at Week 12 from baseline		12 week from baseline	No
Secondary	The change of HBsAg at Week 4, 8, 12 from baseline		4, 8, 12 week from baseline	No
Secondary	The change of ALT at week 4, 8, 12 from baseline		4, 8, 12 week from baseline	No
Secondary	The proportion of HBV DNA undetectable level (< 60 IU/mL, approximately 300 copies/mL) at week 12		12 week from baseline	No