Study on Treatment of Pegylated Interferon Alfa 2a(Pegasy... | NCT02822547

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

NCT02822547

Sponsor

Yonsei University

Status

Unknown status

Last Update Posted

Jul 4, 2016Estimated

Enrollment

253Estimated

Phase

Phase 4

Conditions

Chronic Hepatitis B

Interventions

Peginterferon alfa-2a

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Sep 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Jun 30, 2016

First Submission Date that Met QC Criteria

Jun 30, 2016

First Posted Date

Jul 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2016

Last Update Posted Date

Jul 4, 2016Estimated

Name	Class
Roche Pharma AG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

253Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Peginterferon alfa-2a	Experimental		Drug: Peginterferon alfa-2a

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Peginterferon alfa-2a	Drug	Patients will receive Peginterferon alfa-2a according to the standard medical practice	Peginterferon alfa-2a

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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

Secondary Outcomes

Measure	Description	Time Frame
The change of HBV DNA at Week 12 from baseline		12 week from baseline
The change of HBsAg at Week 4, 8, 12 from baseline		4, 8, 12 week from baseline
The change of ALT at week 4, 8, 12 from baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sang Hoon Ahn	Contact	82-2-2228-1936		ahnsh@yuhs.ac

Overall Officials

Name	Affiliation	Role
Sang Hoon Ahn	Severance Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Severance Hospital	Recruiting	Seoul	Seoul	120-752	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019694	Hepatitis B, Chronic

Ancestor Terms

ID	Term
D006509	Hepatitis B
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C100416	peginterferon alfa-2a

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided