Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00014

2 Trial Registration Date

2005-09-05

i Registration Status

Retrospective

3 Secondary IDs

P03227

4 Source(s) of Funding

Hepatitis Research Fund

5 Primary Sponsor

Schering-Plough

6 Secondary Sponsor

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Angel Chim

ii Address

Room 36, 2/F, LSK Specialist Clinic South Wing, PWH;

iii Phone

Tel: 2632 4205;

iv Email

e-mail e-mail: angelchim@cuhk.edu.hk

v Affiliation

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Dr Henry LY Chan

ii Address

9/F Clinical Science Building, PWH; ;

iii Phone

Tel: 2632 3307

iv Email

e-mail e-mail: hlychan@cuhk.edu.hk

v Affiliation

vi Country

9 Official Scientific Title of the Study

A Study on the viral kinetics of different regimes of Pegylated Interferon and Lamivudine combination therapy in HBeAg Positive Chronic Heptatitis B

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2002-08-07

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Viral Diseases

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

PEG-Intron A 100mcq sc once weekly, Lamivudine 100mg QD

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

treatment period 104 weeks (include 32 doses of PEG-Intron A and 96 or 104 weeks Lamivudine)

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

one year treatment of Lamivudine 100mg QD

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion: 18 - 65 years of age; documented serum HBsAg positive for at least 6 months prior to screening; evidnece of HBV replicatioin documented by serum HBV DNA > 10^6 copies per me at screening; serum HBeAg positive at screening; presence of abnormal ALT (1.3-10XULN) at screening; WBC >= 4,000/mm^3; platelets >= 100,000/mm^3; bilirubin normal (except for Gilbert's disease); albumin stable and normal.

ii Exclusion Criteria

Exclusion: co-infection with hepatitis C virus and/ or HIV; evidence or history of decompensated liver disease

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Uncontrolled

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2002-12-13

21 Target Sample Size

30

22 Recruitment Status

Complete

23 Primary Outcome

Sustained complete response - normalization of ALT and negative HBV DNA 26 weeks after the cessation of treatment

24 Secondary Outcome

1. End-of-treatment complete response-normalization of ALT and negative HBV DNA at the end of treatment. 2. Viral response - negative HBV DNA at the end of treatment and 26 weeks after cessation of treatment. 3. Biochemical response - normalization of ALT at the end of treatment and 26 weeks after the cessaion of treatment. 4. Safety of treatment

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2011-03-02

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

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Trial History Detail on 2009-11-19