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

iRegistration 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

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

i Name

Angel Chim

ii Address

iii Phone

Room 36, 2/F, LSK Specialist Clinic South Wing, PWH; Tel: 2632 4205; e-mail: angelchim@cuhk.edu.hk

iv Email

e-mail

v Affiliation

vi Country

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

i Name

Dr Henry LY Chan

ii Address

iii Phone

9/F Clinical Science Building, PWH; Tel: 2632 3307; e-mail: hlychan@cuhk.edu.hk

iv Email

e-mail

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

13Research 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

15Intervention

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

16Comparative 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

17Key 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 Exclusion: - co-infection with hepatitis C virus and/ or HIV - evidence or history of decompensated liver disease

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19Study 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 ¡V normalization of ALT and negative HBV DNA 26 weeks after the cessation of treatment

24 Secondary Outcome

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

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last 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

None

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Trial History Detail on 2005-09-05