Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00013

2 Trial Registration Date

2005-09-05

i Registration Status

Retrospective

3 Secondary IDs

4 Source(s) of Funding

Hepatitis Research Fund

5 Primary Sponsor

Roche

6 Secondary Sponsor

Function

Please specify

7 Responsible 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

8 Research 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

Treatment with Peginterferon Alfa-2a (40 KD) (PEGASYS®) of Chronic Hepatitis B Patients, Who Have Failed Anti-Viral Treatment? A Pilot Study

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?

2005-01-03

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

Peginterferon Alfa-2a (40 KD) (PEGASYS®) 180 mcq per week

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

48 weeks

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: - age 18-70 - HBsAg positive for more than 6 months and detectable HBV DNA - previous use of nucleostide analogue for at least 12 months and the treatment has been stopped for at least 6 months - elevated serum ALT > 1.5X ULN but <= 10X ULN as determined by two abnormal values taken >= 14 days apart during the 6 months before the first dose of study drug with at least one of the determinations obtained during the sreening period Exclusions: - evidence of decompensated liver disease, HCC, pre-existing severe depression or other psyciatric disease, significant cardiac, significant renal disease, seizure disorder or severe retinopathy - positive test at screening for HIV or HCV - serum total bilirubin > 3X ULN at screening - neutrophil count < 1500 cells/mm^3 or platelet count < 90,000 cells/mm^3 at screening - hemoglobin < 11.5g/dL for females and < 12.5 g/dL for men at screening - serum creatinine level > 120umol/ml for men and > 105 umol/ml for women at screening

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Placebo

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

2005-04-15

21 Target Sample Size

49

22 Recruitment Status

Recruiting

23 Primary Outcome

- HBeAg positive patients response is defined as HBeAg loss and presence of anti-HBe (HBeAg seroconversion). - HBeAg Negative patients response is defined as DNA<20,000 copies/ml and ALT normalization both measured at week 72.

24 Secondary Outcome

1. Percentage of patients with HBV DNA levels <100,000 copies/ml at week 72. 2. Percentage of patients with HBV DNA levels <10,000 copies/ml at week 72 3. Percentage of patients with HBV DNA levels negative by PCR at week 72. 4. ALT normalization at week 72. 5. HBsAg seroconversion at week 72. 6. 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

None

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Trial History Detail on 2005-09-05