Clinical Trial Result Information

Protocol number
M78028

Title of Study
A randomized, open, multicenter, efficacy and safety study comparing Peg-IFN alfa-2a to Roferon in the treatment of patients with chronic hepatitis C in China.

Sponsor
Shanghai Roche Pharmaceutical Ltd

Company division
Pharmaceutical

Product name
PEGASYS

Generic name
peginterferon alfa-2a (40KD)

Therapeutic area
Hepatitis C, Chronic

Clinical study summary
This multicenter, randomized, open-label study compared the efficacy and safety of subcutaneous (sc) peginterferon alfa-2a (PEGASYS) monotherapy 180 μg once weekly with sc Roferon-A 3 MIU three times weekly. Patients were randomized 1:1 into the PEGASYS or Roferon-A groups.

Study center(s)
8 sites in China.

Phase of development
III

Objectives
Primary: To compare the efficacy and safety of PEGASYS monotherapy with Roferon-A in the treatment of patients with chronic hepatitis C (CHC).

Secondary: To evaluate the safety and tolerability of PEGASYS.

Methodology
A total of 208 patients were randomly allocated to 1 of 2 treatment regimens: (A) PEGASYS for 48 weeks, plus an untreated 24 week follow-up period; (B) Roferon-A for 48 weeks, plus an untreated 24 week follow-up period. PEGASYS was administered sc once weekly, and Roferon-A was administered sc 3 times weekly. Patients were seen for evaluation at weeks 2 and 4, and then followed every 4 weeks through the 24 weeks of treatment, and every 8 weeks through the 24 week post-treatment period.

Number of patients (planned/analyzed)
208.

Diagnosis and main criteria for inclusion
Men and women, 18-65 years of age, with serologically proven CHC, serum HCV-RNA ≥ 1000copies/mL at screening, and elevated serum ALT > ULN but ≤ 10xULN at screening.

Test product, dose and mode of administration or test procedure
PEGASYS, 180 μg/sc/once weekly.

Duration of treatment
48 weeks

Reference therapy, dose and mode of administration or reference procedure
Roferon-A 3 MIU/sc/three times weekly

Criteria for evaluation (efficacy, safety)
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

Statistical methods
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

Summary (efficacy, safety, other results)
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

Conclusions
150617469656E74732077697468206368726F6E6963206865706174697469732043207472656174656420776974682050454741535953206D6F6E6F74686572617079206F6E63652061207765656B206163686965766564207375706572696F7220656666696361637920636F6D706172656420776974682070617469656E74732074726561746564207769746820526F6665726F6E2D41206D6F6E6F7468657261707920332074696D65732061207765656B2C20616E6420776974682073616665747920616E6420676F6F6420746F6C65726162696C6974792E

Publications (references, if available)
1

Date of report
9/15/2003