Clinical Trial Result Information

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.

Fast Facts:

Protocol number:	M78028
Sponsor:	Shanghai Roche Pharmaceutical Ltd
Company division:	Pharmaceutical
Product name:	PEGASYS
Generic name:	peginterferon alfa-2a (40KD)
Phase of development:	III
Therapeutic area, approved indication:	Hepatitis C, Chronic
Date of report:	9/15/2003

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.

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:
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Publications (references, if available):
1