Efficacy and Safety Study of Peginterferon Alfa-2b in Chinese Chronic Hepatitis C Patients

A Phase 3, Randomized, Multi-center, Active-Controlled, Open-label Study to Evaluate the Efficacy and Safety of Peginterferon Alfa-2b (40kD, Y Shape) in Combination With Ribavirin in Chinese Chronic Hepatitis C Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01581398

Enrollment

770

Registered

2012-04-20

Start date

2012-04-30

Completion date

2014-06-30

Last updated

2014-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

Peginterferon, Pegasys, Sustained virus response, HCV

Brief summary

The purpose of this study is to evaluate the efficacy and safety of Peginterferon alfa-2b (40KD, Y shape, the followings will refer as Ypeginterferon alfa-2b for short), at a dose of 180μg/week, in combination with Ribavirin in Chinese chronic hepatitis C patients. The study will first group patients into two sub-study, genotype 2/3 and non-genotype 2/3, depending on the HCV genotype that infected. In the genotype 2/3 sub-study about 219 patients will be enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group or active control group (Pegasys), receiving 24 weeks of interferon therapy and oral daily Ribavirin at a dose of 800mg/d. In the non-genotype 2/3 sub-study about 507 patients will be enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group or active control group (Pegasys), receiving 48 weeks of interferon therapy and oral daily Ribavirin 1000-1200mg/day , basing on body weight. All patients will be followed for 24 weeks after the end of therapy.

Interventions

DRUGYpeginterferon alfa-2b

sc, qw, 24 weeks.

DRUGPegasys

sc, qw, 24 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 18\ 65 years * Hepatitis virus C chronic infection evidences: HCV RNA or anti-HCV positive\>6 months,or other evidences supporting diagnosis of chronic hepatitis C infection * HCV RNA≥2000IU/mL, anti-HCV positive at screening * Pregnancy tests for female patients must be negative. All patients must take effective contraception measures during the study period * Signed informed consent

Exclusion criteria

* Pregnant or lactating women * Mental or psychology disorder * ANC\<1500/mm3, or PLT\<90,000/mm3, or Hb\<ULN(Upper limit of Normal) * Received interferon treatment within the previous 6 months or shown no-response to previous interferon treatment * Co-infection with HIV, HAV, HBV, HEV * Evidence of hepatic decompensation (e.g: Child Plug≥B, prothrombin time prolonged more than 3 seconds, TBil\>2ULN, Alb\<35g/L) * Hepatocarcinoma or suffering from any other malignant tumor * Not well controlled endocrine diseases(e.g:thyroid disfunction, mellitus mellitus) * Significant function damage in any major organs (e.g: heart, lung, kidney) * Involved in other investigation within the previous 3 months * Other conditions which in the opinion of the investigator precluding enrollment into the study (e.g: poor compliance)

Design outcomes

Primary

Measure	Time frame
Proportion of patients with sustained virologic response (defined as HCV RNA<15IU/ml at 24 weeks after the end of therapy)	24 weeks after the end of therapy

Secondary

Measure	Time frame
Proportion of patients with HCV RNA undetectable (defined as HCV RNA <15IU/ml)	at weeks 4, 12, 24 for genotype 2/3, and weeks 4, 12, 24 and 48 for non-genotype 2/3

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026