NCT01908335

A Phase Ⅱ Dose-escalating Study of PEG-IFN-SA and Ribavirin in IFN Naive Patients With Chronic Hepatitis C

Phase Ⅱ, Multi-center, Randomized, Open-label, Parallel-group, Active Controlled Study for the Efficacy and Safety of Pegylated Recombinant Consensus Interferon Variant Solution for Injection in the Treatment of Chronic Hepatitis C

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 212 (actual)
• Sponsor: Beijing Kawin Technology Share-Holding Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This dose-escalating study is to evaluate the efficacy and the safety of different doses of a new bio-product Pegylated Recombinant Consensus Interferon Variant Solution for Injection (PEG-IFN-SA) and Ribavirin（RBV） in the treatment of Chronic hepatitis C who have not been previously treated with Interferon(IFN) by exploring the dose-effect relationship, while identity the optimal dose for phase Ⅲ study. In addition, population pharmacokinetic method is adopted to assess the pharmacokinetic behavior, individuals / intra-individual variability, and the possible factors for further study.

Detailed description

Total 200 subjects will be randomized and enrolled into four groups proportionally receiving experimental drug of high dose, middle dose, low dose and positive-control drug. Treatment duration will be 24 or 48 weeks corresponding to different HCV genotype, genotype 2,3 and non-genotype2,3.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	PEG-IFN-SA /RBV low dose	24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3
DRUG	PEG-IFN-SA /RBV middle dose	24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3
DRUG	PEG-IFN-SA /RBV high dose	24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3
DRUG	Pegasys /RBV	24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-08-01
• Completion: 2014-07-01
• First posted: 2013-07-25
• Last updated: 2014-10-20

Locations

52 sites across 1 country: China