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

NCT01908335 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2014-10-20

No results posted yet for this study

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.

Conditions

  • Chronic Hepatitis C

Interventions

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

Sponsors & Collaborators

  • Beijing Kawin Technology Share-Holding Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Cheng jun, MD, PhD · Beijing Ditan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-08-31
Completion
2014-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01908335 on ClinicalTrials.gov