Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C (PEGIFN)

January 31, 2013 updated by: Xiamen Amoytop Biotech Co., Ltd.

A Multi-center, Randomized, Open-label and Positive Controlled Phase II Clinical Trial to Assess Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C.

This study is a multi-center, randomized, open-label and positive controlled Phase II Clinical trial to assess the efficacy and safety of Ypeginterferon alfa-2b (with Ribavirin), once a week, in 3 dose-groups respectively, for treatment of Chronic Hepatitis C patients, with Pegasys 180mcg/week & Ribavirin as positive control. It is aimed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase III trials, and generate the PK data in hepatitis C patients to satisfy regulatory requirements.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
211

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking University First Hospital
      • Beijing, China
        • Beijing Youan Hospital, Capital Medical University
      • Beijing, China
        • Peking University People's Hospital
      • Beijing, China
        • 302 Military Hospital
      • Beijing, China
        • Beijing Youyi Hospital, capital Medical University
      • Changchun, China
        • First Affiliated Hospital of Jilin University
      • Changsha, China
        • Xiangya Hospital, Central-south University
      • Changsha, China
        • Xiangya Second Hospital, Central-south University
      • Chengdu, China
        • West China Hospital, Sichuan University
      • Chongqing, China
        • Southwest Hospital
      • Chongqing, China
        • Second Affiliated Hospital Chongqing Medical University
      • Fuzhou, China
        • Fuzhou Infectious Disease Hospital
      • Guangzhou, China
        • Guangzhou Eighth People's Hospital
      • Guangzhou, China
        • Nangfang Hospital
      • Guilin, China
        • First Affiliated Hospital of Guangxi Medical Universtiy
      • Harbin, China
        • Second Affiliated Hospital of Harbin Medical University
      • Hefei, China
        • First Affiliated Hospital of Anhui Medical University
      • Jinan, China
        • Jinan Infectious Disease Hospital
      • Lanzhou, China
        • First Affiliated Hospital of Lanzhou University
      • Nanchang, China
        • First Affiliated Hospital of Nanchang University
      • Nanjing, China
        • Jiangsu Province Hospital
      • Nanjing, China
        • Second Hospital of Nanjing
      • Nanjing, China
        • 81 Military Hospital
      • Shanghai, China
        • Ruijin Hospital
      • Shanghai, China
        • Renji hospital
      • Shanghai, China
        • Shanghai Public Health Clinical Center
      • Shanghai, China
        • Changhai Hospital
      • Shanghai, China
        • Huashan hospital
      • Shanghai, China
        • 85 Military Hospital
      • Shenzhen, China
        • Shenzhen Third People's Hospital
      • Shijiazhuang, China
        • Third Affiliated Hospital, Hebei Medical University
      • Taiyuan, China
        • First Affiliated Hospital, Shanxi University
      • Tianjin, China
        • Tianjin Third Central Hospital
      • Wenzhou, China
        • First Affiliated Hospital Of Wenzhou Medical College
      • Wuhan, China
        • Tongji Hospital, Huazhong University of Science&Technology
      • Xian, China
        • Tangdu Hospital, Fouth Military Medical University
      • Zhengzhou, China
        • Henan Provincial People's Hospital
      • Zhengzhou, China
        • First Affiliated Hospital of Zhengzhou University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 18~65 years.
  • Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the cessation of treatment.
  • Chronic HCV infection evidence: HCV RNA or anti-HCV positive >6 months; liver biopsy evidence; vital signs, symptoms, exposure history, and results of laboratory test and iconography examination support diagnosis of chronic hepatitis C.
  • HCV RNA≥2000IU/ml.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Mental disorder or physical disability.
  • WBC<3000/mm3, or ANC <1500/mm3, or PLT <90,000/mm3.
  • Received interferon treatment within the previous 6 months or shew no response to interferon.
  • Co-infection with HIV, HAV, HBV, HEV.
  • Evidence of hepatic decompensation.
  • Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease.
  • History of hypothyroidism or current treatment for thyroid disease.
  • Diabetes mellitus.
  • Uncontrolled significant chronic medical conditions other than chronic hepatitis C or other conditions which in the opinion of the investigator preclude enrollment into the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1
Ypeginterferon alfa-2b 90mcg per Week, with Ribavirin 1000-1200mg/d
Drug: Ypeginterferon alfa-2b
sc, qw, for 48 weeks.
Other Names:
  • Peginterferon alfa-2b
Experimental: Group 2
Ypeginterferon alfa-2b 135mcg per Week, with Ribavirin 1000-1200mg/d
Drug: Ypeginterferon alfa-2b
sc, qw, for 48 weeks.
Other Names:
  • Peginterferon alfa-2b
Experimental: Group 3
Ypeginterferon alfa-2b 180mcg per Week, with Ribavirin 1000-1200mg/d
Drug: Ypeginterferon alfa-2b
sc, qw, for 48 weeks.
Other Names:
  • Peginterferon alfa-2b
Active Comparator: Group 4
Pegasys 180mcg per Week, with Ribavirin 1000-1200mg/d
Drug: Peginterferon alfa-2a
sc, qw, for 48 weeks.
Other Names:
  • Pegasys

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: week 12
Proportion of patients with HCV RNA undetectable at week 12.
week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: Week 4, 12, 24, 48 and 72
  1. Proportion of patients with HCV RNA undetectable at Week 4, 24,48 and 72;
  2. Average decline level of log10 of HCV RNA at Week 4, 12, 24, 48 and 72.
Week 4, 12, 24, 48 and 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xiamen Amoytop Biotech Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Peking University People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TB1006IFN

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