Efficacy and Safety Study of PEG-IFN-SA and Ribavirin to Treat Chronic Hepatitis C

September 24, 2015 updated by: Cheng jun, Beijing Kawin Technology Share-Holding Co., Ltd.

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

This study is to confirm the potential effects and assess the safety 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.

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.

Detailed Description

Total 720 subjects are divided into two groups and treated separately according to the HCV genotype（genotype 2,3 and non-genotype 2,3). With 2:1 ratio between experimental group and positive-control group (Peginterferon alfa-2a (Pegasys) plus RBV), 216 subjects for genotype 2,3 and 504 subjects for non-genotype2,3 will be enrolled. Accordingly, PEG-IFN-SA once weekly and RBV twice a day (bid) are given for 24 weeks and 48 weeks respectively to the HCV genotype 2,3 and the HCV non-genotype 2,3 .

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.
719

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 3

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 Ditan Hospital, Capital Medical University
      • Beijing, China
        • Beijing Youan Hospital, Capital Medical University
      • Beijing, China
        • Peking University People's Hospital
      • Beijing, China
        • 302 Military Hospital of China
      • Beijing, China
        • Beijing Youyi Hospital, capital Medical University
      • Beijing, China
        • General Hospital of Beijing Military Region
      • Chongqing, China
        • The Second Affiliated Hospital of Chongqing Medical University
      • Chongqing, China
        • Chongqing Southwest Hospital
      • Shanghai, China
        • Shanghai Public Health Clinical Center
      • Tianjin, China
        • Tianjin Infectious Disease Hospital
    • Gansu
      • Lanzhou, Gansu, China
        • First Affiliated Hospital of Lanzhou University
    • Guangdong
      • Guangzhou, Guangdong, China
        • Guangzhou Eighth People's Hospital
      • Guangzhou, Guangdong, China
        • Nanfang Hospital Southern Medical Unbiversity
    • Guangxi
      • Nanning, Guangxi, China
        • The First Affiliated Hospital of Guangxi Medical University
    • Hebei
      • Shijiazhuang, Hebei, China
        • Third Affiliated Hospital, Hebei Medical University
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • The Second Affiliated Hospital of Harbin Medical University
    • Henan
      • Xinxiang, Henan, China
        • The First Affiliated Hospital of Xinxiang Medical University
      • Zhengzhou, Henan, China
        • Henan Provincial People's Hospital
    • Hubei
      • Wuhan, Hubei, China
        • Tongji Hospital, Tongji Medical College Huazhong University of Science ＆ Technology
      • Wuhan, Hubei, China
        • Zhongnan Hospital of Wuhan University
      • Wuhan, Hubei, China
        • Union hospital, Tongji Medical College Huazhong University of Science ＆ Technology
    • Hunan
      • Changsha, Hunan, China
        • The Second Xiangya Hospital of Central South University
      • Changsha, Hunan, China
        • Xiangya Hospital Central-South University
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jiangsu Province Hospital
      • Nanjing, Jiangsu, China
        • The Second Hospital of Nanjing
    • Jiangxi
      • Nanchang, Jiangxi, China
        • First Affiliated Hospital of Nanchang University
    • Jilin
      • Changchun, Jilin, China
        • The first Affiliated Hospital of Jilin University
      • Yanji, Jilin, China
        • Yanbian University Hospital (Yanbian Hospital)
    • Liaoning
      • Shenyang, Liaoning, China
        • The Sixth People's Hospital of Shenyang
    • Shaanxi
      • Xi'an, Shaanxi, China
        • First Affiliated Hospital of Medical College of Xian jiaotong University
      • Xi'an, Shaanxi, China
        • Second Affiliated Hospital Of Medical College of Xian Jiaotong University
      • Xi'an, Shaanxi, China
        • Tangdu hospital,fourth military medical university
    • Shandong
      • Jinan, Shandong, China
        • Qilu Hospital of Shandong University
      • Jinan, Shandong, China
        • Jinan Infectious Disease Hospital
      • Qingdao, Shandong, China
        • Qingdao Municipal Hospital
    • Shanxi
      • Taiyuan, Shanxi, China
        • The First Hospital of Shanxi Medical University
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital, Sichuan University
      • Chengdu, Sichuan, China
        • Sichuan Academy of Medical Science ＆Sichuan Provincial People's Hospital
    • Xinjiang
      • Urumqi, Xinjiang, China
        • The First Teaching Hospital of Xinjiang Medical University
    • Zhejiang
      • Wenzhou, Zhejiang, China
        • The First Affiliated Hospital of Wenzhou Medical 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
  • Body Mass Index (BMI) 18-30
  • Chronic hepatitis C , diagnosed according to Chinese guideline of Hepatitis C (year 2004)
  • Detectable serum HCV-RNA by quantitative polymerase chain reaction assay and positive anti-HCV antibody
  • Female subjects of childbearing age with no history of menopause and negative pregnancy test, both female and male( including their partners ) subjects were required to conduct adequate contraception since screening until the 6 months after treatment
  • Volunteered to participate in this study, understood and signed an informed consent

Exclusion Criteria:

  • Previous IFN treated patients
  • Hepatotoxic drugs was systematically used more than two weeks within past 6 months
  • Systemic therapy with potent immunomodulatory agents such as adrenocorticotropic hormone, thymosin α1, etc more than two weeks within past 6 months, not including corticosteroid nasal sprays, inhaled steroids and / or topical steroids
  • Co-infection with HAV, HBV, HEV, EBV, CMV and HIV
  • Evidences of hepatic decompensation, including but not limited to serum total bilirubin> 2 times the upper limit of normal (ULN); serum albumin <35g/L; prothrombin activity (PTA) <60%; ascites, upper gastrointestinal bleeding and hepatic encephalopathy; Child-Pugh score B/C grade
  • Diagnosed with primary hepatocellular carcinoma or supported by evidences including but not limited to AFP> l00ng/ml, suspicious liver nodules by imaging examinations
  • Liver diseases from causes other than HCV infection, including alcoholic liver disease, non-alcoholic steatohepatitis, drug-induced hepatitis, autoimmune hepatitis (antinuclear antibody titer higher than 1:100), hepatolenticular degeneration (Wilson's disease) and hemochromatosis, etc.
  • White blood cell count <3×109/L; Neutrophil count<1.5×109/L; platelet count<90×109/L; hemoglobin below the lower limit of normal
  • Serum creatinine above the ULN
  • Serum creatine kinase> 3 ULN
  • Diabetes mellitus or Poorly controlled Thyroid Diseases
  • Poorly controlled hypertension (systolic blood pressure> 140mmHg, or diastolic blood pressure> 90 mmHg) with hypertension -related retinal lesions
  • Immunodeficiency or autoimmune diseases including but not limited to inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, scleroderma, Sjogren's syndrome, autoimmune thrombocytopenia, etc.
  • Psychiatric and nervous system disorders, including history of Psychiatric illness or with family history (especially depression, depressive tendencies, epilepsy and hysteria, etc.)
  • Severe cardiovascular diseases (New York Heart Association functional class (NYHA) Ⅲ level and above, myocardial infarction occurred within past 6 months or PTCA performed within past 6 months, unstable angina, uncontrolled arrhythmias)
  • Serious blood disorders (all kinds of anemia, hemophilia, etc.)
  • Severe kidney disease (chronic kidney disease, renal insufficiency, etc.)
  • Serious digestive diseases (gastrointestinal ulcers, colitis, etc.)
  • Severe respiratory disease (pneumonia, chronic obstructive pulmonary disease, interstitial lung disease, etc.)
  • Retinal disease (retinal exfoliation, macular hole, retinal tumors, etc.)
  • Malignancies
  • Function organs transplant
  • Allergies or severe allergies, especially allergic to study drugs or any ingredients of the study drugs
  • Evidence of alcohol or drug abuse (average alcohol consumption male> 40g / day, female> 20g / day)
  • Pregnant or lactating women
  • Usage of prohibition drugs in this study
  • Participated in other clinical trials 3 months prior to the screening
  • Unwilling to sign the informed consent and adhere to treatment requirements
  • Other conditions not suitable for study judged by investigators

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: PEG-IFN-SA /RBV T1(Genotype2,3)
PEG-IFN-SA/RBV, 1.5μg/kg/week im and RBV 1000mg-1200mg/d po bid（BW<75kg,1000mg/d; BW≥75kg, 1200mg/d）,24 weeks
Drug: PEG-IFN-SA /RBV
Active Comparator: Pegasys /RBV C1(Genotype 2,3)
Pegasys 180μg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW<75kg，1000mg/d；BW≥75kg，1200mg/d）for 24 weeks
Drug: Pegasys /RBV
Experimental: PEG-IFN-SA /RBV T2(Non-genotype 2,3)
PEG-IFN-SA 1.5μg/kg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW<75kg，1000mg/d；BW≥75kg，1200mg/d）for 48 weeks
Drug: PEG-IFN-SA /RBV
Active Comparator: Pegasys /RBV C2(Non-genotype 2,3)
Pegasys 180μg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW<75kg，1000mg/d；BW≥75kg，1200mg/d）for 48 weeks
Drug: Pegasys /RBV

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
SVR (sustained virologic response)
Time Frame: 24 weeks after 24 or 48 weeks of study therapy
defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at 24 weeks after the end of SVR (sustained virologic response) defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at 24 weeks after the end of treatment
24 weeks after 24 or 48 weeks of study therapy

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
RVR(rapid virologic response)
Time Frame: weeks 4 of study therapy
defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at weeks 4
weeks 4 of study therapy
cEVR (complete early virologic response)
Time Frame: weeks 12 of study therapy
defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at weeks 12
weeks 12 of study therapy
ETVR( end of treatment virologic response)
Time Frame: weeks 24 of study therapy for genotype 2,3, and weeks 48 of study therapy for non-genotype 2,3
defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at the end of treatment
weeks 24 of study therapy for genotype 2,3, and weeks 48 of study therapy for non-genotype 2,3
eRVR ( extended rapid virologic response)
Time Frame: weeks 4 and 12 of study therapy
defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at weeks 4 and 12
weeks 4 and 12 of study therapy
No-responses
Time Frame: weeks 12 or weeks 24 of study therapy
defined as the proportion of patients who had less than a <2 log IU/ml plasma HCV RNA decline at weeks 12 or had detectable plasma HCV RNA at weeks 24
weeks 12 or weeks 24 of study therapy
Breakthrough
Time Frame: weeks 12, 24 of study therapy for genotype 2,3, and weeks 12, 24 and 48 of study therapy for non-genotype 2,3
defined as the proportion of patients who had detectable plasma HCV RNA at any point during treatment after virological response( undetectable plasma HCV RNA)
weeks 12, 24 of study therapy for genotype 2,3, and weeks 12, 24 and 48 of study therapy for non-genotype 2,3
Relapse
Time Frame: 12 and 24 weeks after 24 or 48 weeks of study therapy
defined as the proportion of patients who had undetectable HCV RNA at the end of treatment, but reappearance of HCV RNA after the then
12 and 24 weeks after 24 or 48 weeks of study therapy

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cheng jun, MD, PhD, Beijing Ditan Hospital

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.
June 1, 2013

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.
August 1, 2015

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.
August 1, 2015

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).
July 17, 2013

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.
July 17, 2013

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.
July 19, 2013

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.
September 25, 2015

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.
September 24, 2015

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.
September 1, 2015

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.
  • KAWIN-002-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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