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

October 16, 2014 updated by: Cheng jun, Beijing Kawin Technology Share-Holding Co., Ltd.

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

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.

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 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.

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.
212

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 Ditan Hospital, Capital Medical University
      • Beijing, China
        • Beijing Youan Hospital, Capital Medical University
      • Beijing, China
        • Peking Union Medical College Hospital
      • 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
      • Chongqing, China
        • Daping Hospital, Research Institute of Surgery Third Military Medical University
      • Shanghai, China
        • Shanghai Public Health Clinical Center
      • Shanghai, China
        • Ruijing Hospital, Shanghai Jiaotong University School of Medicine
      • Tianjin, China
        • Tianjin Infectious Disease Hospital
    • Fujian
      • Fuzhou, Fujian, China
        • The First Affiliated Hospital of Fujian Medical University
    • Gansu
      • Lanzhou, Gansu, China
        • First Affiliated Hospital of Lanzhou University
    • Guangdong
      • Guangzhou, Guangdong, China
        • Guangdong General Hospital
      • Guangzhou, Guangdong, China
        • Guangzhou Eighth People's Hospital
      • Guangzhou, Guangdong, China
        • Nanfang Hospital Southern Medical Unbiversity
      • Shenzhen, Guangdong, China
        • The Third People's Hospital of Shenzhen
    • 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
      • Harbin, Heilongjiang, China
        • The First 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
      • Zhengzhou, Henan, China
        • First Affiliated Hospital of Zhengzhou University
    • 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
      • Suzhou, Jiangsu, China
        • The First Affiliated Hospital of Suzhou University
    • 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
        • Shandong Provincial Hospital
      • 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
      • Hangzhou, Zhejiang, China
        • Xixi hospital of Hangzhou
      • 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
  • 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
  • Hepatotoxic drugs was used for a long time within past 6 months
  • 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 not within the normal range
  • Serum creatine kinase> 3 ULN
  • Positive thyroid antibodies (A-TPO, A-TG)
  • Therapy with potent immunomodulatory agents such as adrenocorticotropic hormone, thymosin α1 etc. within past 6 months or an anticipated usage during the period of study
  • Allergies or severe allergies, especially allergic to study drugs or any ingredients of the study drugs
  • Severe autoimmune diseases; psychiatric and nervous system disorders, including history of Psychiatric illness or with family history (especially depression, depressive tendencies, epilepsy and hysteria, etc.); Serious blood disorders (all kinds of anemia, hemophilia, etc.); Severe kidney disease (chronic kidney disease, renal insufficiency, etc.); poorly controlled digestive diseases; endocrine disorders such as thyroid disease and diabetes; severe respiratory disease (pneumonia, chronic obstructive pulmonary disease, interstitial lung disease, etc.); cardiovascular diseases (hypertension, uncontrolled coronary atherosclerotic heart disease, heart failure, etc.); retinal disease; malignancies; or unsuitable for study considered by clinician
  • Function organs transplant
  • 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: A (PEG-IFN-SA /RBV low dose)
PEG-IFN-SA 0.75μg/kg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW<75kg，1000mg/d；BW≥75kg，1200mg/d）
Drug: PEG-IFN-SA /RBV low dose
24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3
Experimental: B (PEG-IFN-SA /RBV middle dose)
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）
Drug: PEG-IFN-SA /RBV middle dose
24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3
Experimental: C (PEG-IFN-SA /RBV high dose)
PEG-IFN-SA 2.0μg/kg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW<75kg，1000mg/d；BW≥75kg，1200mg/d）
Drug: PEG-IFN-SA /RBV high dose
24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3
Active Comparator: D (Pegasys /RBV)
Pegasys 180μg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW<75kg，1000mg/d；BW≥75kg，1200mg/d）
Drug: Pegasys /RBV
24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3

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
cEVR (complete early virologic response)
Time Frame: weeks 12 of study therapy
defined as the proportion of patients who had undetectable plasma HCV RNA at weeks 12
weeks 12 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
Proportion of patients who had undetectable plasma HCV RNA
Time Frame: weeks 4, 24, 48 of study therapy and 24 weeks after the end of treatment
weeks 4, 24, 48 of study therapy and 24 weeks after the end of treatment
HCV RNA load reduction
Time Frame: weeks 4, 12, 24, 48 of study therapy and 24 weeks after the end of treatment
weeks 4, 12, 24, 48 of study therapy and 24 weeks after the end of treatment
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 at weeks 4 and 12
weeks 4 and 12 of study therapy
Breakthrough
Time Frame: weeks 24, 48 of study therapy
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 24, 48 of study therapy
Relapse
Time Frame: 12 and 24 weeks after the end of treatment
defined as the proportion of patients who had undetectable HCV RNA at the end of treatment, but reappearance of HCV RNA after then
12 and 24 weeks after the end of treatment

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.
October 1, 2012

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, 2013

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.
July 1, 2014

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 23, 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 23, 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 25, 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.
October 20, 2014

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.
October 16, 2014

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.
October 1, 2014

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-002-1

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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