Safety and Efficacy of Generic Sofosbuvir and Ribavirin for Treatment-naive Genotype 2 Chronic Hepatitis C (SOF_GT2)

March 5, 2018 updated by: Kawin Technology Share-holding Co., Ltd.

Evaluation of Safety and Efficacy of Generic Sofosbuvir and Ribavirin for Treatment-naive Adults Chronically Infected With Genotype 2 Hepatitis C Virus: an Open-label, Multicenter Confirmatory Study

This study aimed to evaluate the safety and efficacy of generic sofosbuvir, an investigational anti-hepatitis C virus (HCV) drug, combined with weight-adjusted ribavirin for treatment-naive Chinese adults chronically infected with genotype 2 HCV, the second most prevalent genotype in China. One hundred and thirty-two (132) subjects, including one hundred and twenty (120) non-cirrhotics and twelve (12) compensatory cirrhotics, were medicated with sofosbuvir 400 mg daily combined with weight-adjusted ribavirin 1000-1200 mg daily. The treatment course lasted 12 successive weeks and thereafter all the study participants entered into a 12-week treatment-free follow-up period.

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

It is estimated that China has a population of over 10 million infected with HCV and also a highly variable HCV genotype geographic distribution. Genotype 2 HCV is reported to be the second most common type (~25%) in Chinese population and associated with a high risk of acute liver disease exacerbation and other extrahepatic diseases. Sofosbuvir is a pan-genotypic HCV ribonucleic acid (RNA) polymerase inhibitor directing at HCV RNA replication. Genotype 2 chronic hepatitis C has a high treatment response to the combined regimen of peginterferon and weight-adjusted ribavirin. The all-oral combination regimen of sofosbuvir and ribavirin is expected to completely suppress genotype 2 HCV replication in subjects chronically infected with HCV and achieve a sustained virologic response, namely, HCV not detected or below a predefined limit in plasma, 12 or 24 weeks after cessation of treatment.

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.
136

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.
  • Not Applicable

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
      • Beijing, Beijing, China, 100044
        • Peking University People's Hospital
      • Beijing, Beijing, China, 100050
        • Capital Medical University Affiliated Beijing Youyi Hospital
      • Beijing, Beijing, China, 100069
        • Capital Medical University Affiliated Beijing You'an Hospital
      • Beijing, Beijing, China, 100039
        • Chinese PLA 302 Hospital
      • Beijing, Beijing, China, 100102
        • Capital Medical University Affiliated Beijing Ditan Hospital
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Chinese PLA Third Military Medical University First Affiliated Hospital
      • Chongqing, Chongqing, China, 400010
        • Chongqing Medical University Affiliated Second Hospital
    • Hebei
      • Shijiazhuang, Hebei, China, 50051
        • Hebei Medical University Affiliated Third Hospital
    • Henan
      • Zhengzhou, Henan, China, 450015
        • He'nan Provincial Hospital of Infectious Disease (Zhengzhou Municipal Sixth People's Hospital)
      • Zhengzhou, Henan, China, 450003
        • He'nan Provincial People's Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210003
        • Nanjing Municipal Second Hospital
    • Jilin
      • Changchun, Jilin, China, 130021
        • Jilin University First Hospital
    • Liaoning
      • Shenyang, Liaoning, China, 110006
        • Shenyang Municipal Sixth People's Hospital
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Chinese PLA Fourth Military Medical University Tangdu Hospital
      • Xi'an, Shaanxi, China, 710061
        • Xi'an Jiaotong University College of Medicine Affiliated First Hospital
    • Shandong
      • Qingdao, Shandong, China, 266011
        • Qingdao Municipal Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Sichuan Provincial People's Hospital

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:

  • aged between 18 and 65 years (inclusive) and of either sex
  • with a body mass index (BMI) between 18 and 30 kg/m^2
  • chronically infected with genotype 2 HCV, and the diagnosis of chronic hepatitis C consistent with the Chinese Guideline for Prevention and Management of Hepatitis C
  • HCV RNA equaling to or above 10^4 IU/mL and anti-HCV positivity
  • naive to anti-HCV treatment, defined as being not previously treated with any interferon (including interferon alfa or beta or peginterferon), ribavirin, or other approved, investigational or any other not approved anti-HCV regimens of any source
  • with or without cirrhosis, presence or absence of which must be documented as at lease one item of the following: 1) liver biopsy confirming presence (e.g., Metavir score = 4 or Ishak score >=5) or absence of cirrhosis within twelve (12) months before screening; 2) FibroScan showing cirrhosis (liver stiffness modulus [LSM]>=12.5 kPa) or no cirrhosis (LSM=<9.6 kPa); 3) a subject with a LSM of 9.6-12.5 kPa (exclusive) could only be enrolled when the liver biopsy confirmed or excluded presence of cirrhosis
  • women of childbearing potential without a history of menopause and with a negative blood pregnancy test; subjects of childbearing potential (including male subjects and their female partners) had no childbearing plan from screening, initiation of treatment until six (6) months after the end of treatment and consented to use effective contraceptive measures
  • voluntary participation in the study and being able to understand and sign the informed consent form

Exclusion Criteria:

  • being infected with mixed-genotype HCV
  • having previously used any investigational or experimental direct antiviral agents against HCV, including protease, nonstructural (NS) protein 5B polymerase or NS5A inhibitors, before screening
  • having received any interferon-based anti-HCV regimens before screening
  • having been exposed to any systemic potent immunomodulators , such as steroids or thymosin alfa (excluding use of nasal, inhalational, topical steroids and/or others) for more than two (2) weeks within six (6) months before screening, or anticipated to be exposed to these agents during the study period
  • being coinfected with hepatitis B virus (HBV) or human immunodeficient virus (HIV)
  • with evidence of decompensatory liver function, including but not limited to total serum bilirubin (TBIL) above twice (2) of the upper limit of normal (ULN), serum albumin (ALB) below 35 g/L, or prothrombin activity (PTA) below 60%; emergence of ascites, upper gastrointestinal bleeding and/or hepatic encephalopathy; with liver function reserve Child-Pugh class B or C
  • with primary liver cancer confirmed or evidenced by serum alfa-fetoprotein above 100 ng/ml or liver imaging study showing suspected nodules
  • with a previous history of liver disease of other causes, including alcoholic liver disease, nonalcoholic steatohepatitis, drug-induced hepatitis, autoimmune hepatitis (anti-nuclear antibody[ANA] titer above 1:100), Wilson disease or hemochromatosis
  • with serum alaine aminotransferase (ALT) or asparate aminotransferase (AST) above ten (10) times of ULN
  • with white blood cell (WBC) count below 3x10^9 per liter, neutrophil count below 1.5x10^9 per liter, platelet count below 50x10^9 per liter, or hemoglobin below the lower limit of the normal
  • with serum creatinine clearance (CLcr) below 50 ml/min using the Cockcroft-Gault formula
  • with uncontrolled diabetes mellitus (hemoglobin A1c[HbA1c] above 7.0%)
  • with psychiatric or neurologic disorders, including previous or family history of psychiatric disorders (especially depression, depressive state, epilepsy or hysteria)
  • with serious cardiovascular disorders, including uncontrolled hypertension (systolic blood pressure at or above 160 mmHg and/or diastolic blood pressure at or above 100 mmHg), heart insufficiency of New York Heart Association class III or above, history of myocardial infarction within six (6) months before screening, history of percutaneous transluminal coronary angioplasty within six (6) months before screening, unstable angina pectoris, or any uncontrolled arrhythmias
  • with serious hematologic disorders (such as anemia, hemophilia and others)
  • with serious kidney diseases (such as chronic kidney disease, kidney insufficiency and others)
  • with serious gastrointestinal disorders (such as peptic ulcer, colitis and others)
  • with serious respirator disorders (such as active pulmonary tuberculosis, lung infection, chronic obstructive pulmonary disease, pulmonary interstitial disease and others)
  • with active or suspected malignant tumors or with a previous history of malignant tumors (excluding skin basal cell carcinoma or cervical carcinoma in situ) within five (5) years before screening
  • with a history of major organ transplantation
  • being known to be severely hypersensitive or allergic to any drugs, especially the testing medications and other constituents
  • with a history of active alcohol or drug abuse
  • being pregnant or lactating
  • being unable to discontinue prohibited medications as defined by the protocol
  • having participated in any other clinical studies within three (3) months before screening
  • being unable or unwilling to provide informed consent or unable to follow the protocol requirements
  • any other conditions of excluding a potential participant at the discretion of the 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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

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: Noncirrhotic and cirrhotic GT-2
Generic sofosbuvir tablet 400 mg once daily plus weight-adjusted ribavirin tablet (1000 mg for <75 kg, and 1200 mg for >=75 kg) twice daily with meal, orally given, for 12 successive weeks
Drug: Sofosbuvir
Generic sofosbuvir tablet 400 mg
Other Names:
  • SOF
Drug: Ribavirin
Ribavirin was provided in 100-mg tablets.
Other Names:
  • 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
Sustained virologic response at 12 weeks after end of treatment (SVR12)
Time Frame: 12 weeks after end of treatment
Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)
12 weeks after end of treatment

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
Sustained virologic response at 4 weeks after end of treatment (SVR4)
Time Frame: 4 weeks after end of treatment
Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)
4 weeks after end of treatment
Rapid virologic response at 1 week after initiation of treatment (RVR1)
Time Frame: 1 week after initiation of treatment
Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)
1 week after initiation of treatment
Rapid virologic response at 2 weeks after initiation of treatment (RVR2)
Time Frame: 2 weeks after initiation of treatment
Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)
2 weeks after initiation of treatment
Rapid virologic response at 4 weeks after initiation of treatment (RVR4)
Time Frame: 4 weeks after initiation of treatment
Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)
4 weeks after initiation of treatment
Rapid virologic response at 8 weeks after initiation of treatment (RVR8)
Time Frame: 8 weeks after initiation of treatment
Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)
8 weeks after initiation of treatment
Rapid virologic response at 12 weeks after initiation of treatment (RVR12)
Time Frame: 12 weeks after initiation of treatment
Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)
12 weeks after initiation of treatment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Virologic breakthrough
Time Frame: 2, 4, 8 and 12 weeks after initiation of treatment
Percentage of subjects with on-treatment re-detected plasma HCV RNA after HCV RNA below the lower limit of quantitation
2, 4, 8 and 12 weeks after initiation of treatment
Virologic relapse
Time Frame: 4 and 12 weeks after end of treatment
Percentage of subjects with off-treatment re-detected plasma HCV RNA after end-of-treatment HCV RNA below the lower limit of quantitation
4 and 12 weeks after 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.
Kawin Technology Share-holding 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.
KawinGreen Biotech Co., Ltd.

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 (ACTUAL)

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.
August 5, 2016

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.
March 18, 2017

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 30, 2017

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).
February 27, 2018

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.
February 27, 2018

First Posted (ACTUAL)

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.
March 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

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.
March 7, 2018

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.
March 5, 2018

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.
March 1, 2018

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.
  • BJKY-2016-003
  • CTR20160399 (REGISTRY: China Drug Trials)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD sharing plan was included in the study protocol.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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