Hepatitis C, ChronicSOF_GT2NCT03453346
Safety and Efficacy of Generic Sofosbuvir and Ribavirin for Treatment-naive Genotype 2 Chronic Hepatitis C
A study testing Sofosbuvir and Ribavirin in people with Hepatitis C, Chronic and Hepatitis C Virus Infection, Response to Therapy of, run by Kawin Technology Share-holding Co., Ltd. at 17 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C, Chronic, Hepatitis C Virus Infection, Response to Therapy of
- What is being tested?
- Sofosbuvir and Ribavirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 17 sitesChina
- Study dates
- 5 Aug 2016to 30 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 27Show fewer
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites
Chinese PLA 302 Hospital
Beijing, Beijing Municipality, 100039
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Capital Medical University Affiliated Beijing Youyi Hospital
Beijing, Beijing Municipality, 100050
Capital Medical University Affiliated Beijing You'an Hospital
Beijing, Beijing Municipality, 100069
Capital Medical University Affiliated Beijing Ditan Hospital
Beijing, Beijing Municipality, 100102
Jilin University First Hospital
Changchun, Jilin, 130021
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Chongqing Medical University Affiliated Second Hospital
Chongqing, Chongqing Municipality, 400010
Chinese PLA Third Military Medical University First Affiliated Hospital
Chongqing, Chongqing Municipality, 400038
Nanjing Municipal Second Hospital
Nanjing, Jiangsu, 210003
Qingdao Municipal Hospital
Qingdao, Shandong, 266011
Shenyang Municipal Sixth People's Hospital
Shenyang, Liaoning, 110006
Hebei Medical University Affiliated Third Hospital
Shijiazhuang, Hebei, 50051
Chinese PLA Fourth Military Medical University Tangdu Hospital
Xi'an, Shaanxi, 710038
Xi'an Jiaotong University College of Medicine Affiliated First Hospital
Xi'an, Shaanxi, 710061
He'nan Provincial People's Hospital
Zhengzhou, He'nan, 450003
He'nan Provincial Hospital of Infectious Disease (Zhengzhou Municipal Sixth People's Hospital)
Zhengzhou, He'nan, 450015
About this study
Official title: 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.
Read the 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.
- Being tested
- Sofosbuvir, Ribavirin
- Keywords
- Hepatitis C virus, Sofosbuvir, RNA polymerase inhibitor, Ribavirin, Genotype 2, Sustained virologic response, Confirmatory study
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SofosbuvirDrug
Also called SOF
Generic sofosbuvir tablet 400 mg
RibavirinDrug
Also called RBV
Ribavirin was provided in 100-mg tablets.
| Study group | Role | What they receive |
|---|---|---|
| Noncirrhotic and cirrhotic GT-2 | Experimental | 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 Receives: Drug: Sofosbuvir; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virologic response at 12 weeks after end of treatment (SVR12)
Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)
Measured: 12 weeks after end of treatment
Secondary outcomes (6)
Sustained virologic response at 4 weeks after end of treatment (SVR4)
Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)
Measured: 4 weeks after end of treatment
Rapid virologic response at 1 week after initiation of treatment (RVR1)
Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)
Measured: 1 week after initiation of treatment
Rapid virologic response at 2 weeks after initiation of treatment (RVR2)
Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)
Measured: 2 weeks after initiation of treatment
Rapid virologic response at 4 weeks after initiation of treatment (RVR4)
Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)
Measured: 4 weeks after initiation of treatment
Rapid virologic response at 8 weeks after initiation of treatment (RVR8)
Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)
Measured: 8 weeks after initiation of treatment
Rapid virologic response at 12 weeks after initiation of treatment (RVR12)
Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)
Measured: 12 weeks after initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start5 Aug 2016
- Primary completion18 Mar 2017
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, single arm, historical control
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kawin Technology Share-holding Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KawinGreen Biotech Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Lai Wei, M.D., Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453346
- Sponsor's protocol ID
- BJKY-2016-003
- Other IDs
- CTR20160399
- Acronym
- SOF_GT2
- Status last verified
- Mar 2018
- First submitted
- 27 Feb 2018
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD sharing plan was included in the study protocol.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03453346
- Acronym / sponsor ID
- SOF_GT2 / BJKY-2016-003
- Keywords
- Hepatitis C virus, Sofosbuvir, RNA polymerase inhibitor, Ribavirin, Genotype 2, Sustained virologic response, Confirmatory study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Kawin Technology Share-holding Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- KawinGreen Biotech Co., Ltd.
- Study start
- 5 Aug 2016 (actual)
- Primary completion
- 18 Mar 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 5 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, single arm, historical control
| Arm | Type | Receives |
|---|---|---|
| Noncirrhotic and cirrhotic GT-2 | Experimental | Drug: Sofosbuvir, Drug: RibavirinGeneric 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (27 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SofosbuvirAlso: SOFGeneric sofosbuvir tablet 400 mg | Drug | Noncirrhotic and cirrhotic GT-2 |
| RibavirinAlso: RBVRibavirin was provided in 100-mg tablets. | Drug | Noncirrhotic and cirrhotic GT-2 |
Primary outcome
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)
6 secondary outcomes
Sustained virologic response at 4 weeks after end of treatment (SVR4)
Time frame: 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
Rapid virologic response at 2 weeks after initiation of treatment (RVR2)
Time frame: 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
Rapid virologic response at 8 weeks after initiation of treatment (RVR8)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Individual participant dataSharing planned: No. No IPD sharing plan was included in the study protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lai Wei, M.D. principal investigator
Peking University People's Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sofosbuvir and Ribavirin in people with Hepatitis C, Chronic and Hepatitis C Virus Infection, Response to Therapy of, run by Kawin Technology Share-holding Co., Ltd. at 17 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained virologic response at 12 weeks after end of treatment (SVR12) (time frame: 12 weeks after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.