Safety and Efficacy of Generic Sofosbuvir and Ribavirin for Treatment-naive Genotype 2 Chronic Hepatitis C
SOF_GT2
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
2 other identifiers
interventional
136
1 country
17
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2016
Shorter than P25 for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2017
CompletedFirst Submitted
Initial submission to the registry
February 27, 2018
CompletedFirst Posted
Study publicly available on registry
March 5, 2018
CompletedMarch 7, 2018
March 1, 2018
8 months
February 27, 2018
March 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
12 weeks after end of treatment
Secondary Outcomes (6)
Sustained virologic response at 4 weeks after end of treatment (SVR4)
4 weeks after end of treatment
Rapid virologic response at 1 week after initiation of treatment (RVR1)
1 week after initiation of treatment
Rapid virologic response at 2 weeks after initiation of treatment (RVR2)
2 weeks after initiation of treatment
Rapid virologic response at 4 weeks after initiation of treatment (RVR4)
4 weeks after initiation of treatment
Rapid virologic response at 8 weeks after initiation of treatment (RVR8)
8 weeks after initiation of treatment
- +1 more secondary outcomes
Other Outcomes (2)
Virologic breakthrough
2, 4, 8 and 12 weeks after initiation of treatment
Virologic relapse
4 and 12 weeks after end of treatment
Study Arms (1)
Noncirrhotic and cirrhotic GT-2
EXPERIMENTALGeneric 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
Interventions
Ribavirin was provided in 100-mg tablets.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Chinese PLA 302 Hospital
Beijing, Beijing Municipality, 100039, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Capital Medical University Affiliated Beijing Youyi Hospital
Beijing, Beijing Municipality, 100050, China
Capital Medical University Affiliated Beijing You'an Hospital
Beijing, Beijing Municipality, 100069, China
Capital Medical University Affiliated Beijing Ditan Hospital
Beijing, Beijing Municipality, 100102, China
Chongqing Medical University Affiliated Second Hospital
Chongqing, Chongqing Municipality, 400010, China
Chinese PLA Third Military Medical University First Affiliated Hospital
Chongqing, Chongqing Municipality, 400038, China
He'nan Provincial People's Hospital
Zhengzhou, He'nan, 450003, China
He'nan Provincial Hospital of Infectious Disease (Zhengzhou Municipal Sixth People's Hospital)
Zhengzhou, He'nan, 450015, China
Hebei Medical University Affiliated Third Hospital
Shijiazhuang, Hebei, 50051, China
Nanjing Municipal Second Hospital
Nanjing, Jiangsu, 210003, China
Jilin University First Hospital
Changchun, Jilin, 130021, China
Shenyang Municipal Sixth People's Hospital
Shenyang, Liaoning, 110006, China
Chinese PLA Fourth Military Medical University Tangdu Hospital
Xi'an, Shaanxi, 710038, China
Xi'an Jiaotong University College of Medicine Affiliated First Hospital
Xi'an, Shaanxi, 710061, China
Qingdao Municipal Hospital
Qingdao, Shandong, 266011, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lai Wei, M.D.
Peking University People's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2018
First Posted
March 5, 2018
Study Start
August 5, 2016
Primary Completion
March 18, 2017
Study Completion
March 30, 2017
Last Updated
March 7, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share
No IPD sharing plan was included in the study protocol.