HCV
Conditions
Interventions
Case series:12 weeks treatment, 12weeks follow-up
Sponsors
the 2nd affiliated hospital of Chongqing Medical School
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years old or above, male of female; 2. The body mass index (BMI) at screening is =18kg/m2 and <30kg/m2; 3. HCV RNA at screening is = 1×10^4IU/mL; 4. Genotype at screening is genotype 1; 5. Confirmation of chronic HCV infection must meet one of conditions below: (1) Confirmed HCV infection =6 months before baseline, including HCV antibody positive or HCV RNA positive for at least 6 months; (2) Liver biopsy prove chronic HCV infection one year before baseline; 6. CHC patients experienced DAA failure must have paper (ie, medical record, drug purchase receipt, etc.) to demonstrate that the patient has received DAA regime (NS3/4A targeted DAA excluded) before: (1) For patients experienced DAA failure, the treatment has to be discontinued at least 4 weeks before screening; (2) For patients who confirmed to have virologic breakthrough or whose HCV RNA decrease is less than 2 log during the treatment of DAA regime (NS3/4A targeted DAA excluded), the treatment has to be discontinued at least 4 weeks before screening; 7. The confirmation of non-cirrhotic must meet one of the conditions below: Liver biopsy proves no liver cirrhosis within 2 years before baseline (Metavir score =3. See the details of scoring in Appendix 2). Fibroscan = 12.5kPa when screening; 8. For female with fertility (18 years old to one year after menopause), pregnancy test must be negative when screening; 9. Male participants and female participants with fertility must concur that physical contraception will be conducted when intercourse from the screening to at least 6 months after the discontinuation of administration; 10. Participants must be compliant with the administration guidance and visit plan so as to complete study evaluation; 11. All participants must sign informed consent.
Exclusion criteria
Exclusion criteria: 1. HCV genotype 2~7 or unconfirmed genotype or mixed genotype HCV infection (mixed HCV subgenotype of genotype 1 excluded). 2. Patients with Fibroscan =12.5kPa, or patients with liver cirrhosis by radiological or histopathological ways. 3. Patients with chronic liver disease not caused by HCV now or before (ie, hemochromatosis, autoimmune hepatitis, Wilson's disease, a1-antitrypsin deficiency, alcoholic liver disease, drug-induced liver disease, etc.). 4. Decompensated liver disease now or before like Child-Pugh score B or C (See the score standard in Appendix 2), ascites, diuretics usage for ascites treatment, hepatic encephalopathy or variceal bleeding. 5. Patients have gastrointestinal disorder or post-surgery conditions which may intervene the absorption of study drug. 6. Hospitalization in psychological ward, suicide intention and/or disability for metal reasons during past 5 years. Participants with mental condition (not mentioned before) can be included if the condition is well controlled by therapy or not necessary to take medicine for least 12 months before baseline. 7. Patients with uncontrolled severe cardiovascular desease (ie. ventricular tachyarrhythmia, myocardial infarction, angina pectoris, coronary artery disease, etc.), or patients with uncontrolled hypertension (systolic pressure = 160mmHg and/or diastolic pressure = 100mmHg), or abnormal ECG manifestation with clinical significance. 8. Patients with severe conditions in respiratory or urinary systems. 9. Patients with severe hematological conditions or increased risk of anemia (ie, thalassemia, sickle cell anemia, spherocytosis, history of gastrointestinal bleeding, etc.). 10. Patients with uncontrolled diabetes or other endocrine conditions. 11. Patients with history of malignant tumor 5 years before screening or suspicious malignant tumor, certain cancer cured by surgery (like basal cell skin cancer) is not a part of it. 12. Patients received or planning to receive organ transplant, cornea transplant or bone marrow transplant during the study. 13. Patients with history of severe allergy to medicine, or patients allergic to study drugs or their metabolites. 14. Patients with uncontrolled autoimmune diseases including but not limited to: Myositis, hepatitis, interstitial lung disease, interstitial nephritis, immune (primary) thrombocytopenic purpura, systemic lupus erythematosus, thyroiditis, psoriasis, rheumatoid arthritis. 15. Positive anti-HAV(IgM), HBsAg, anti-HEV(IgM) or anti-HIV. 16. Any abnormal test result below: ALT > 10×ULN; AST > 10×ULN; Direct bilirubin > 1.5×ULN; Albumin 1.5×ULN, unless the participants have known hemophilia or stable to anti-clotting therapy influencing INR; Serum creatinine =1.5×ULN; Glycated hemoglobin > 7.0%; Hemoglobin: female <110g/L, male <120g/L; Absolute neutrophil count < 1.5×10^9/L; Platelet count < 100×10^9/L; Serum alpha-fetoprotein =100ng/ml; 17. Any simultaneous administration of forbidden drug during signing of informed consent till treatment cessation; 18. Blood donation or non-physiology bleeding over 400mL within 2 months of screening; 19. Pregnant or breast-feeding (non-breast-feeding excluded) females; 20. Patients with history of alcohol abuse, drug addict or drug abuse which may impact the result of study; 21. Patients who have taken part in other clinical trial and received medicine treatment 3 months before screening; 22. Patients are t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SVR; | — |
Secondary
| Measure | Time frame |
|---|---|
| HCV RNA; | — |
Countries
China
Contacts
Public ContactHu Peng
The 2nd Affiliated Hospital of Chongqing Medical School
Outcome results
None listed