Chronic hepatitis C
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients, 18-65 years of age; 2. Chronic hepatitis C with genotype 1 infection; 3. Detectable HCV RNA (HCV RNA >1000copies/ml); 4. Treatment Naive patients (no HCV antiviral treatment history); 5. Written informed consent signed.
Exclusion criteria
Exclusion criteria: 1. Pregnant orlactatingwomen; 2. The patients received antiviral treatment or immunotherapy before screening; 3. Co-infection with hepatitis A, B, D, E, and/or HIV; 4. Other liver diseases such as alcoholic liver disease, drug-induced hepatitis, Wilson disease and autoimmune hepatitis, cancer, decompensated liver disease and organ transplant patients; 5. Patients with severe neurological or psychological disease; 6. Uncontrolled thyroid diseases and other immunological diseases; 7. Uncontrolled hyperglycemia or hypoglycemia and diabetes; 8. Retinopathy and other ophthalmopathy; 9. Alcohol abuse and on temperance/drug addicts; 10. The baseline prior treatment should be platelet >=90000 cell/mm3, and ANC >=1500 cell/mm3; 11. Patients with a history of severe cardiac disease, coronary artery disease, cerebrovascular disease; 12. Failed with medication control of epilepsia; 13. Contra-indication to Peginterferonalfa therapy per theChina labeling and China HCV guideline; 14. Contra-indication to Vit D therapy per the labeling; 15. Or other conditions that investigator assessed should be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Virus response rate; | — |
Countries
China