Hepatic Fibrosis
Conditions
Interventions
Case series:Ganlong capsule
Sponsors
The 2nd People's Hospital Yunnan Province
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years male and female; 2. Hepatic fibrosis patients: Hepatic fibrosis is defined as conformance with one of the following conditions: (1) vefied to be hepatic fibrosis in hepatic tissue biopsy of baseline (1=Metavir fibrosis score =3 scores, with scoring method shown in Annex 2); (2) Fibro-Touch detection value (LSM) of screening period 7.3=LSM<17.5kPa; (3) Fibro-Touch detection value of screening period <7.3kPa but =17.5kPa, then it needs to be proved to be hepatic fibrosis (1=Metavir fibrosis score =3 scores) by hepatic tissue biopsy. If result of hepatic tissue biopsy is inconsistent with Fibro-Touch detection value, it shall be subject to result of hepatic tissue biopsy. 3. Patients signing informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Positive subjects in one of anti-HIV; 2. Patients with Fibro-Touch detection value=17.5kPa or 100ng/ml at the time of screening; 4. BMI32kg/m2; 5. ANC1.5; Cr>1.5ULN; 6. Patients with or once with mental disease in nervous system and/or mental system, poor self-control, and disability to exactly express intention; 7. Patients with existing serious CVD not controlled well (such as ventricular fast arrhythmia, myocardial infarction, angina, CAD, etc.); patients with existing high blood pressure not controlled well (systolic pressure=160mmHg and/or diastolic pressure=100mmHg); or patients with abnormal ECD examination results with clinical significance; 8. Patients with serious diseases in respiratory system and urinary system; 9. Patients who have received solid organ transplantation or corneal transplantation or bone marrow transplantation, or are planned to receive organ transplantation during this clinical study; 10. Patients with diabetes (glycosylated hemoglobin>7.0%) not controlled well or diseases in other endocrine system; 11. Patients with serious hematological system diseases or increased anemia (such as thalassemia, sickle cell anemia, spherocyte disease, gastrointestinal bleeding); 12. Patients with malignant tumor in medical history within 5 years before screening or patients who are suspected to have malignant tumor; 13. Patients with gastrointestinal disturbance or post-operation disease which may interfere with absorption of experimental drugs; 14. Patients who need to take the following drugs from the time of signing informed consent to termination of treatment: (1) CYP3A4 inducer (such as rifampicin and phenobarbital) and CYP3A inhibitor (such as voriconazole) of hepatic microsomal enzyme; (2) OATP inhibitor (such as cyclosporine and rifampicin) or substrate (such as rosuvastatin); (3) Drugs with narrow therapeutic window and substrates which allows CYP3A extensive metabolism and/or transfer of p glycoprotein (such as astemizole, ergometrine, cisapride, pimozide, midazolam, triazolam, atorvastatin, lovastatin, simvastatin and fluticasone propionate); (4) Hormonal contraceptive; (5) Resinae drugs which integrates probenecid and bile acid; (6) Immunosuppressive drug; (7) Drugs with cytotoxic effect or chemotherapy drugs; (8) Antiarrhythmic drugs (such as amiodarone, bepridil, flecainide, propafenone and quinindium); (9) Corticosteroid drugs (except some drugs for local medication); (10) PDE5 inhibitor (such as sildenafil, tadalafil and vardenafil). 15. Patients who donate blood or lose more than 400ml blood within 2 months before base line; or patients who receive treatment of G-CSF/EPO/TPO within 6 months before base line or patients who receive blood transfusion treatment within 6 months before base line or patients who receive other treatments with curative effects in haematological index within 6 months before base line; 16. Female patients in gestation period, lactation period (except non-breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analyze changes in detected value of non-invasive liver fibrosis or liver hardness of patients with liver fibrosis in treatment of Ganlong capsule in 48 weeks.;Evaluate changes in FIB-4 indexes of patients with liver fibrosis in treatment of Ganlong capsule in 48 weeks.;Analyze occurrence rate of liver cirrhosis of patients with liver fibrosis in treatment of Ganlong capsule in 48 weeks.; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Compare changes in detected value of non-invasive liver fibrosis or liver hardness of patients with liver fibrosis in treatment of Ganlong capsule in 12, 24 and 36 weeks.;2. Evaluate changes in FIB-4 indexes of patients with liver fibrosis in treatment of Ganlong capsule in 12, 24 and 36 weeks.;3. Analyze changes in count of T lymphocyte subpopulation of patients with liver fibrosis in treatment of Ganlong capsule in 12, 24, 36 and 48 weeks.; | — |
Contacts
Public ContactWEI JIA
The 2nd People's Hospital Yunnan Province
Outcome results
None listed