Chronic hepatitis C
Conditions
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The following criteria must be all met: 1. Have signed informed consent form (1) Patient must be informed and consent prior to study, and sign a written informed consent form voluntarily, including the screening procedure to judge if eligible; (2) Patient is able to well communicate with investigators and complete the study in compliance with the protocol. 2. Target population Treatment-Nave Subjects with liver function compensation chronic genotype 1 HCV infection, relevant standards are as follows: (1) Subjects who have never received any marketed or ongoing clinical studies drugs for anti-HCV treatment, included but not limited to interferon, ribavirin, Boceprevir, Telaprevir, Simeprevir, Sofosbuvir, Daclatasvir, Asunaprevir; (2) Subjects who have not received antiviral treatment within 6 months prior to screening, including traditional Chinese medicine, immunomodulators, thymosins or other immune-stimulating factors; (3) HCV RNA >=1*10^5 IU/mL (Roche COBAS Taqman) during screening; (4) Infection with chronic genotype 1 HCV infection as determined at Screening; (5) a positive HCV RNA or positive anti-HCV antibody test at least 6 months prior to screening, or a liver biopsy evidence of chronic HCV infection; (6) Fibroscan with a result of 50 years of age with cessation (for >=12 months of previously occurring menses); 2) Of childbearing potential (Women<50 years of age with amenorrhea will be considered to be of childbearing potential). These women must both have negative serum pregnancy test at screening and Baseline/Day 1 visit, and agree to take effective contraceptive measures from screening to 3 months after the last dose of investigational drugs, such as complete abstinence from intercourse, condom, intrauterine device, etc. 3) Male subject must agree to take effective contraceptive measures with his female partner from screening to 3 months after the last dose of investigational drugs (except of surgical sterilization), such as complete abstinence from intercourse, condom, female partner use intrauterine device, etc. 4) BMI is in 18?28 kg/m2, BMI= weight (kg) / height2 (m2).
Exclusion criteria
Exclusion criteria: Excluded if any of the following condition is met: 1. Gender and Fertility (1)Subjects who have taken long-term estrogen or progesterone injections or implant tablets within 1 months before administration of investigational drugs; (2) Women of child-bearing potential don't take appropriate contraception measures within 2 weeks prior to administration of investigational drugs; (3) Women who are on gestation period, lactation or planning to get pregnant in 3 months after the last dose of investigational drugs; (4) Women who have the positive result of pregnancy test from screening to pre-dose. 2. Physical and laboratory examination (1) Blood platelet count 2*ULN; (6) Albumin ULN; (8)INR>1.5; (9) AFP(alpha fetal protein) >50 ng/mL; (10) QTc>430 ms for males and >450 ms for females on screening or baseline (QTc calculated by Bazett correction formula: QTc=QT/RR0.5); (11) Thyroid Function TSH, T3, T4 showing abnormity and have clinical significance; (l2) CLcr (creatinine clearance rate) 1.5*ULN; (14) Other abnormal examination values are judged clinical significance by investigator. 3. Forbidden treatment and/or drug (1) Have taken any drug inhibiting gastric acid secretion within 1 month prior to dosing of investigational product, such as: H2 receptor antagonists including Cimetidine, Ranitidine, Famotidine, Nizatidine and Roxatidine; Proton pump inhibitors including Omeprazole, Lansoprazole, Rabeprazole, Pantoprazole and Esomeprazole; cholinoceptor blocking drugs including Atropine and Pirenzepine; (2) Have taken any gastric antacids within 1 month prior to dosing of investigational product, such as: Sodium bicarbonate, Magnesium hydrate, Aluminium hydroxide, Calcium carbonate and Magnesium trisilicate, etc.; (3) Have taken any drugs that can inhibit or induce hepatic metabolism within 1 month before administration of investigational drugs, such as: 1) Inducers-Barbitals, Glutethimide, Rifampicin, Carbamazepine, Phenytoin, Griseofulvin, Meprobamate, etc.; 2) Inhibitors-Macrolide antibiotics (e.g. Erythromycin, Clarithromycin), Azole antifungals (e.g. Ketoconazole, Itraconazole), Fluoroquinolones (e.g. Ciprofloxacin), Calcium channel antagonists (e.g. Verapamil, Diltiazem), H1 receptor antagonist (e.g. Astemizole), SSRI antidepressants (e.g. Fluoxetine, Fluvoxamine), Benzodiazepine tranquillizers, HMG-CoA reductase inhibitors (e.g. Lovastatin, Simvastatin), Nitroimidazoles, herbal drugs (e.g. Schisandra chinensis, Forsythia suspensa), etc.; (4) Have taken any prokinetic drugs within 1 month prior to dosing of investigational product, such as Metoclopramide, Domperidone, Cisapride, Mosapride, and so on; (5) Have taken drugs which need long-term use, and thereby causing immunosuppression, or having high risks of nephrotoxicity or hepatotoxicity, or affecting liver excretion, such as immunosuppressive drugs-systemic prednisone, mycophenolate mofetil, cyclosporine and antimetabolites (e.g. azathioprine); nephrotoxic drugs—amphotericin B, aminoglycosides, Foscarnet; hepatotoxic drugs-isoniazide; 4. Disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HCV RNA average level and average decline value compared with baseline from each time with each dosage; | — |
Countries
China
Contacts
Public ContactRowling Luo
Outcome results
None listed