chronic hepatitis B
Conditions
Interventions
120mgGLS4/100mgRTV:120mgGLS4/100mgRTV, QD
240mgGLS4/100mgRTV:240mgGLS4/100mgRTV, QD
0.5mgETV:0.5mgETV, QD
Sponsors
Jilin University First Hosptal
Eligibility
Sex/Gender
All
Inclusion criteria
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. Infection history of chronic hepatitis B virus with compensated liver function, relevant standards are as follows: 1) Positive HBsAg, positive HBeAg, negative anti-HBcIgM or Positive HBsAg, positive HBeAg, a liver biopsy performed prior to the Baseline/Day 1 visit with evidence of chronic HBV infection, in the case of liver biopsy results, the liver biopsy results shall prevail; 2) Treatment-Naveor. Subjects received treatment with IFN/Peg-IFN, or anti-HBV nucleoside drugs (Lamivudine, Telbivudine, Entecavir, Adefovir dipivoxil, or Tenofovir Disoproxil), and discontinued treatment at least 3 months prior to the screening; 3) Subjects who have not received antiviral treatment within 6 months prior to screening, including traditional Chinese medicine, immunomodulators, thymosins or other immune-stimulating factors; 4) HBV DNA >=1/105 IU/mL(PCR)during screening; 5) serum ALT 1.3 to 10×ULN; 6) Fibroscan with a result of 50 years of age with cessation (for >=12 months of previously occurring menses); or (2) Of childbearing potential (Women<=50 years of age with amenorrhea will be considered to be of childbearing potential). These women must have negative urine pregnancy test at screening, 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 screening; (2) Women of child-bearing potential dont take appropriate contraception measures within 2 weeks prior to screening; (3) Women who are on gestation period, lactation or planning to get pregnant within 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; (5) Albumin 1.5; (8) AFP(alpha fetal protein) >50 ng/mL; (9) Screening ECG with clinically significant abnormalities, QTc>450 ms (QTc calculated by Fridericia correction formula: QTc=QT/RR0.33); (10) Thyroid Function TSH, FT3, FT4 showing abnormity and have clinical significance; (11) Other abnormal examination values are judged clinical significance by investigator (except of parameters associated with progress of chronic hepatitis B, such as ALT, AST, GGT, bilirubin, HBV serology, liver biopsy results, etc); 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) InducersBarbitals, Glutethimide, Rifampicin, Carbamazepine, Phenytoin, Griseofulvin, Meprobamate, etc; 2) InhibitorsMacrolide 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 kidney excretion, such as immunosuppressive drugssystemic prednisone, mycophenolate mofetil, cyclosporine and antimetabolites (e.g. azathioprine); nephrotoxic drugsamphotericin B, aminoglycosides, Foscarnet; hepatotoxic drugsisoniazide; (6) Have taken other drugs which would affect pharmacokinetics of investigational product or investigational product would affect its pharmacokinetics before screening, and administration time prior to the screening is <10×t1/2 of the dru
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic profile;safety;HBV DNA average level and average decline value compared with baseline from each time with each dosage; | — |
Secondary
| Measure | Time frame |
|---|---|
| average concentration of serum HBsAg and HBeAg with different detection time of each group;Improvement of ALT levels; | — |
Countries
China
Contacts
Public ContactWang Zhaohe
sunshine lake pharma co., ltd.
Outcome results
None listed