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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
| Fujian Cosunter Pharmaceutical Co. Ltd | INDUSTRY |
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The purpose of the study is to evaluate the effects and safety of Adefovir Dipivoxil plus polyene phosphatidylcholine compared to Adefovir Dipivoxil alone in patients with chronic hepatitis B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adefovir Dipivoxil and polyene phosphatidylcholine | Experimental | Adefovir Dipivoxil 10 mg once daily for 48 weeks plus Polyene phosphatidylcholine (PPC) 456 mg three times per day for 48 weeks |
|
| Adefovire Dipivoxil | Active Comparator | Adefovir Dipivoxil 10 mg once daily for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adefovir Dipivoxil and polyene phosphatidylcholine | Drug | Adefovir Dipivoxil 10 mg once daily for 48 weeks plus Polyene phosphatidylcholine (PPC) 456 mg three times per day for 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportions of subjects with histological response in treatment and control group. | at week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportions of subjects in each group who achieve: HBV DNA < 300 copies/mL | at week 48 | |
| Mean log10 reduction from baseline in HBVDNA | at week 12, 24, 48 | |
| ALT normalization rate and range |
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Inclusion Criteria:
Exclusion Criteria:
Received any nucleoside, nucleotide or interferon therapy within 6 months prior to the screening.
Previous treatment with lamivudine, adefovir, entecavir or telbivudine and occurred viral breakthrough or genotype resistance.
Received immunosuppressive agents or other immunoregulates (including thymosin),systemic cytotoxic drugs, other antiviral agents including Chinese herb medicine within 6 months prior to the screening.
Active alcohol intake( more than 20g/d for female or more than 30g/d for male) or drug abuse within 1 year prior to screening. Alcohol or drug abuse considered by the investigator to be sufficient to hinder compliance with treatment, participation in the study or interpretation of results.
ALT is greater than 10 times ULN at screening or has the history of transient decompensated liver disease due to acute exacerbation.
Any of the laboratory test at screening as the following :
Patient is coinfected with HCV, HDV or HIV.
Hepatocellular carcinoma (HCC), or the presence of a mass on imaging studies of the liver that is suggest of HCC, or an alpha-fetoprotein (AFP)> 500ng/mL.
Decompensated liver disease as defined by serum bilirubin >3mg/dL, prothrombin time≥ 4 seconds prolonged, a serum albumin<32g/L, or a history of ascites, variceal bleeding or hepatic encephalopathy.
Presence of other causes of liver disease (i.e.alcoholic liver disease,autoimmune hepatitis, hemochromatosis, Wilson disease, nonalcoholic steatohepatitis, alpha-1anti-trypsin deficiency).
Any serious or active medical or psychiatric illnesses other than hepatitis B which, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol. This would include, may not limit to, renal, cardiac, pulmonary, vascular, neurogenic, digestive, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders, active infection or cancer.
BMI≥30.
Patient is pregnant or breast-feeding.
Planned for liver transplantation or previous liver transplantation.
Need take hepatotoxic drugs (e.g.,dapsone, erythromycin, fluconazole, rifampin, etc) and nephrotoxic drugs (e.g., NSAIDs, aminoglycosides, amphotericin B, foscarnet, etc.) for long time.
History of hypersensitivity to nucleoside analogues.
Previous (or planned) participation in an investigational trial involving administration of investigational compound within 12 weeks prior to the study screening.
Poor compliance of the patient considered by investigator.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital, Capital Medical University | Beijing | 100015 | China |
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| Adefovir Dipivoxil | Drug | Adefovir Dipivoxil 10 mg once daily for 48 weeks |
|
| at week 12 and 48 |
| Liver stiffness values reduction from baseline by Fibroscan | at week 48 |
| HBeAg loss and HBe seroconversion | at week 12 and 48 |
| HBsAg loss and HBs seroconversion | at week 12 and 48 |
| Improvement in symptoms score | at week 12, 24 and 48 |
| Frequency of adverse events | up to 60 weeks |
| Frequency of serious adverse events | up to 60 weeks |
| Frequency of discontinuations from study drug due to adverse events or laboratory abnormalities. | up to 60 weeks |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C106812 | adefovir dipivoxil |
| C029449 | polyene phosphatidylcholine |
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