Antiviral Treatment of Chronic Hepatitis B Clinical Trial
Patients with spontaneous decline of HBV DNA were non-randomly assigned to accept peginterferon alfa-2a or entecavir therapy, or didn't accept any antiviral regiment.
| Status | Completed |
| Enrollment | 74 |
| Est. completion date | February 2013 |
| Est. primary completion date | November 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 16 Years to 60 Years |
| Eligibility |
This study focused on the subsequential antiviral therapeutic strategies for chronic
hepatitis B patients with spontaneous decline of HBV DNA after acute exacerbation.
Patients fullfilled the following criterias were chosen for screening: They were antiviral
treatment nai¨ve and had been positive for hepatitis B surface antigen (HBsAg) for at
least 6 months, were positive for HBeAg and had an HBV DNA Level of more than
500,000IU/ml. Their serum alanine aminotransferase level was greater than 2 but less than
or equal to 30 times the upper limit of the normal range, their peak value of total
bililubin ranged from 2mg/ml to 20mg/ml and the prothrombin time activity was greater than
60%. ALL of these patients were hospitalized and pretreated with anti-inflammation and liver protection agents such as Stronger Neo-Minophagen C, Polyunsaturated phosphatidylcholine (Essentiale), Ursodeoxycholic Acid and L-Glutathione reduced, without any nuclutide of nucleoside. Their ALT?TBIL and PTA were monitor weekly and HBVDNA level were measured every two weeks. Patients were eligible if their HBVDNA declined spontaneously by 2 log(10) IU/mL while their ALT falled below 10 ULN and TBIL falled below 2mg/ml within 8 weeks of pretreatment. Patients with advanced fibrosis, cirrhosis and hepatoma were excluded. Other cause of chronic liver disease should be systematically checked to exclude co-infection with HDV, HCV and HIV, comorbidities with alcoholism, autoimmune and metabolic liver disease. Serious medical or psychiatric illnesses that had usage of corticosteroid or immunosup-pressive agents at the time of study were excluded. All patients in this study lived in Guangdong, a province of 100,000,000 populations, with same demographics. Owing to patients fear or refusal of liver biopsy, no patients had the liver biopsy and the rest relied on other clinical methods to obtain equivalent information of patient conditions. In our cases, ultrasonorgraphy helped to filter out patients with advanced fibrosis.The liver sonar examination was performed by two experi-enced hepatologists at least three times on each patient. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Third Affiliated Hospital, Sun Yat-Sen University |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Complete viralogic response | Complete viralogic response was defined as suppression of HBV DNA to the level below 60IU/mL(detected by Cobas Amplicor HBV Monitor Test, Roche Diagnostics). | week 96 | Yes |
| Secondary | HBsAg loss and seroconversion | HBsAg loss was defined as HBsAg titre less than 0.05 IU/mL and the HBsAg seroconversion was defined as the loss of HBsAg and the presence of anti-HBs antibody. HBeAg seroconversion was defined as disappearance of HBeAg and appearance of anti-HBe antibody, while HBeAg loss was defined as disappearance of HBeAg only. | week 24,48,72 and 96 | No |
| Secondary | ALT normalization | ALT normalization was defined as ALT level less than 40 IU/L(determined by a sequential multiple autoanalyzer). | week 24,48,72 and 96 | No |
| Secondary | Sick leave in patients in different groups | week 48,72 and 96 | Yes |