Chronic Heptitis B Clinical Trial
| Verified date | July 2017 |
| Source | Chinese University of Hong Kong |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Currently, five nucleos(t)ide analogs are approved for the treatment of chronic hepatitis B,
namely lamivudine, adefovir dipivoxil, telbivudine, entecavir (ETV) and tenofovir disoproxil
fumarate (TDF). ETV and TDF are recommended as first-line therapy by all regional guidelines
due to their high anti-viral potency and low risk of inducing resistance.
ETV monotherapy for chronic HBV infection is highly effective in both HBeAg-positive and
negative treatment-naïve patients. The cumulative probability of maintained virologic
suppression with undetectable HBV DNA at year 1, 2 and 3 were 76.5%, 83.0% and 88.3%
respectively.
TDF is another potent anti-viral treatment for chronic hepatitis B. Up to 72% and 87% of
HBeAg-positive and -negative patients achieved undetectable HBV DNA by week 144 of TDF
monotherapy. It is also effective in patients with prior exposure to other nucleo(s)tide
analogs. Previous studies demonstrated that TDF can be used as an effective rescue therapy in
lamivudine or adefovir-treated patients with incomplete virologic response.
However, the optimal treatment for patients with suboptimal response to ETV is uncertain.
With this background, we will conduct a randomized controlled trial to evaluate the efficacy
of TDF switch therapy in patients with incomplete virologic response to ETV treatment.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | January 31, 2017 |
| Est. primary completion date | January 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Age 18 or above - Positive hepatitis B surface antigen for at least 6 months - On ETV monotherapy as anti-viral treatment for at least 52 weeks - HBV DNA (>20 IU/ml) at week 52 or more of ETV treatment - Written informed consent obtained Exclusion Criteria: - Concurrent use of other antiviral treatment (including oral nucleos(t)ide analogs, interferon or pegylated interferon) for chronic hepatitis B. - Concurrent use of steroids or immunosuppressive agents more than two week consecutively - Co-infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV). - Features suggestive of concomitant chronic liver diseases: positive anti-nuclear antibody (ANA) titer above 1/160, positive anti-mitochondrial antibody (AMA), anti-smooth muscle antibody (SMA), abnormal serum ceruloplasmin or iron profile, or histological features of alternative chronic liver disease - Pregnancy or breast feeding. - Inability or unwillingness to give informed consent or abide by the requirements of the study. - History of other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study. - Patients with baseline significant impaired renal function with creatinine clearance <30 ml/min or receiving dialysis for end stage renal disease. |
| Country | Name | City | State |
|---|---|---|---|
| Hong Kong | Prince of Wales Hospital | Hong Kong |
| Lead Sponsor | Collaborator |
|---|---|
| Chinese University of Hong Kong |
Hong Kong,
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* Note: There are 18 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maintained virologic response | Undetectable HBV DNA by PCR assay | 48 weeks | |
| Secondary | Undetectable HBV DNA at week 24 and 48 | At week 24 and 48 | ||
| Secondary | Amino acid substitutions or drug resistance | At week 48 | ||
| Secondary | Normal ALT, RFT and bone profile | At week 24 and 48 | ||
| Secondary | Numbers of adverse events or serious adverse events | An adverse event is any undesirable medical event occurring in the subject within the trial period, whether or not it is related to the study drug. A serious adverse event is an adverse event that results in one of the following outcomes: Death Life-threatening In-patient hospitalization or prolongation of existing hospitalization A persistent or significant disability/incapacity |
At week 48 |