Chronic Hepatitis B e Antigen Negative Clinical Trial
Official title:
Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir DF Versus Tenofovir DF Monotherapy in HBeAg-Positive and HBeAg-Negative Chronic Hepatitis B
Background:
- There are two forms of chronic hepatitis B. The difference between the forms is whether or
not a viral protein called hepatitis B e antigen is present in the blood. Standard
approaches to treating both forms of chronic hepatitis B involve different drugs. One drug
is called peginterferon, another is called tenofovir DF. These drugs are often given
separately and used for different forms of the disease. However, researchers want to see if
combining peginterferon and tenofovir DF will be a more effective treatment than tenofovir
DF alone.
Objectives:
- To see whether combining tenofovir DF and peginterferon, or using tenofovir DF alone, is a
more effective treatment of chronic hepatitis B.
Eligibility:
- Individuals at least 18 years of age who have chronic hepatitis B and are in the Hepatitis
B Research Network Cohort study.
Design:
- Participants will be screened with a physical exam and medical history. Blood, urine,
and liver tissue samples will be collected. Bone and liver imaging studies will also be
performed.
- Participants will be divided into two groups. One group will have tenofovir DF alone
for 192 weeks (about 4 years). The other group will have tenofovir DF and peginterferon
for 24 weeks (about 6 months), and then tenofovir DF alone for 168 weeks (about 3.5
years).
- Participants will take the study drugs on the schedule determined by their study
doctors. They will keep a diary to record their doses and any side effects.
- Participants will have three study visits 4 weeks apart after the starting the
treatment. At these visits, they will have a physical exam and provide blood samples.
They may also provide urine samples and have imaging studies.
- After the first three study visits, participants will continue to have study visits
every 12 weeks until the treatment ends at week 192. These visits will have many of the
same tests as the first three visits. At some of these visits, they may fill out
questionnaires about their quality of life.
- Participants who do not respond to the study drugs may have their medications changed.
They may also be asked to stop treatment.
This is a randomized (1:1) parallel group design trial comparing (i) tenofovir DF 300 mg daily for 192 weeks (4 years) and (ii) peginterferon alfa-2a 180 micrograms/g weekly for 24 weeks plus tenofovir DF 300 mg daily for 192 weeks (4 years). Enrolled participants will be stratified by HBeAg status (positive/negative), genotype (A vs. all others) and cirrhosis (present vs. absent). After 192 weeks of treatment, participants meeting criteria for treatment discontinuation will stop treatment and be followed for 48 weeks (total duration of treatment and follow up is 240 weeks). A liver biopsy will be obtained at the end-of treatment (week 180-192) to assess improvement in histology. Emtricitabine/tenofovir coformulated as Truvada, approved for treating HIV but not for treating HBV infection, will be offered to participants with primary nonresponse, partial virological response or confirmed virologic breakthrough. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01581554 -
Withdrawal of Therapy After Long-Term Antiviral Treatment for Chronic Hepatitis B
|
||
| Recruiting |
NCT01306071 -
Observational Study of Persons With Hepatitis B Virus Infection in North America
|
N/A |