Chronic Hepatitis BNCT00715715
Efficacy Study of Prednisone Priming to Treat Asian Chronic Hepatitis B Patients
A study testing Prednisone Priming in people with Chronic Hepatitis B, run by Maimonides Medical Center at 1 site in United States.
Trial summary
Patients with chronic hepatitis B constantly produce the virus in the body. The disease of chronic hepatitis B is the body responding to the virus. Use of steroids can adjust this response. After taking steroids, viral production usually increases and liver function tests increase. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Prednisone Priming
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Feb 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- This study is seeking patients with the following:
- Asians older than 16 years of age
- HBeAg-positive chronic hepatitis B, and
- Good liver function
- Positive hepatitis B surface antigen (HBsAg) for at least 24 weeks before screening
- Liver biopsy in the past year showing of chronic hepatitis
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- Blood testing showing HBV DNA in the past 4 weeks before screening
- Blood test showing high HBV DNA level (at least 20,000 IU/mL); AND
- Liver function test showing high serum ALT level (1.0 to 5.0 times the upper limit of normal).
Who cannot join
- Ongoing drug abuse
- Active alcoholism
- Coinfection with hepatitis C, hepatitis D, or HIV
- Presence of other forms of liver disease
- Use of interferon alfa, thymosin, or antiviral agents with activity against hepatitis B within 24 weeks before randomization
- Prior lamivudine therapy lasting more than 12 weeks
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- Previous treatment with Adefovir dipivoxil
- AFP level greater than 100 ng/mL
- Decompensated liver disease
- History of ascites requiring diuretics or paracentesis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Adefovir Dipivoxil Alone and After Prednisone Priming for the Treatment of Asian Patients With HBeAg-positive Chronic Hepatitis B
Patients with chronic hepatitis B constantly produce the virus in the body. The disease of chronic hepatitis B is the body responding to the virus. Use of steroids can adjust this response. After taking steroids, viral production usually increases and liver function tests increase. After stopping steroids, viral production usually decreases. Many studies in the past have studied taking a low dose steroid before treating hepatitis B. Those studies have shown that low dose steroids help your body to clear the virus. The goal of this study is to improve the liver function by slowing viral growth.
Read the detailed description
Asian patients who are older than 16 years of age and have HBeAg-positive chronic hepatitis B and good liver function will be entered in this study. Qualified patients also have positive hepatitis B surface antigen (HBsAg) for at least 24 weeks before screening, evidence of chronic hepatitis on a baseline liver-biopsy sample obtained within 52 weeks before entry, evidence of HBV DNA by any commercial tests at least 4 weeks before screening, an high HBV DNA level (at least 20,000 IU/mL) at screening, and a high serum ALT level (1.0 to 5.0 times the upper limit of normal) at screening.
This study involves experimental use of an approved drug (Prednisolone) on chronic hepatitis B patients. Patients will be involved in the study for up to 96 weeks from enrollment. There is no external sponsor, commercial sponsor nor federal agency on this study. The study will be conducted only at Maimonides Medical Center, its GI clinic and faculty practice. About 40 subjects will be involved in the study overall. All the subjects will be filled up locally.
- Conditions
- Chronic Hepatitis B
- Being tested
- Prednisone Priming
- Keywords
- Hepatitis B e Antigen, HBeAg-positive chronic hepatitis B
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisone PrimingDrug
For randomly selected patients treated with steroids: The patients will receive prednisone 30 mg daily for 3 weeks, 15 mg daily for 1 week, no treatment for 2 weeks, followed by Adefovir dipivoxil (Hepsera) 10 mg daily for a minimum of 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Patients that meet the requirements listed above will be selected sequentially. Blood tests, including liver function tests and hepatitis profiles will be taken. A liver biopsy will be done before the treatment to evaluate the severity of hepatitis. For randomly selected patients not treated with steroids: The patients will receive 6 weeks of sugar pills (placebo) before taking Adefovir dipivoxil (Hepsera) 10 mg daily for a minimum of 52 weeks. All patients will get another liver biopsy at week 48 to evaluate the improvement of liver inflammation after their treatment. Blood tests will be drawn in accordance with the standard treatment. Generally speaking, hospitalization is not required for this study. |
| 2 | Experimental | Patients that meet the requirements listed above will be selected sequentially. Blood tests, including liver function tests and hepatitis profiles will be taken. A liver biopsy will be done before the treatment to evaluate the severity of hepatitis.
For randomly selected patients treated with steroids: The patients will receive prednisone 30 mg daily for 3 weeks, 15 mg daily for 1 week, no treatment for 2 weeks, followed by Adefovir dipivoxil (Hepsera) 10 mg daily for a minimum of 52 weeks.
All patients will get another liver biopsy at week 48 to evaluate the improvement of liver inflammation after their treatment. Blood tests will be drawn in accordance with the standard treatment. Generally speaking, hospitalization is not required for this study. Receives: Drug: Prednisone Priming |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy end points at week 48 include the reduction in HBV DNA, HBeAg seroconversion, normalization of ALT.
Measured: week 48
Secondary outcomes (1)
Secondary efficacy end point is the proportion of patients with histologic improvement.
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startApr 2008
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: Withdrawn studies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimonides Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting-Hui Hsieh, Maimonides Medical Center
- Investigators
- Jianjun Li, MD, Principal investigator, Maimonides Medical CenterTing-Hui Hsieh, MD, Principal investigator, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715715
- Sponsor's protocol ID
- 08-01-IVA6
- Status last verified
- Apr 2012
- First submitted
- 11 Jul 2008
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Adefovir Dipivoxil Alone and After Prednisone Priming for the Treatment of Asian Patients With HBeAg-positive Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT00715715
- Acronym / sponsor ID
- 08-01-IVA6
- Conditions
- Chronic Hepatitis B
- Keywords
- Hepatitis B e Antigen, HBeAg-positive chronic hepatitis B
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn studies.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maimonides Medical CenterUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 15 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with chronic hepatitis B constantly produce the virus in the body. The disease of chronic hepatitis B is the body responding to the virus. Use of steroids can adjust this response. After taking steroids, viral production usually increases and liver function tests increase. After stopping steroids, viral production usually decreases. Many studies in the past have studied taking a low dose steroid before treating hepatitis B. Those studies have shown that low dose steroids help your body to clear the virus. The goal of this study is to improve the liver function by slowing viral growth.
Detailed description
Asian patients who are older than 16 years of age and have HBeAg-positive chronic hepatitis B and good liver function will be entered in this study. Qualified patients also have positive hepatitis B surface antigen (HBsAg) for at least 24 weeks before screening, evidence of chronic hepatitis on a baseline liver-biopsy sample obtained within 52 weeks before entry, evidence of HBV DNA by any commercial tests at least 4 weeks before screening, an high HBV DNA level (at least 20,000 IU/mL) at screening, and a high serum ALT level (1.0 to 5.0 times the upper limit of normal) at screening.
This study involves experimental use of an approved drug (Prednisolone) on chronic hepatitis B patients. Patients will be involved in the study for up to 96 weeks from enrollment. There is no external sponsor, commercial sponsor nor federal agency on this study. The study will be conducted only at Maimonides Medical Center, its GI clinic and faculty practice. About 40 subjects will be involved in the study overall. All the subjects will be filled up locally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Patients that meet the requirements listed above will be selected sequentially. Blood tests, including liver function tests and hepatitis profiles will be taken. A liver biopsy will be done before the treatment to evaluate the severity of hepatitis. For randomly selected patients not treated with steroids: The patients will receive 6 weeks of sugar pills (placebo) before taking Adefovir dipivoxil (Hepsera) 10 mg daily for a minimum of 52 weeks. All patients will get another liver biopsy at week 48 to evaluate the improvement of liver inflammation after their treatment. Blood tests will be drawn in accordance with the standard treatment. Generally speaking, hospitalization is not required for this study. |
| 2 | Experimental | Drug: Prednisone PrimingPatients that meet the requirements listed above will be selected sequentially. Blood tests, including liver function tests and hepatitis profiles will be taken. A liver biopsy will be done before the treatment to evaluate the severity of hepatitis. For randomly selected patients treated with steroids: The patients will receive prednisone 30 mg daily for 3 weeks, 15 mg daily for 1 week, no treatment for 2 weeks, followed by Adefovir dipivoxil (Hepsera) 10 mg daily for a minimum of 52 weeks. All patients will get another liver biopsy at week 48 to evaluate the improvement of liver inflammation after their treatment. Blood tests will be drawn in accordance with the standard treatment. Generally speaking, hospitalization is not required for this study. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Asians older than 16 years of age
- HBeAg-positive chronic hepatitis B, and
- Good liver function
- Positive hepatitis B surface antigen (HBsAg) for at least 24 weeks before screening
- Liver biopsy in the past year showing of chronic hepatitis
Key exclusion criteria (10 listed)
- Ongoing drug abuse
- Active alcoholism
- Coinfection with hepatitis C, hepatitis D, or HIV
- Presence of other forms of liver disease
- Use of interferon alfa, thymosin, or antiviral agents with activity against hepatitis B within 24 weeks before randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisone PrimingFor randomly selected patients treated with steroids: The patients will receive prednisone 30 mg daily for 3 weeks, 15 mg daily for 1 week, no treatment for 2 weeks, followed by Adefovir dipivoxil (Hepsera) 10 mg daily for a minimum of 52 weeks. | Drug | 2 |
Primary outcome
The primary efficacy end points at week 48 include the reduction in HBV DNA, HBeAg seroconversion, normalization of ALT.
Time frame: week 48
1 secondary outcome
Secondary efficacy end point is the proportion of patients with histologic improvement.
Time frame: Week 48
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianjun Li, MD principal investigator
Maimonides Medical Center
Ting-Hui Hsieh, MD principal investigator
Maimonides Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prednisone Priming in people with Chronic Hepatitis B, run by Maimonides Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy end points at week 48 include the reduction in HBV DNA, HBeAg seroconversion, normalization of ALT. (time frame: week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2012.