HBV (Hepatitis B Virus)Phase 2NCT00023309
Lamivudine and Adefovir to Treat Chronic Hepatitis B
A Phase 2 study testing Lamivudine and adefovir and Adefovir alone in people with HBV (Hepatitis B Virus) and Hepatitis B, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
This study will evaluate the safety and effectiveness of lamivudine plus adefovir versus adefovir alone to treat chronic hepatitis B infection. The Food and Drug Administration has approved lamivudine for the treatment of hepatitis B. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HBV (Hepatitis B Virus), Hepatitis B, Hepatitis
- What is being tested?
- Lamivudine and adefovir and Adefovir alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Aug 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years and above, male or female
- Known serum HBsAg positivity for at least 6 months
- Detectable HBV-DNA in serum above 1 million copies per ml, as detected by quantitative PCR (Roche Cobas Assay)
- Serum ALT (alanine aminotransferase) or AST (aspartate aminotransferase)levels above the upper limit of normal based on two determinations taken at least one month apart during the 6 months before entry
- Liver biopsy within 2 years consistent with chronic hepatitis and with a histology activity index score (HAI) of 6 or more (out of a total possible score of 22) and an "Ishak" fibrosis score of at least 1 (out of a total possible score of 6). For patients with lamivudine resistance the liver biopsy may be performed either on or off lamivudine.
- Written informed consent.
Who cannot join
- Previous or current treatment with adefovir or tenofovir.
- Co-infection with HDV (Hepatitis D Virus) as defined by the presence of both anti-HDV in serum and HDV antigen in liver
- Co-infection with HCV (Hepatitis C Virus) as defined by the presence of both anti-HCV and HCV RNA in serum.
- Co-infection with HIV (Human immunodeficiency virus) as defined by the presence of anti-HIV in serum.
- Decompensated liver disease as defined by serum bilirubin greater than 2.5 mg%, prothrombin time of greater than 2 seconds prolonged, a serum albumin of less than 3.0 gm%, or a history of ascites, variceal bleeding, or hepatic encephalopathy.
- Presence of other causes of liver disease (i.e., hemochromatosis, Wilson's disease, alcoholic liver disease, non-alcoholic steatohepatitis, alpha-1 antitrypsin deficiency)
Show all 20Show fewer
- A history of organ transplantation or in the absence of organ transplantation, any immunosuppressive therapy requiring the use of more than 5 mg of prednisone (or its equivalent) daily.
- Significant systemic illnesses other than liver diseases including congestive heart failure, renal failure, chronic pancreatitis, diabetes mellitus with poor control that in the opinion of the investigators might interfere with therapy.
- Pregnancy or inability to practice contraception in patients capable of bearing or fathering children
- Pre-existing bone marrow suppression: White Blood Cells (WBC) less than 2,000 cells/mm(3), hematocrit less than 30%, or platelets less than 50,000 cells/mm(3).
- History of clinically apparent pancreatitis or evidence of subclinical pancreatitis as shown by serum amylase values twice the upper limits of the normal range and abnormalities of the pancreas on CT or other imaging studies of the abdomen
- Prior interferon treatment within 6 months of entry
- Sensory or motor neuropathy apparent from medical history and physical examination
- Creatinine clearance less than 50 ml/min or serum creatinine greater than 1.5 mg/dl; creatinine clearance will be determined on a 24 hour urine specimen. Accuracy of collection will be ensured by documenting appropriate total creatinine excretion in the 24 hour urine specimen (15 mg/kg) and correcting for the patient's age and gender.
- Concurrent use of nephrotoxic agents (e.g., aminoglycosides, amphotericin B, vancomycin, foscarnet, cis-platinum, pentamidine, nonsteroidal anti-inflammatory agents) or competitors of renal tubular excretion (e.g., probenecid) within 2 months prior to study screening or the expectation that the subject will receive these during the course of the study
- History of hypersensitivity to nucleoside/nucleotide analogues
- Active ethanol/drug abuse/psychiatric problems that, in the investigator's opinion, might interfere with participation in the study
- History of seizure disorder
- History of renal tubular acidosis
- History of malignancy or treatment for a malignancy within the past 5 years
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Combination of Lamivudine and Adefovir Dipivoxil for Treatment of Chronic Hepatitis B
This study will evaluate the safety and effectiveness of lamivudine plus adefovir versus adefovir alone to treat chronic hepatitis B infection. The Food and Drug Administration has approved lamivudine for the treatment of hepatitis B. However, the drug is not effective in all patients, and many of those in whom it initially works develop resistance after 1 to 3 years. Adefovir is an experimental drug that inhibits replication of the hepatitis B virus (HBV). Adefovir used alone may be adequate to provide sustained suppression of the virus and improvement in liver disease. However combining two anti-viral agents may be superior to using one alone, similar to the strategy employed for the treatment of AIDS. This study will test whether the combination of lamivudine and adefovir is better than adefovir alone for the treatment of chronic hepatitis B.
Patients 18 years of age and older, who have been infected with HBV for at least 6 months, may be eligible for this study. Candidates may not have received lamivudine treatment in the past 6 months or prior treatment with adefovir and must not be taking other anti-viral treatments for their hepatitis. They will have a blood test to confirm HBV infection.
Read more
Participants will be admitted to the NIH Clinical Center for 2 to 3 days for a medical evaluation. One to 2 weeks after the evaluation, patients will be randomized to begin taking lamivudine and adefovir, or adefovir alone. Therapy will continue for at least 12 months. Follow-up clinic visits will be scheduled weekly for the first month, then every 4 to 8 weeks for the rest of the treatment period. Patients will be evaluated at the end of 1 year. Patients who have not improved with treatment will stop taking the treatment and will be evaluated in the clinic once every 4 weeks for another 6 months. Patients who show an improvement in their liver injury may continue taking lamivudine and adefovir or adefovir alone for 4 more years, as long as they continue to improve with the medication. Progress will be evaluated. If the test results show no continued improvement or are negative for hepatitis B antigens, therapy will be stopped.
Patients who continue treatment for 5 years will be readmitted at year 4 for another medical evaluation to assess the effects of treatment at that time. After the 5 years all patients will stop therapy at and be followed with regular clinic visits for at least 6 months.
Read the detailed description
Aims: To assess the safety, antiviral activity and clinical benefit of the combination of lamivudine and adefovir dipivoxil vs adefovir alone in up to 80 patients with chronic hepatitis B for up to five years.
Background: Adefovir dipivoxil and lamivudine are oral antiviral agents that have been shown to have potent activity against HBV in vitro and in vivo. Both drugs have been used extensively in patients with HIV infection and more recently in controlled trials as monotherapy in patients with chronic hepatitis B. Lamivudine is currently approved as therapy of hepatitis B and has been evaluated extensively both as a one-year course of treatment as well as long-term continuous therapy. While lamivudine monotherapy induces a transient improvement in viral levels and liver histology, viral resistance develops in a large proportion of patients with re-appearance of HBV DNA in serum in high levels associated with mutations in the Tyrosine-methionine-aspartate-aspartate (YMDD) motif of the HBV polymerase gene and worsening of the hepatitis. Adefovir monotherapy, in contrast, has not been shown to be associated with development of viral resistance even when given for up to two years. When given as monotherapy for 1 year, adefovir leads to improvement in histology of hepatitis B in approximately 50% of patients. At present, the long-term efficacy of adefovir has not been shown.
Protocol: Up to 80 patients with chronic hepatitis B who have raised serum ALT (alanine aminotransferase) levels, HBV DNA in serum (above 1 million copies per ml by quantitative PCR) and active liver disease on liver biopsy will be enrolled and started on the combination of lamivudine (100 mg daily) and adefovir dipivoxil (10 mg daily) or adefovir alone (10 mg daily). Patients will be stratified into one of four groups of 20 patients for randomization: (A) Lamivudine naive and HBeAg positive, (B) Lamivudine naive and HBeAg negative (C) previous lamivudine therapy and HBeAg positive and (D) previous lamivudine therapy and HBeAg negative. Patients will be monitored carefully during therapy for adverse events, clinical symptoms and signs of liver disease, biochemical, and hematological parameters, and HBV serology at 2 to 4 week intervals. The primary endpoint of therapy will be a maintained combined response (a combination of virological, biochemical, and histological response) with major timing of end-points being at 1 and 4 years. Secondary endpoints will include loss of HBeAg, the individual types of maintained responses (virological, biochemical and histological), the development of lamivudine resistance, and improvement in symptom scores and quality of life assessments at 1 and 4 years.
Conclusions: This study will assess the effects of the combination of lamivudine and adefovir dipivoxil compared to adefovir alone in suppressing hepatitis B and prevention of lamivudine resistant mutants that arise during long-term therapy with lamivudine alone.
- Conditions
- HBV (Hepatitis B Virus), Hepatitis B, Hepatitis
- Being tested
- Lamivudine and adefovir, Adefovir alone
- Keywords
- Adefovir Dipivoxil, Lamivudine, Nucleoside/Nucleotide Analogue, Chronic Hepatitis B, Hepatitis B Mutants, Liver Biopsy, Hepatitis B, Hepatitis, HBV, Liver
- Medical subject headings
- Hepatitis B, Hepatitis, Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamivudine and adefovirDrug
Lamivudine (100 mg/day) and adefovir (10 mg/day)
Adefovir aloneDrug
Adefovir (10 mg/day)
| Study group | Role | What they receive |
|---|---|---|
| Lamivudine and adefovir | Experimental | Not described Receives: Drug: Lamivudine and adefovir |
| Adefovir | Active comparator | Not described Receives: Drug: Adefovir alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintained Combined Response (Virological, Biochemical and Histological Response).
A maintained combined response was defined as a combination of a virological, biochemical and histological responses at weeks 48 and 192. A virological response was defined as a decrease in HBV DNA levels to undetectable by the Amplicor assay (<500 copies/mL). A biochemical response was defined as a decrease in serum ALT levels into the normal range (<41 U/L). A histological response was defined as a decrease in the HAI score by at least three points with no worsening of the Ishak fibrosis score.
Measured: 196 weeks from randomization
Secondary outcomes (4)
HBeAg Loss at Week 196
Loss of hepatitis B surface antigen (HBsAg) at week 196
Measured: Week 196 from randomization
Virological Response
A virological response was defined as a decrease in HBV DNA levels to undetectable by the Amplicor assay (<500 copies/mL).
Measured: Week 196 from randomization
Biological Response
A biochemical response was defined as a decrease in serum ALT levels into the normal range (<41 U/L).
Measured: week 196 from randomization
Histological Response
A histological response was defined as a decrease in the HAI score by at least three points with no worsening of the Ishak fibrosis score.
Measured: week 196 from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2001 (estimated)
- Study startAug 2001
- Primary completionApr 2010
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HBV (Hepatitis B Virus)Studies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Marc Ghany, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Investigators
- Ghany Mark, MD, Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00023309
- Sponsor's protocol ID
- 010246
- Other IDs
- 01-DK-0246
- Status last verified
- Jul 2014
- First submitted
- 3 Sep 2001
- Last updated
- 23 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Niederau C, Heintges T, Lange S, Goldmann G, Niederau CM, Mohr L, Haussinger D. Long-term follow-up of HBeAg-positive patients treated with interferon alfa for chronic hepatitis B. N Engl J Med. 1996 May 30;334(22):1422-7. doi: 10.1056/NEJM199605303342202.
PubMed 8618580Malik AH, Lee WM. Chronic hepatitis B virus infection: treatment strategies for the next millennium. Ann Intern Med. 2000 May 2;132(9):723-31. doi: 10.7326/0003-4819-132-9-200005020-00007.
PubMed 10787366Hoofnagle JH, di Bisceglie AM. The treatment of chronic viral hepatitis. N Engl J Med. 1997 Jan 30;336(5):347-56. doi: 10.1056/NEJM199701303360507. No abstract available.
PubMed 9011789Ghany MG, Feld JJ, Zhao X, Heller T, Doo E, Rotman Y, Nagabhyru P, Koh C, Kleiner DE, Wright EC, Liang TJ, Hoofnagle JH. Randomised clinical trial: the benefit of combination therapy with adefovir and lamivudine for chronic hepatitis B. Aliment Pharmacol Ther. 2012 May;35(9):1027-35. doi: 10.1111/j.1365-2036.2012.05059.x. Epub 2012 Mar 26.
PubMed 22449251
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Lamivudine and Adefovir Dipivoxil for Treatment of Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT00023309
- Acronym / sponsor ID
- 010246
- Conditions
- HBV (Hepatitis B Virus), Hepatitis B, Hepatitis
- Keywords
- Adefovir Dipivoxil, Lamivudine, Nucleoside/Nucleotide Analogue, Chronic Hepatitis B, Hepatitis B Mutants, Liver Biopsy, Hepatitis B, Hepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Aug 2001
- Primary completion
- Apr 2010 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 3 Sep 2001 (estimated)
- Results
- Posted 4 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and effectiveness of lamivudine plus adefovir versus adefovir alone to treat chronic hepatitis B infection. The Food and Drug Administration has approved lamivudine for the treatment of hepatitis B. However, the drug is not effective in all patients, and many of those in whom it initially works develop resistance after 1 to 3 years. Adefovir is an experimental drug that inhibits replication of the hepatitis B virus (HBV). Adefovir used alone may be adequate to provide sustained suppression of the virus and improvement in liver disease. However combining two anti-viral agents may be superior to using one alone, similar to the strategy employed for the treatment of AIDS. This study will test whether the combination of lamivudine and adefovir is better than adefovir alone for the treatment of chronic hepatitis B.
Patients 18 years of age and older, who have been infected with HBV for at least 6 months, may be eligible for this study. Candidates may not have received lamivudine treatment in the past 6 months or prior treatment with adefovir and must not be taking other anti-viral treatments for their hepatitis. They will have a blood test to confirm HBV infection.
Participants will be admitted to the NIH Clinical Center for 2 to 3 days for a medical evaluation. One to 2 weeks after the evaluation, patients will be randomized to begin taking lamivudine and adefovir, or adefovir alone. Therapy will continue for at least 12 months. Follow-up clinic visits will be scheduled weekly for the first month, then every 4 to 8 weeks for the rest of the treatment period. Patients will be evaluated at the end of 1 year. Patients who have not improved with treatment will stop taking the treatment and will be evaluated in the clinic once every 4 weeks for another 6 months. Patients who show an improvement in their liver injury may continue taking lamivudine and adefovir or adefovir alone for 4 more years, as long as they continue to improve with the medication. Progress will be evaluated. If the test results show no continued improvement or are negative for hepatitis B antigens, therapy will be stopped.
Patients who continue treatment for 5 years will be readmitted at year 4 for another medical evaluation to assess the effects of treatment at that time. After the 5 years all patients will stop therapy at and be followed with regular clinic visits for at least 6 months.
Detailed description
Aims: To assess the safety, antiviral activity and clinical benefit of the combination of lamivudine and adefovir dipivoxil vs adefovir alone in up to 80 patients with chronic hepatitis B for up to five years.
Background: Adefovir dipivoxil and lamivudine are oral antiviral agents that have been shown to have potent activity against HBV in vitro and in vivo. Both drugs have been used extensively in patients with HIV infection and more recently in controlled trials as monotherapy in patients with chronic hepatitis B. Lamivudine is currently approved as therapy of hepatitis B and has been evaluated extensively both as a one-year course of treatment as well as long-term continuous therapy. While lamivudine monotherapy induces a transient improvement in viral levels and liver histology, viral resistance develops in a large proportion of patients with re-appearance of HBV DNA in serum in high levels associated with mutations in the Tyrosine-methionine-aspartate-aspartate (YMDD) motif of the HBV polymerase gene and worsening of the hepatitis. Adefovir monotherapy, in contrast, has not been shown to be associated with development of viral resistance even when given for up to two years. When given as monotherapy for 1 year, adefovir leads to improvement in histology of hepatitis B in approximately 50% of patients. At present, the long-term efficacy of adefovir has not been shown.
Protocol: Up to 80 patients with chronic hepatitis B who have raised serum ALT (alanine aminotransferase) levels, HBV DNA in serum (above 1 million copies per ml by quantitative PCR) and active liver disease on liver biopsy will be enrolled and started on the combination of lamivudine (100 mg daily) and adefovir dipivoxil (10 mg daily) or adefovir alone (10 mg daily). Patients will be stratified into one of four groups of 20 patients for randomization: (A) Lamivudine naive and HBeAg positive, (B) Lamivudine naive and HBeAg negative (C) previous lamivudine therapy and HBeAg positive and (D) previous lamivudine therapy and HBeAg negative. Patients will be monitored carefully during therapy for adverse events, clinical symptoms and signs of liver disease, biochemical, and hematological parameters, and HBV serology at 2 to 4 week intervals. The primary endpoint of therapy will be a maintained combined response (a combination of virological, biochemical, and histological response) with major timing of end-points being at 1 and 4 years. Secondary endpoints will include loss of HBeAg, the individual types of maintained responses (virological, biochemical and histological), the development of lamivudine resistance, and improvement in symptom scores and quality of life assessments at 1 and 4 years.
Conclusions: This study will assess the effects of the combination of lamivudine and adefovir dipivoxil compared to adefovir alone in suppressing hepatitis B and prevention of lamivudine resistant mutants that arise during long-term therapy with lamivudine alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lamivudine and adefovir | Experimental | Drug: Lamivudine and adefovir |
| Adefovir | Active comparator | Drug: Adefovir alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than 18 years and above, male or female
- Known serum HBsAg positivity for at least 6 months
- Detectable HBV-DNA in serum above 1 million copies per ml, as detected by quantitative PCR (Roche Cobas Assay)
- Serum ALT (alanine aminotransferase) or AST (aspartate aminotransferase)levels above the upper limit of normal based on two determinations taken at least one month apart during the 6 months before entry
- Liver biopsy within 2 years consistent with chronic hepatitis and with a histology activity index score (HAI) of 6 or more (out of a total possible score of 22) and an "Ishak" fibrosis score of at least 1 (out of a total possible score of 6). For patients with lamivudine resistance the liver biopsy may be performed either on or off lamivudine.
Key exclusion criteria (20 listed)
- Previous or current treatment with adefovir or tenofovir.
- Co-infection with HDV (Hepatitis D Virus) as defined by the presence of both anti-HDV in serum and HDV antigen in liver
- Co-infection with HCV (Hepatitis C Virus) as defined by the presence of both anti-HCV and HCV RNA in serum.
- Co-infection with HIV (Human immunodeficiency virus) as defined by the presence of anti-HIV in serum.
- Decompensated liver disease as defined by serum bilirubin greater than 2.5 mg%, prothrombin time of greater than 2 seconds prolonged, a serum albumin of less than 3.0 gm%, or a history of ascites, variceal bleeding, or hepatic encephalopathy.
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 |
|---|---|---|
| Lamivudine and adefovirLamivudine (100 mg/day) and adefovir (10 mg/day) | Drug | Lamivudine and adefovir |
| Adefovir aloneAdefovir (10 mg/day) | Drug | Adefovir |
Primary outcome
Maintained Combined Response (Virological, Biochemical and Histological Response).
Time frame: 196 weeks from randomization
A maintained combined response was defined as a combination of a virological, biochemical and histological responses at weeks 48 and 192. A virological response was defined as a decrease in HBV DNA levels to undetectable by the Amplicor assay (<500 copies/mL). A biochemical response was defined as a decrease in serum ALT levels into the normal range (<41 U/L). A histological response was defined as a decrease in the HAI score by at least three points with no worsening of the Ishak fibrosis score.
4 secondary outcomes
HBeAg Loss at Week 196
Time frame: Week 196 from randomization
Virological Response
Time frame: Week 196 from randomization
Biological Response
Time frame: week 196 from randomization
Histological Response
Time frame: week 196 from randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8618580Niederau C, Heintges T, Lange S, Goldmann G, Niederau CM, Mohr L, Haussinger D. Long-term follow-up of HBeAg-positive patients treated with interferon alfa for chronic hepatitis B. N Engl J Med. 1996 May 30;334(22):1422-7. doi: 10.1056/NEJM199605303342202.
- Background: PubMed 10787366Malik AH, Lee WM. Chronic hepatitis B virus infection: treatment strategies for the next millennium. Ann Intern Med. 2000 May 2;132(9):723-31. doi: 10.7326/0003-4819-132-9-200005020-00007.
- Background: PubMed 9011789Hoofnagle JH, di Bisceglie AM. The treatment of chronic viral hepatitis. N Engl J Med. 1997 Jan 30;336(5):347-56. doi: 10.1056/NEJM199701303360507. No abstract available.
- Derived from this study: PubMed 22449251Ghany MG, Feld JJ, Zhao X, Heller T, Doo E, Rotman Y, Nagabhyru P, Koh C, Kleiner DE, Wright EC, Liang TJ, Hoofnagle JH. Randomised clinical trial: the benefit of combination therapy with adefovir and lamivudine for chronic hepatitis B. Aliment Pharmacol Ther. 2012 May;35(9):1027-35. doi: 10.1111/j.1365-2036.2012.05059.x. Epub 2012 Mar 26.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Ghany Mark, MD principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lamivudine and adefovir and Adefovir alone in people with HBV (Hepatitis B Virus) and Hepatitis B, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 6 inclusion and 20 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: finished, as of the sponsor's last update on 23 Sep 2016. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maintained Combined Response (Virological, Biochemical and Histological Response). (time frame: 196 weeks from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00023309, which also lists 4 linked publications.
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 23 Sep 2016.