Chronic Hepatitis BPhase 2NCT00804622
Effects of Telbivudine and Tenofovir Disproxil Fumarate on the Kinetics of Hepatitis B Virus DNA in Chronic Hepatitis B (CHB)
A Phase 2 study testing telbivudine, tenofovir disproxil fumarate and telbivudine plus tenofovir disproxil fumarate in people with Chronic Hepatitis B, run by The University of Hong Kong at 1 site in China.
Trial summary
The purpose of this study is to compare the safety, tolerability and effectiveness of 12 weeks of treatment with telbivudine 600 mg daily plus tenofovir DF 300 mg once daily (QD) taken together versus tenofovir DF 300 mg once daily (QD) or versus telbivudine 600 mg monotherapy daily (QD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- telbivudine, tenofovir disproxil fumarate and telbivudine plus tenofovir disproxil fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- Dec 2008to Mar 2010
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following inclusion criteria at screening to be eligible for participation in this study.
- Chronic HBV infection, defined as positive serum HBsAg for at least 6 months, or HBsAg positive > 3 months and negative for IgM anti-HBc and positive for IgG anti-HBc
- Age < 40 years old
- HBeAg positive
- HBV DNA ≥ 10^7 copies/mL by Abbott real-time PCR
- ALT ≤ 1 ULN
Show all 14Show fewer
- Willing and able to provide written informed consent
- Negative serum β-HCG (for females of childbearing potential only)
- Calculated creatinine clearance ≥ 70 mL/min by the following formula: (140 - age in years) x (body weight [kg]) / (72) x (serum creatinine [mg/dl]) [Note: multiply estimated rate by 0.85 for women]
- Hemoglobin ≥ 10 g/dL
- Neutrophils ≥ 1,500 /mm^3
- No prior oral HBV therapy (e.g., nucleotide and/or nucleoside therapy or other investigational agents for HBV infection)
- Is willing and able to comply with the study drug regimen and all other study procedures and requirements
- Is willing and able to provide written informed consent before any study assessment is perform.
Who cannot join
- Patients will be excluded from the study for any of the criteria:
- Decompensated liver disease defined as direct (conjugated) bilirubin > 1.2 × ULN, PT > 1.2 × ULN, platelets < 150,000/mm3, serum albumin < 3.5 g/dL, or prior history of clinical hepatic decompensation (e.g. ascites, jaundice, encephalopathy, variceal hemorrhage).
- Received interferon (pegylated or not) therapy within 6 months of the screening visit
- α-fetoprotein > 50 ng/mL
- Evidence of hepatocellular carcinoma (HCC)
- Co-infection with HCV (by serology), HIV, or HDV.
Show all 17Show fewer
- Significant renal, cardiovascular, pulmonary, or neurological disease.
- Received solid organ or bone marrow transplantation.
- Is currently receiving therapy with immunomodulators (e.g., corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion.
- Has proximal tubulopathy.
- Use of other investigational drugs at the time of enrollment, or within 30 days
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
- Is pregnant or breastfeeding. Women of childbearing potential must have a negative serum β - HCG during Screening.
- Is a women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap).
- Patient has any other concurrent medical or social condition likely to preclude compliance with the schedule of evaluations in the protocol, or likely to confound the efficacy or safety observations of the study.
- Patient is currently abusing alcohol or illicit drugs, or has a history of alcohol abuse or illicit substance abuse within the preceding two years. Please refer to Appendix 3.
- Patient has a medical condition that requires prolonged or frequent use of systemic acyclovir or famciclovir. Please refer to Appendix 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Controlled, Exploratory Trial to Characterize the Results of Daily Oral Administration of Telbivudine 600 mg and Tenofovir Disproxil Fumarate 300 mg in Combination or Telbivudine 600 mg or Tenofovir Disproxil Fumarate 300 mg Monotherapy Given Over 12 Weeks on the Kinetics of Hepatitis B Virus DNA in Adults With HBeAg Positive Compensated CHB
The purpose of this study is to compare the safety, tolerability and effectiveness of 12 weeks of treatment with telbivudine 600 mg daily plus tenofovir DF 300 mg once daily (QD) taken together versus tenofovir DF 300 mg once daily (QD) or versus telbivudine 600 mg monotherapy daily (QD). This is an open-labeled, active controlled, viral kinetics study which means the subjects and study doctor will know what study drug subjects have been assigned. This study is open to male and female subjects, <40 years of age, who have been infected with HBV for at least 6 months and have not received oral treatment for HBV.
Read the detailed description
The primary goal of therapy for chronic hepatitis B (CHB) is suppression of viral replication. Long-term suppression of serum HBV DNA is likely to reduce progression to cirrhosis and hepatic decompensation and decrease the risk of hepatocellular carcinoma. Conventional treatment of chronic hepatitis B is limited by low rates of sustained hepatitis B virus DNA suppression and hepatitis B e antigen (HBeAg) seroconversion, increasing rates of drug resistance to the oral agents, and poor tolerability of interferon.
Currently, several nucleoside/nucleotide analogues are available for treatment of CHB. Typically, treatment is continued indefinitely since discontinuation is usually associated with relapse . However, the safety implications related to long term treatment are still unknown.
Previously published studies using combinations (peginterferon alpha-2a + lamivudine) (Marcellin 2004; Lau 2005; Janssen 2005) have shown combinations to be more potent in HBeAg loss at the end of dosing, than either agent used as monotherapy; off-treatment differences, however, did not persist. There are no treatment paradigms as yet of combination therapy with two nucleoside analogues for use in treatment-naive patients.
In summary, there is an unmet need for improved anti-HBV therapy and there are still several controversies such as treatment options, potential role of combination therapy versus monotherapy and optimal duration of therapy, among others. Clinical trials are underway to answer some of these questions. This study aims to assess whether or not combination therapy with telbuvudine and tenofovir DF has superior antiviral efficacy when compared to tenofovir DF or telbuvidine monotherapy. The study will also determine the safety of the combination of telbivudine and tenofovir disoproxil fumarate in patients with chronic hepatitis B. Patients in the immunotolerant phase of CHB will be include in the study. This phase is characterized for high viremia and normal transaminases. Since these patients are not considered as candidates for CHB therapy according to international guidelines (Lok et al 2007), treatment discontinuation after 12 weeks does not raise any unethical implications.
REFERENCES:
- Janssen HL, van Zonneveld M, Senturk H, Zeuzem S, Akarca US, Cakaloglu Y, Simon C, So TM, Gerken G, de Man RA, Niesters HG, Zondervan P, Hansen B, Schalm SW; HBV 99-01 Study Group; Rotterdam Foundation for Liver Research. Pegylated interferon alfa-2b alone or in combination with lamivudine for HBeAg-positive chronic hepatitis B: a randomised trial. Lancet. 2005 Jan 8-14;365(9454):123-9.
- Lau GK, Piratvisuth T, Luo KX, Marcellin P, Thongsawat S, Cooksley G, Gane E, Fried MW, Chow WC, Paik SW, Chang WY, Berg T, Flisiak R, McCloud P, Pluck N; Peginterferon Alfa-2a HBeAg-Positive Chronic Hepatitis B Study Group. Peginterferon Alfa-2a, lamivudine, and the combination for HBeAg-positive chronic hepatitis B. N Engl J Med. 2005 Jun 30; 352(26):2682-95.
- Lok AS, McMahon BJ. (2007) Chronic hepatitis. Hepatology 45(2):507-39.
- Marcellin P, Lau GK, Bonino F, Farci P, Hadziyannis S, Jin R, Lu ZM, Piratvisuth T, Germanidis G, Yurdaydin C, Diago M, Gurel S, Lai MY, Button P, Pluck N; Peginterferon Alfa-2a HBeAg-Negative Chronic Hepatitis B Study Group. Peginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B. N Engl J Med. 2004 Sep 16;351(12):1206-17.
Primary objectives:
The primary objective of this study is to characterize the reduction in HBV DNA level from Baseline to week 12 of telbivudine plus tenofovir DF combination therapy versus telbivudine or tenofovir DF monotherapy.
Secondary objectives:
Secondary objectives of the study include describing the following for telbivudine plus tenofovir DF combination therapy versus telbivudine or tenofovir DF monotherapy:
- reduction in HBV DNA level from Baseline to Weeks 2, 4, and 8
- characterization of early viral kinetics through estimation of various parameters such as efficiency of blocking new virus production, and half-lives of free virions and infected heptocytes
- % patients who are PCR negative at Week 12 (defined as <25 copies/mL)
- % of patients who achieve HBeAg loss and HBeAg seroconversion at Week 12
- safety
Exploratory objectives:
- To explore HBeAg and HBsAg levels over the treatment period as an additional potential predictor of efficacy.
- To explore additional potential early serological and immunological markers for prediction of efficacy or safety.
- Conditions
- Chronic Hepatitis B
- Being tested
- telbivudine, tenofovir disproxil fumarate, telbivudine plus tenofovir disproxil fumarate
- Keywords
- HBeAg positive compensated 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.
telbivudineDrug
daily oral administration,600mg,over 12 weeks
tenofovir disproxil fumarateDrug
daily oral administration,300mg,over 12 weeks
telbivudine plus tenofovir disproxil fumarateDrug
daily oral administration of telbivudine 600 mg and tenofovir disproxil fumarate 300 mg in combination given over 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | tenofovir disproxil fumarate 300 mg monotherapy Receives: Drug: tenofovir disproxil fumarate |
| 2 | Active comparator | telbivudine 600 mg monotherapy Receives: Drug: telbivudine |
| 3 | Active comparator | telbivudine 600 mg and tenofovir disproxil fumarate 300 mg Receives: Drug: telbivudine plus tenofovir disproxil fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary variable is the reduction of HBV DNA level over 12 weeks of treatment
Measured: 12 weeks
Secondary outcomes (4)
Reduction in HBV DNA level
Measured: from baseline to Weeks 2, 4 and 8
Characterization of very early viral kinetics through estimation of various parameters
Measured: week 12
% patients who are PCR negative
Measured: Week 12
% of patients who achieve HBeAg loss and HBeAg seroconversion
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2009
- Study completionMar 2010
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.
- More trials run by The University of Hong KongThe 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Investigators
- George Lau, MD, Principal investigator, Department of Medicine, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804622
- Sponsor's protocol ID
- CLDT600AHK01
- Status last verified
- Jul 2012
- First submitted
- 8 Dec 2008
- Last updated
- 11 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Controlled, Exploratory Trial to Characterize the Results of Daily Oral Administration of Telbivudine 600 mg and Tenofovir Disproxil Fumarate 300 mg in Combination or Telbivudine 600 mg or Tenofovir Disproxil Fumarate 300 mg Monotherapy Given Over 12 Weeks on the Kinetics of Hepatitis B Virus DNA in Adults With HBeAg Positive Compensated CHB
- ClinicalTrials.gov ID
- NCT00804622
- Acronym / sponsor ID
- CLDT600AHK01
- Conditions
- Chronic Hepatitis B
- Keywords
- HBeAg positive compensated chronic hepatitis B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Dec 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 9 Dec 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.
The purpose of this study is to compare the safety, tolerability and effectiveness of 12 weeks of treatment with telbivudine 600 mg daily plus tenofovir DF 300 mg once daily (QD) taken together versus tenofovir DF 300 mg once daily (QD) or versus telbivudine 600 mg monotherapy daily (QD). This is an open-labeled, active controlled, viral kinetics study which means the subjects and study doctor will know what study drug subjects have been assigned. This study is open to male and female subjects, <40 years of age, who have been infected with HBV for at least 6 months and have not received oral treatment for HBV.
Detailed description
The primary goal of therapy for chronic hepatitis B (CHB) is suppression of viral replication. Long-term suppression of serum HBV DNA is likely to reduce progression to cirrhosis and hepatic decompensation and decrease the risk of hepatocellular carcinoma. Conventional treatment of chronic hepatitis B is limited by low rates of sustained hepatitis B virus DNA suppression and hepatitis B e antigen (HBeAg) seroconversion, increasing rates of drug resistance to the oral agents, and poor tolerability of interferon.
Currently, several nucleoside/nucleotide analogues are available for treatment of CHB. Typically, treatment is continued indefinitely since discontinuation is usually associated with relapse . However, the safety implications related to long term treatment are still unknown.
Previously published studies using combinations (peginterferon alpha-2a + lamivudine) (Marcellin 2004; Lau 2005; Janssen 2005) have shown combinations to be more potent in HBeAg loss at the end of dosing, than either agent used as monotherapy; off-treatment differences, however, did not persist. There are no treatment paradigms as yet of combination therapy with two nucleoside analogues for use in treatment-naive patients.
In summary, there is an unmet need for improved anti-HBV therapy and there are still several controversies such as treatment options, potential role of combination therapy versus monotherapy and optimal duration of therapy, among others. Clinical trials are underway to answer some of these questions. This study aims to assess whether or not combination therapy with telbuvudine and tenofovir DF has superior antiviral efficacy when compared to tenofovir DF or telbuvidine monotherapy. The study will also determine the safety of the combination of telbivudine and tenofovir disoproxil fumarate in patients with chronic hepatitis B. Patients in the immunotolerant phase of CHB will be include in the study. This phase is characterized for high viremia and normal transaminases. Since these patients are not considered as candidates for CHB therapy according to international guidelines (Lok et al 2007), treatment discontinuation after 12 weeks does not raise any unethical implications.
REFERENCES:
- Janssen HL, van Zonneveld M, Senturk H, Zeuzem S, Akarca US, Cakaloglu Y, Simon C, So TM, Gerken G, de Man RA, Niesters HG, Zondervan P, Hansen B, Schalm SW; HBV 99-01 Study Group; Rotterdam Foundation for Liver Research. Pegylated interferon alfa-2b alone or in combination with lamivudine for HBeAg-positive chronic hepatitis B: a randomised trial. Lancet. 2005 Jan 8-14;365(9454):123-9.
- Lau GK, Piratvisuth T, Luo KX, Marcellin P, Thongsawat S, Cooksley G, Gane E, Fried MW, Chow WC, Paik SW, Chang WY, Berg T, Flisiak R, McCloud P, Pluck N; Peginterferon Alfa-2a HBeAg-Positive Chronic Hepatitis B Study Group. Peginterferon Alfa-2a, lamivudine, and the combination for HBeAg-positive chronic hepatitis B. N Engl J Med. 2005 Jun 30; 352(26):2682-95.
- Lok AS, McMahon BJ. (2007) Chronic hepatitis. Hepatology 45(2):507-39.
- Marcellin P, Lau GK, Bonino F, Farci P, Hadziyannis S, Jin R, Lu ZM, Piratvisuth T, Germanidis G, Yurdaydin C, Diago M, Gurel S, Lai MY, Button P, Pluck N; Peginterferon Alfa-2a HBeAg-Negative Chronic Hepatitis B Study Group. Peginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B. N Engl J Med. 2004 Sep 16;351(12):1206-17.
Primary objectives:
The primary objective of this study is to characterize the reduction in HBV DNA level from Baseline to week 12 of telbivudine plus tenofovir DF combination therapy versus telbivudine or tenofovir DF monotherapy.
Secondary objectives:
Secondary objectives of the study include describing the following for telbivudine plus tenofovir DF combination therapy versus telbivudine or tenofovir DF monotherapy:
- reduction in HBV DNA level from Baseline to Weeks 2, 4, and 8
- characterization of early viral kinetics through estimation of various parameters such as efficiency of blocking new virus production, and half-lives of free virions and infected heptocytes
- % patients who are PCR negative at Week 12 (defined as <25 copies/mL)
- % of patients who achieve HBeAg loss and HBeAg seroconversion at Week 12
- safety
Exploratory objectives:
- To explore HBeAg and HBsAg levels over the treatment period as an additional potential predictor of efficacy.
- To explore additional potential early serological and immunological markers for prediction of efficacy or safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: tenofovir disproxil fumaratetenofovir disproxil fumarate 300 mg monotherapy |
| 2 | Active comparator | Drug: telbivudinetelbivudine 600 mg monotherapy |
| 3 | Active comparator | Drug: telbivudine plus tenofovir disproxil fumaratetelbivudine 600 mg and tenofovir disproxil fumarate 300 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must meet all of the following inclusion criteria at screening to be eligible for participation in this study.
- Chronic HBV infection, defined as positive serum HBsAg for at least 6 months, or HBsAg positive > 3 months and negative for IgM anti-HBc and positive for IgG anti-HBc
- Age < 40 years old
- HBeAg positive
- HBV DNA ≥ 10^7 copies/mL by Abbott real-time PCR
Key exclusion criteria (17 listed)
- Decompensated liver disease defined as direct (conjugated) bilirubin > 1.2 × ULN, PT > 1.2 × ULN, platelets < 150,000/mm3, serum albumin < 3.5 g/dL, or prior history of clinical hepatic decompensation (e.g. ascites, jaundice, encephalopathy, variceal hemorrhage).
- Received interferon (pegylated or not) therapy within 6 months of the screening visit
- α-fetoprotein > 50 ng/mL
- Evidence of hepatocellular carcinoma (HCC)
- Co-infection with HCV (by serology), HIV, or HDV.
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 |
|---|---|---|
| telbivudinedaily oral administration,600mg,over 12 weeks | Drug | 2 |
| tenofovir disproxil fumaratedaily oral administration,300mg,over 12 weeks | Drug | 1 |
| telbivudine plus tenofovir disproxil fumaratedaily oral administration of telbivudine 600 mg and tenofovir disproxil fumarate 300 mg in combination given over 12 weeks | Drug | 3 |
Primary outcome
The primary variable is the reduction of HBV DNA level over 12 weeks of treatment
Time frame: 12 weeks
4 secondary outcomes
Reduction in HBV DNA level
Time frame: from baseline to Weeks 2, 4 and 8
Characterization of very early viral kinetics through estimation of various parameters
Time frame: week 12
% patients who are PCR negative
Time frame: Week 12
% of patients who achieve HBeAg loss and HBeAg seroconversion
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 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.
George Lau, MD principal investigator
Department of Medicine, The University of Hong Kong
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 telbivudine, tenofovir disproxil fumarate and telbivudine plus tenofovir disproxil fumarate in people with Chronic Hepatitis B, run by The University of Hong Kong at 1 site in China.
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 14 inclusion and 17 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 11 Jul 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 variable is the reduction of HBV DNA level over 12 weeks of treatment (time frame: 12 weeks). 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 11 Jul 2012.