Chronic Hepatitis BPhase 4NCT00778596
Prednisolone Priming Study in Patients With Chronic Hepatitis B
A Phase 4 study testing Prednisolone in people with Chronic Hepatitis B, run by Yun-Fan Liaw at 4 sites in Taiwan.
Trial summary
Study purpose: To investigate whether ALT rebound following corticosteroid priming enhances response to telbivudine therapy. Efficacy assessments: The primary endpoint will be the 1-year HBe-Ag seroconversion rate with or without prednisolone priming. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Prednisolone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 4 sitesTaiwan
- Study dates
- Feb 2009to Dec 2013
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treatment naïve patients or interferon-treated patients 6 months before, or oral antiviral agents treatment ≦ 2 weeks before or treatment < 3 months 1 year prior to screening.
- Male or female, 18 to 65 years of age.
- Documented chronic hepatitis B defined by all of the following:
- Clinical history compatible with compensated chronic hepatitis B.
- Detectable serum hepatitis B surface antigen (HBsAg) >6 months and at the screening visit.
- Hepatitis B e antigen (HBeAg) positive >3 months.
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- Serum HBV DNA > 2x10^5 IU/mL and raised serum ALT > 2xULN but < 5xULN determined on at least 2 occasions 1 month apart before screen or within 3 months of pre-screen, raised serum ALT > 2xULN but < 5xULN determined 1 month apart before screen and at screen.4.
- Liver biopsy showing chronic hepatitis and fibrosis stage ≦ 4 by Ishak classification within 6 months or fibrosis ≦ 4 between 6 to 12 months plus platelet count ≧ 150,000/mm3 or noninvasive assessment (fibroscan or ARFI) of liver fibrosis to excluding liver cirrhosis within 6 months.
- Willing and able to comply with the study drug regimen and all other study requirements.
- Willing and able to provide written informed consent to participate in the study.
Who cannot join
- Patients will be excluded from the study for any of the following reasons:
- Pregnant or nursing.
- Of reproductive potential (men and women) and unwilling to use double-barrier method of contraception (i.e., condom with spermicide or diaphragm with spermicide).
- Co-infection with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV.
- History or clinical signs/symptoms of hepatic decompensation or portal hypertension, such as ascites, presence of esophageal varices or variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis.
- Liver cirrhosis (Ishak fibrosis score 5 or 6).
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- Any medical condition that requires prolonged or frequent use of systemic acyclovir or famciclovir (e.g., for recurrent herpes virus infections).
- History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC, such as suspicious foci on imaging studies or elevated serum alpha-fetoprotein (AFP) levels. A history of treated malignancy other than HCC is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding 3 years.
- One or more known primary or secondary causes of liver disease other than hepatitis B (e.g., alcoholism, non-alcoholic steatohepatitis, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson's disease, other congenital or metabolic conditions affecting the liver, congestive heart failure or other severe cardiopulmonary disease). Gilbert's syndrome and Dubin-Johnson syndrome will not exclude patients from participation in this trial.
- History of clinically evident pancreatitis.
- Currently abusing alcohol (i.e., an average daily intake of more than 40 g of ethanol) or illicit drugs or a history of alcohol abuse or illicit substance abuse within the preceding 2 years. Patients currently on methadone maintenance treatment programs are NOT eligible.
- A medical condition that requires frequent or prolonged use of systemic corticosteroids (e.g., severe asthma, severe arthritis or autoimmune conditions, organ transplantation, adrenal insufficiency).
- A medical condition requiring the chronic or prolonged use of potentially hepatotoxic drugs (dapsone, erythromycin, fluconazole, ketoconazole, rifampin, anti-tuberculosis regimens, etc.). All such drugs must have been discontinued ≥ 30 days prior to randomization.
- A medical condition requiring use of nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, foscarnet, vancomycin, cyclosporine, tacrolimus, or frequent nonsteroidal anti-inflammatory drugs (NSAIDS) or aspirin [administered daily for more than one week at a scheduled dose intended for anti-inflammatory therapy]). All such drugs must have been discontinued ≥ 30 days prior to randomization.
- Any other concurrent medical or psychosocial 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.
- Enrolled or planning to enroll in another clinical trial of an investigational agent while participating in this study.
- Any of the following laboratory values at Screening:
- Hemoglobin (Hb) <11 mg/dL for men or <10 mg/dL for women.
- Total white blood cell count (WBC) <2,500/mm3.
- Absolute neutrophil count (ANC) <1,500/mm3.
- Platelet count <75,000/mm3.
- Serum albumin <3.2 g/dL.
- Total bilirubin ≥2 mg/dL with direct bilirubin > 50% of total bilirubin.
- Serum creatinine >1.0 x ULN.
- Alpha-fetoprotein (AFP) >50 ng/mL (requires further evaluation, to rule-out hepatocellular carcinoma)
- Creatinine clearance (CrCl) <0.83 mL/sec (<50 mL/min) calculated by the laboratory using the modified Cockcroft-Gault method.
- Serum amylase or lipase ³1.5 x ULN.
- Prothrombin time (PT) prolonged by >3 seconds or International Normalized Ratio (INR) > 1.5, based on the upper limits of normal (ULN) of the reference value, despite vitamin K administration.
- Use of any investigational drugs within 30 days or 5 half-lives of randomization, whichever is longer.
- Systemic malignancy within 5 years.
- Previous treatment with telbivudine.
- History of hypersensitivity to components of either telbivudine formulations, or to drugs with similar chemical structures.
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites, 4 recruiting
- Recruiting
Chang Gung Memorial Hospital - Chiayi
Chiayi County
Hui-Ching Chuang, BS, +886-5-3621000 ext. 2005
Shui-Yi Dong, MD
- Not yet recruiting
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City
Chiu-Rong Chen, BS, +886-7-7317123 ext. 8301
Chuan-Mo Lee, MD
- Recruiting
Chang Gung Memorial Hospital - Keelung
Keelung
Yi-Ling Chen, BS, +886-2-24313131 ext. 3181
Rong-Nan Chien, MD
- Recruiting
Chang Gung Memorial Hospital
Linkou, Taoyuan County, 333
Mei-Hsia Ku, MS, +886-3-3281200 ext. 8114, kuvicky1029@gmail.com
Yun-Fan Liaw, MD
About this study
Official title: A Randomized, Double Blind Controlled Trial to Evaluate the Therapeutic Effect of Telbivudine With or Without Prednisolone Priming in Patients With Chronic Hepatitis B
Study purpose:
To investigate whether ALT rebound following corticosteroid priming enhances response to telbivudine therapy.
Read more
Efficacy assessments:
The primary endpoint will be the 1-year HBe-Ag seroconversion rate with or without prednisolone priming.
Data analysis:
A summary table will be presented as frequency tables for categorical variables as number, and percentage, whereas descriptive tables for continuous variables as number, mean ± SD and median (minimum, maximum). All statistical assessments will be two-sided and evaluated at significance level of 0.05. Continuous variables will be analyzed using t-test, or ANOVA, and categorical variables will be analyzed using chi-square or Fisher's exact test. A non-parametric method, Wilcoxon rank-sum or sign-rank tests will be conducted for continuous, and categorical variables if data is far from normal distribution.
Read the detailed description
This is a Phase IV, multi-center, double-blinded, placebo control randomized study to evaluate the therapeutic effect of telbivudine with or without prednisolone priming in patients with chronic hepatitis B.
Patients are allocated to either group A or B randomly.
Group A: Patients initially receive a 4-week course of oral prednisolone (30 mg daily for 3 weeks and then 15 mg daily of 1 week). After a rest period of no treatment for 2 weeks, the patients receive telbivudine therapy at a daily dose of 600 mg for 2 years. Patients will be asked to come back to clinic for follow-up 6 months after telbivudine treatment.
Group B: Patients receive a 4-week course of placebo. After a rest period of no treatment for 2 weeks, the patients receive telbivudine therapy at a daily dose of 600 mg for 2 years. Patients will be asked to come back to clinic for follow-up 6 months after telbivudine treatment.
Eligible patients will be randomized prior to the first dose of study medication. The visit at which the patient receives the first dose will be defined as the study Baseline. Patients will return to the clinic at 3, 4, 6, 10, 14, 18, 30, 44, 58, 72, 86, 98, 110, 116, 122, 128 and 134 weeks post-Baseline. At each of these visits, routine clinical laboratory tests, adverse event inquiry, and other clinical assessments will be performed. Serum samples for HBV DNA analysis will be obtained at 4, 6, 30, 58, 86, 110 and 134 weeks. Serum samples for HBV sequencing will be obtained at Screening and Week 110 (or upon early termination from the study).
Complete physical examinations will be performed at each study visits to evaluate any adverse signs or symptoms reported by the patient.
Serum for HBeAg, antibody to HBeAg (HBeAb), HBsAg, and antibody to HBsAg (HBsAb) will be obtained at Screening, Baseline, and Weeks 6, 30, 58, 86, 110 and 134(or upon early termination from the study), and at all protocol-required follow-up visits.
Patients will be followed monthly for 6 months after discontinuation of study drug(s).
- Conditions
- Chronic Hepatitis B
- Being tested
- Prednisolone, Placebo priming
- Keywords
- Hepatitis B, Telbivudine, Prednisolone
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
Prednisolone priming for 4 weeks, then followed a telbivudine treatment for 2 years.
Placebo primingDrug
Also called Placebo
Prednisolone priming for 4 weeks, then followed a telbivudine treatment for 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone priming | Experimental | Prednisolone priming 4 weeks, then treated with telbivudine. Receives: Drug: Prednisolone |
| Placebo priming | Placebo comparator | Placebo priming for 4 weeks, then followed a telbivudine treatment for 2 years. Receives: Drug: Placebo priming |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the 1-year HBe-Ag seroconversion rate with or without prednisolone priming.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2008 (estimated)
- Study startFeb 2009
- Primary completionDec 2012 (estimated)
- Study completionDec 2013 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yun-Fan Liaw
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Responsible party
- Sponsor-investigator, Yun-Fan Liaw, Chang Gung Memorial Hospital
- Investigators
- Yun-Fan Liaw, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778596
- Sponsor's protocol ID
- CST-L-1
- Status last verified
- May 2012
- First submitted
- 21 Oct 2008
- Last updated
- 25 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind Controlled Trial to Evaluate the Therapeutic Effect of Telbivudine With or Without Prednisolone Priming in Patients With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT00778596
- Acronym / sponsor ID
- CST-L-1
- Conditions
- Chronic Hepatitis B
- Keywords
- Hepatitis B, Telbivudine, Prednisolone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Yun-Fan LiawUniversity, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Study start
- Feb 2009
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 23 Oct 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.
Study purpose:
To investigate whether ALT rebound following corticosteroid priming enhances response to telbivudine therapy.
Efficacy assessments:
The primary endpoint will be the 1-year HBe-Ag seroconversion rate with or without prednisolone priming.
Data analysis:
A summary table will be presented as frequency tables for categorical variables as number, and percentage, whereas descriptive tables for continuous variables as number, mean ± SD and median (minimum, maximum). All statistical assessments will be two-sided and evaluated at significance level of 0.05. Continuous variables will be analyzed using t-test, or ANOVA, and categorical variables will be analyzed using chi-square or Fisher's exact test. A non-parametric method, Wilcoxon rank-sum or sign-rank tests will be conducted for continuous, and categorical variables if data is far from normal distribution.
Detailed description
This is a Phase IV, multi-center, double-blinded, placebo control randomized study to evaluate the therapeutic effect of telbivudine with or without prednisolone priming in patients with chronic hepatitis B.
Patients are allocated to either group A or B randomly.
Group A: Patients initially receive a 4-week course of oral prednisolone (30 mg daily for 3 weeks and then 15 mg daily of 1 week). After a rest period of no treatment for 2 weeks, the patients receive telbivudine therapy at a daily dose of 600 mg for 2 years. Patients will be asked to come back to clinic for follow-up 6 months after telbivudine treatment.
Group B: Patients receive a 4-week course of placebo. After a rest period of no treatment for 2 weeks, the patients receive telbivudine therapy at a daily dose of 600 mg for 2 years. Patients will be asked to come back to clinic for follow-up 6 months after telbivudine treatment.
Eligible patients will be randomized prior to the first dose of study medication. The visit at which the patient receives the first dose will be defined as the study Baseline. Patients will return to the clinic at 3, 4, 6, 10, 14, 18, 30, 44, 58, 72, 86, 98, 110, 116, 122, 128 and 134 weeks post-Baseline. At each of these visits, routine clinical laboratory tests, adverse event inquiry, and other clinical assessments will be performed. Serum samples for HBV DNA analysis will be obtained at 4, 6, 30, 58, 86, 110 and 134 weeks. Serum samples for HBV sequencing will be obtained at Screening and Week 110 (or upon early termination from the study).
Complete physical examinations will be performed at each study visits to evaluate any adverse signs or symptoms reported by the patient.
Serum for HBeAg, antibody to HBeAg (HBeAb), HBsAg, and antibody to HBsAg (HBsAb) will be obtained at Screening, Baseline, and Weeks 6, 30, 58, 86, 110 and 134(or upon early termination from the study), and at all protocol-required follow-up visits.
Patients will be followed monthly for 6 months after discontinuation of study drug(s).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisolone priming | Experimental | Drug: PrednisolonePrednisolone priming 4 weeks, then treated with telbivudine. |
| Placebo priming | Placebo comparator | Drug: Placebo primingPlacebo priming for 4 weeks, then followed a telbivudine treatment for 2 years. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Treatment naïve patients or interferon-treated patients 6 months before, or oral antiviral agents treatment ≦ 2 weeks before or treatment < 3 months 1 year prior to screening.
- Male or female, 18 to 65 years of age.
- Documented chronic hepatitis B defined by all of the following:
- Liver biopsy showing chronic hepatitis and fibrosis stage ≦ 4 by Ishak classification within 6 months or fibrosis ≦ 4 between 6 to 12 months plus platelet count ≧ 150,000/mm3 or noninvasive assessment (fibroscan or ARFI) of liver fibrosis to excluding liver cirrhosis within 6 months.
- Willing and able to comply with the study drug regimen and all other study requirements.
Key exclusion criteria (32 listed)
- Pregnant or nursing.
- Of reproductive potential (men and women) and unwilling to use double-barrier method of contraception (i.e., condom with spermicide or diaphragm with spermicide).
- Co-infection with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV.
- History or clinical signs/symptoms of hepatic decompensation or portal hypertension, such as ascites, presence of esophageal varices or variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis.
- Liver cirrhosis (Ishak fibrosis score 5 or 6).
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 |
|---|---|---|
| PrednisolonePrednisolone priming for 4 weeks, then followed a telbivudine treatment for 2 years. | Drug | Prednisolone priming |
| Placebo primingAlso: PlaceboPrednisolone priming for 4 weeks, then followed a telbivudine treatment for 2 years. | Drug | Placebo priming |
Primary outcome
The primary endpoint will be the 1-year HBe-Ag seroconversion rate with or without prednisolone priming.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 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.
Yun-Fan Liaw, MD principal investigator
Chang Gung Memorial Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisolone in people with Chronic Hepatitis B, run by Yun-Fan Liaw at 4 sites in Taiwan.
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 10 inclusion and 32 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: status not confirmed, as of the sponsor's last update on 25 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mei-Hsia Ku, MS (+886-3-3281200 ext. 8114, kuvicky1029@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint will be the 1-year HBe-Ag seroconversion rate with or without prednisolone priming. (time frame: 1 year). 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 25 May 2012.