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Sponsored by: |
Chang Gung Memorial Hospital |
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Information provided by: | Chang Gung Memorial Hospital |
ClinicalTrials.gov Identifier: | NCT00778596 |
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.
Condition | Intervention | Phase |
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Chronic Hepatitis B |
Drug: Prednisolone Drug: Placebo priming |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy 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 |
Estimated Enrollment: | 160 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Prednisolone priming: Experimental
Prednisolone priming 4 weeks, then treated with telbivudine.
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Drug: Prednisolone
Prednisolone priming for 4 weeks, then followed a telbivudine treatment for 2 years.
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Placebo priming: Placebo Comparator
Placebo priming for 4 weeks, then followed a telbivudine treatment for 2 years.
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Drug: Placebo priming
Prednisolone priming for 4 weeks, then followed a telbivudine treatment for 2 years.
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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).
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Documented chronic hepatitis B defined by all of the following:
Exclusion Criteria:
Patients will be excluded from the study for any of the following reasons:
Any of the following laboratory values at Screening:
Taiwan | |
Chang Gung Memorial Hospital | |
Linkou, Taoyuan County, Taiwan, 333 | |
Chang Gung Memorial Hospital - Chiayi | |
Chiayi County, Taiwan | |
Chang Gung Memorial Hospital - Keelung | |
Keelung City, Taiwan | |
Chang Gung Memorial Hospital - Kaohsiung | |
Kaohsiung City, Taiwan |
Principal Investigator: | Yun-Fan Liaw, MD | Chang Gung Memorial Hospital |
Responsible Party: | Chang Gung Memorial Hospital ( Yun-Fan Liaw/Visiting Staff ) |
Study ID Numbers: | CST-L-1 |
Study First Received: | October 21, 2008 |
Last Updated: | November 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00778596 History of Changes |
Health Authority: | Taiwan: Institutional Review Board |
Hepatitis B Telbivudine Prednisolone |
Anti-Inflammatory Agents Liver Diseases Antineoplastic Agents, Hormonal Hepatitis, Chronic Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hepatitis, Viral, Human Methylprednisolone acetate Prednisolone acetate Neuroprotective Agents |
Hormones Glucocorticoids Hepatitis Virus Diseases Digestive System Diseases Hepatitis B, Chronic Prednisolone Hepatitis B DNA Virus Infections Peripheral Nervous System Agents Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Liver Diseases Hepatitis, Chronic Methylprednisolone Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hepatitis, Viral, Human Antiemetics Prednisolone acetate Neuroprotective Agents Hepadnaviridae Infections Hormones Hepatitis B, Chronic Therapeutic Uses |
Hepatitis B Methylprednisolone Hemisuccinate Antineoplastic Agents, Hormonal Gastrointestinal Agents Methylprednisolone acetate Protective Agents Glucocorticoids Pharmacologic Actions Virus Diseases Hepatitis Digestive System Diseases Autonomic Agents Prednisolone DNA Virus Infections Peripheral Nervous System Agents |