Prednisolone Priming Study in Patients With Chronic Hepatitis B

NCT00778596 | Unknown Phase 4

• 1 other identifier: CST-L-1
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Chronic Hepatitis B

Keywords

Hepatitis B; Telbivudine; Prednisolone

Outcome Measures

Primary Outcomes (1)

• The primary endpoint will be the 1-year HBe-Ag seroconversion rate with or without prednisolone priming.

  1 year

Study Arms (2)

Prednisolone priming

EXPERIMENTAL

Prednisolone priming 4 weeks, then treated with telbivudine.

Drug: Prednisolone

Placebo priming

PLACEBO COMPARATOR

Placebo priming for 4 weeks, then followed a telbivudine treatment for 2 years.

Drug: Placebo priming

Interventions

Prednisolone DRUG

Prednisolone priming for 4 weeks, then followed a telbivudine treatment for 2 years.

Prednisolone priming

Placebo priming DRUG

Prednisolone priming for 4 weeks, then followed a telbivudine treatment for 2 years.

Also known as: Placebo

Placebo priming

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Yun-Fan Liaw: lead
• Chang Gung Memorial Hospital: collaborator

Study Sites (4)

Chang Gung Memorial Hospital - Chiayi

Chiayi County, Taiwan

RECRUITING

Chang Gung Memorial Hospital - Kaohsiung

Kaohsiung City, Taiwan

NOT YET RECRUITING

Chang Gung Memorial Hospital - Keelung

Keelung, Taiwan

RECRUITING

Chang Gung Memorial Hospital

Linkou, Taoyuan County, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Yun-Fan Liaw, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei-Hsia Ku, MS

CONTACT

+886-3-3281200; kuvicky1029@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Yun-Fan Liaw

Study Record Dates

• First Submitted: October 21, 2008
• First Posted: October 23, 2008
• Study Start: February 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: May 25, 2012

Record last verified: 2012-05

Locations

TW (4)