Follow Up of Patients Chronic Hepatitis B (CHB) Treated With Sebivo Using the 13C Methacetin Breath Test

NCT01204827 | Withdrawn Phase 2

• 1 other identifier: CLDT600AIL02T
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with HBeAg negative chronic HBV and evidence of hepatic disease (elevated liver enzymes or evidence of cirrhosis) who have significant viremia are treated with anti HBV therapy. Currently the key goals of anti HBV therapy are profound and prolonged viral suppression and treatment efficacy is assessed by monitoring viral load and liver enzymes. However these do not always reflect the degree of liver impairment or the degree of improvement in response to therapy. Sebivo has been accepted in Israel as a first line therapy for HBeAg negative and HBeAg positive chronic HBV with evidence of liver damage. Viral load should decrease by 1 log every 3 months, otherwise patients should be offered add-on or alternative therapy. As the majority of patients in Israel are HBeAg negative chronic HBV and in order to have homogenous population we will select for our study only patients with HBeAg negative chronic HBV. The 13C Methacetin breath test, assess liver function and specifically the function of the microsomal CYP4501A2. It has been shown to correlate with the degree of liver impairment and with clinical outcomes in both acute and chronic liver disease. The aim of this study is to determine the utility of the 13C Methacetin Breath Test to follow up patients with HBeAg negative chronic HBV receiving anti viral therapy.

Conditions

Chronic Hepatitis B

Keywords

Patients with chronic HBeAg negative hepatitis B virus infection treated with Sebivo (Telbivudine)

Study Arms (1)

CHBV Sebivo

EXPERIMENTAL

Device: 13C Methacetin Breath Test (BreathID)

Interventions

13C Methacetin Breath Test (BreathID) DEVICE

CHBV Sebivo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, at least 18 years of age.
• Documented chronic hepatitis B (CHB) infection defined by all of the following:
• Clinical history compatible with CHB
• HBeAg negative chronic hepatitis B patients
• Detectable serum HBsAg at least 6 months prior to screening
• Serum HBV DNA level ≥ 2000 IU/mL as determined by either the Abbott or Roche Taqman assay at Screening visit
• For patients with cirrhosis, clinical history and lab tests compatible with compensated liver disease
• Elevated serum ALT level \> x 1 ULN and \< x 10 ULN) at Screening visit (ULN being 30 IU/mL)
• If ALT level ≤ x 1 ULN must have available liver histology report within 12 months before screening which indicates chronic hepatitis. If not available, liver biopsy is required at baseline.
• Patient is willing and able to comply with the study drug regimen and all other study requirements.
• The patient is willing and able to provide written informed consent to participate in the study.

You may not qualify if:

• History of hypersensitivity to any of the study drugs (Methacetin, Sebivo) or to drugs with similar chemical structures, including allergy to paracetamol.
• Patient is pregnant or breastfeeding.
• 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. The exception of the aforementioned criteria will be given if 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/ml (IU/L) or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy or have been surgically sterilized (e.g., bilateral tubal ligation) or the patient must agree to use two methods of birth control. This is any combination of hormonal contraception (implantable, patch, oral or injection), IUD, male or female condom with spermicidal gel, diaphragm, sponge or cervical cap. Women of childbearing potential must have a negative serum betahuman chorionic gonadotropin (β-HCG) during
• Males capable of reproduction, defined as all men physiologically capable of producing sperm, including men whose career, lifestyle, or sexual orientation precludes intercourse with a female partner UNLESS the female partner meets the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \>40 mIU/ml (IU/L) or the patient must agree to use two methods of birth control. This is any combination of hormonal contraception (implantable, patch ,oral or injection), IUD, male or female condom with spermicidal gel, diaphragm, sponge or cervical cap.
• Patient is co-infected with HCV, HDV, or HIV.
• Severe uncontrolled disease of other organ (heart, kidney, lung).
• Patients who have previously been involved in a trial with telbivudine.
• Patient has received nucleoside or nucleotide drugs whether approved or investigational at any time.
• Patient has received IFN or other immunomodulatory treatment in the 6 months before Screening for this study.
• Patient has a history of or clinical signs/symptoms of hepatic decompensation such as ascites, esophageal variceal bleeding, hepatic encephalopathy, hepatorenal syndrome, hepatic hydrothorax, hepatopulmonary syndrome or spontaneous bacterial peritonitis, among others.
• Patient has a medical condition that requires prolonged or frequent use of systemic acyclovir or famciclovir.
• Patient has a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. Patients with previous findings suggestive of possible hepatocellular carcinoma (HCC), should have the disease ruled out prior to entrance into 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.
• Patient has a medical condition that requires frequent or prolonged use of systemic corticosteroids, although inhaled corticosteroids are allowed.
• Patient has a history of clinical and laboratory evidence of chronic renal insufficiency (Estimated calculated serum creatinine clearance \< 50)

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Liver Unit, Hadassah Hebrew University Medical Center

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: September 17, 2010
• Last Updated: August 28, 2012

Record last verified: 2011-06

Locations

IL (1)