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Chronic Hepatitis BPhase 2/3NCT01204827

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

A Phase 2/3 study testing 13C Methacetin Breath Test (BreathID) in people with Chronic Hepatitis B, run by Hadassah Medical Organization at 1 site in Israel.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Hepatitis B
What is being tested?
13C Methacetin Breath Test (BreathID)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteIsrael
Study dates
Start not givento not given
Phase
Phase 2/3
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 75 years
  • All sexes
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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).
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  • 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 has one or more additional known primary or secondary causes of liver disease other than CHB, including steatohepatitis and autoimmune hepatitis among other liver diseases. Gilbert's syndrome and Dubin-Johnson syndrome are not considered exclusion criteria for this study.
  • History of any other acute or chronic medical condition that in the opinion of the investigator would make the patient unsuitable for inclusion 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)
  • Patient has a medical condition requiring the chronic or prolonged use of potentially hepatotoxic drugs or nephrotoxic drugs.
  • 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.
  • Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
  • Patient has a history of myopathy, myositis, or persistent muscle weakness.
  • Patient has any of the following laboratory values during Screening:
  • Hemoglobin <11 g/dL (110 g/L) for men or <10 g/dL (100 g/L) for women
  • Total WBC <3,500/mm3 (3.5 x 109/Liter)
  • Absolute neutrophil count (ANC) <1,500/mm3 (1.5 x 109/Liter)
  • Platelet count <75,000/mm3 (75 x 109/Liter)
  • Serum amylases or lipase ≥ 1.5 x ULN
  • Serum albumin <3.3 g/dL (33g/L)
  • Total bilirubin ≥ 2.0 mg/dL (34.2 μmol/L)
  • Estimated calculated serum creatinine clearance < 50 mL/min ( 0.48 ml/s) using the Cockcroft-Gault method with lean or ideal body weight; see Glossary of Terms (Cockcroft 1976)
  • AFP > 50 ng/mL or μg/L (requires further work up per local medical standards)
  • Patient has not fasted for 8 hours.
  • Patient has smoked on the day of the test.
  • Patient that has taken drugs that can interfere with methacetin metabolism: fluvoxamine, amiodarone, ciprofloxacin, cimetidine, rifampin, carbamazepine within the last 24 hours.
  • Patient has taken Tylenol or any other acetaminophen related medications within the past 24 hours.
  • Patients that received any new medication in the last 48 hours.
  • Patients that still suffer from any previous clinical intervention (e.g. biopsy)
  • Patients who have not consumed alcohol 24 hours prior the MBT or consume alcohol on a regular basis more than 40gr for male and 20gr for female per day.

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Liver Unit, Hadassah Hebrew University Medical Center

    Jerusalem, 91120

Other trials in Israel

About this study

Official title: Follow Up of Patients With HBeAg Negative Chronic Hepatitis B Virus Infection Treated With Sebivo (Telbivudine) Using the 13C Methacetin Breath Test (BreathID®)

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.

Being tested
13C Methacetin Breath Test (BreathID)
Keywords
Patients with chronic HBeAg negative hepatitis B virus infection treated with Sebivo (Telbivudine)
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.

  • 13C Methacetin Breath Test (BreathID)Device

Study groups in NCT01204827
Study groupRoleWhat they receive
CHBV SebivoExperimentalNot described
Receives: Device: 13C Methacetin Breath Test (BreathID)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2010 (estimated)

Resources

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 2/3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01204827
Sponsor's protocol ID
CLDT600AIL02T
Status last verified
Jun 2011
First submitted
16 Sep 2010
Last updated
28 Aug 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing 13C Methacetin Breath Test (BreathID) in people with Chronic Hepatitis B, run by Hadassah Medical Organization at 1 site in Israel.

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 11 inclusion and 38 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: withdrawn, as of the sponsor's last update on 28 Aug 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 Israel. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was withdrawn before enrolling participants, so there are no results.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01204827.

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 28 Aug 2012.

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