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HBV-related Liver CirrhosisPhase 4NCT01799486

Telbivudine Renoprotective Effect in Patients With the HBV-related Liver Cirrhosis: a Randomized Controlled Trial

A Phase 4 study testing Telbivudine, Enecavir and Adefovir in people with HBV-related Liver Cirrhosis, run by Lin Bingliang.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Chronic hepatitis B virus (HBV) infection is a serious clinical problem because of its worldwide distribution and potential adverse outcome, including cirrhosis, which is a major cause of HBV related death. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
HBV-related Liver Cirrhosis
What is being tested?
Telbivudine, Enecavir and Adefovir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
No sites listed yet
Study dates
Feb 2013to Mar 2015
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Subjects meeting any of the following criteria must not be enrolled in the study
  • History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
  • Patient is pregnant or breastfeeding.
  • Subjects with non-HBV cirrhosis
  • Co-infection with HAV/HCV/HDV/ HIV
  • Patients who have previously been involved in a trial with telbivudine.
Show all 21Show fewer
  • 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 malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is 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，autoimmune hepatitis and so on. 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.
  • 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.
  • Kidney impairment due to non-HBV factors
  • Inability to comply with study requirements as determined by the study investigator
  • Patients with eGFR≤15 ml.min-1.1.73m2, who may need dialysis or renal transplantation

About this study

Chronic hepatitis B virus (HBV) infection is a serious clinical problem because of its worldwide distribution and potential adverse outcome, including cirrhosis, which is a major cause of HBV related death. Studies show the use of nucleot(s)ide analogs treatment can alleviate, even reverse the progress of HBV-related cirrhosis. In cirrhosis stage, some potential factors, including endocrine disorder, renin, aldosterone, vasopressin increasing, hepatitis B virus related nephritis, hepatorenal syndrome, may cause renal damage. With the exposure of NAs, adverse reports of rhabdomyolysis, renal dysfunction, and lactic acidosis are increasing. So when choosing NAs, the potential renal function impairment should be considered.

Recently, Gane, Xiaoxi Li have separately reported that Telbivudine can improve estimate of glomerular filtration rate (eGFR) of patients with chronic hepatitis B, while eGFR of patients with Lamivudine, adefovir and entecavir have a trend of decrease, which suggested Telbivudine may have renal protective effects. This effect on patients with HBV-related liver cirrhosis has not been studied, which is not clear now.

This study is a randomized controlled study to prospectively observe Telbivudine's effect on renal function, which aims to provide evidence in antiviral treatment for the patients with cirrhosis.

Being tested
Telbivudine, Enecavir, Adefovir
Keywords
Telbivudine, renoprotective efficacy, liver cirrhosis
Medical subject headings
Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelbivudineDrug

    Also called No.

    600 mg monotherapy supplied in film-coated tablets.

  • EnecavirDrug

    Also called No.

    0.5 mg monotherapy supplied in tablets.

  • AdefovirDrug

    Also called No.

    10 mg monotherapy supplied in tablets.

Study groups in NCT01799486
Study groupRoleWhat they receive
TelbivudineExperimentalTelbivudine,600mg/d,oral,100patients,2 years.
Receives: Drug: Telbivudine
AdefovirExperimentalAdefovir,10mg/d,oral,100 patients,2years.
Receives: Drug: Enecavir
EnecavirExperimentalEnecavir,0.5mg/d,oral,100 patients,2 year
Receives: Drug: Adefovir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of estimate of glomerular filtration rate (eGFR)* and Serum creatinine in week 4,12,18,24,48,72,96 in each Group.

    NO.

    Measured: up to 2years

Secondary outcomes (1)

  1. Liver function change (ALB/GLB, ALT/AST, TB) in each Group

    Measured: up to 2 years

Timeline

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

  1. First posted26 Feb 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionFeb 2013
  4. Study completionMar 2015 (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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01799486
Sponsor's protocol ID
Professor Bingliang Lin
Status last verified
Feb 2013
First submitted
19 Feb 2013
Last updated
26 Feb 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Telbivudine, Enecavir and Adefovir in people with HBV-related Liver Cirrhosis, run by Lin Bingliang.

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 0 inclusion and 21 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 26 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

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 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of estimate of glomerular filtration rate (eGFR)* and Serum creatinine in week 4,12,18,24,48,72,96 in each Group. (time frame: up to 2years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01799486.

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 26 Feb 2013.

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