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Hepatitis B, ChronicPhase 4NCT00651209

A Single-arm Study Evaluating the Efficacy and Safety of Telbivudine With or Without add-on Tenofovir in Adults With HBeAg-positive Chronic Hepatitis B (CHB)

A Phase 4 study testing Tenofovir in people with Hepatitis B, Chronic, run by Novartis Pharmaceuticals at 4 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the use of telbivudine for patients with HBeAg-positive CHB with an option to intensify treatment at Week 24 by adding tenofovir for patients who do not achieve HBV DNA non-detectability. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis B, Chronic
What is being tested?
Tenofovir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
4 sitesin 4 countries
Study dates
Feb 2008to Dec 2011
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, at least 18 years of age.
  • Documented HBeAg positive CHB defined by all of the following:
  • Clinical history compatible with CHB
  • Detectable serum HBsAg at the Screening visit and at least 6 months prior
  • HBeAg positive at the Screening visit
  • HBeAb negative at the Screening visit
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  • Serum HBV DNA level ≥ 5 log10 copies/mL, as determined by the COBAS Amplicor HBV PCR assay (LLOD = 300 copies / mL) at the central study laboratory at Screening visit
  • Evidence of chronic liver inflammation, documented by previous history of elevated serum ALT and /or AST levels (at least two elevated ALT or AST values spanning six months or more, documented in available records) with or without prior liver biopsy that is consistent with CHB
  • For patients with cirrhosis, clinical history compatible with compensated liver disease
  • Elevated serum ALT level (1.3 - 10 x ULN) at the Screening visit
  • 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

  • Patients will be excluded from the study for any of the following:
  • History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures.
  • 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 beta-human chorionic gonadotropin (β-HCG) during Screening.
  • Is a male who is 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 and men who have been sterilized (vasectomy) or whose partners have been sterilized by surgical bilateral oophorectomy with or without hysterectomy, bilateral tubal ligation or other means, 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.
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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 12 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.
  • Patient has a medical condition that requires prolonged or frequent use of systemic acyclovir or famciclovir.
  • 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 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. Note: 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. Please refer to Appendix 3.
  • Patient has a medical condition that requires frequent or prolonged use of systemic corticosteroids, although topical and inhaled corticosteroids are allowed.
  • Patient has a history of clinical and laboratory evidence of chronic renal insufficiency defined as an estimated serum creatinine clearance < 50 mL/min using the Cockcroft-Gault method.
  • 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)

Trial locations and contacts

4 sites in 4 countries.

4 sites in 4 countries

Argentina1 site

  • Novartis

    Buenos Aires

Other trials in Argentina

Brazil1 site

  • Novartis

    São Paulo

Other trials in Brazil

Germany1 site

  • Novartis

    Frankfurt

Other trials in Germany

Thailand1 site

  • Novartis

    Bangkok

Other trials in Thailand

About this study

Official title: A Single-arm, Multinational, Two Year Study Evaluating the Efficacy and Safety of lead-in Telbivudine for 24 Weeks With or Without Tenofovir Treatment Intensification in Adult Patients With HBeAg-positive Chronic Hepatitis B.

This study will evaluate the use of telbivudine for patients with HBeAg-positive CHB with an option to intensify treatment at Week 24 by adding tenofovir for patients who do not achieve HBV DNA non-detectability.

Being tested
Tenofovir
Keywords
Hepatitis B, chronic, Telbivudine, Tenofovir, Roadmap Concept
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.

  • TenofovirDrug

    Also called Sebivo, Tyzeka, Viread

    All patients receive 600 mg/day, oral telbivudine for 24 weeks. Patients with non-detectable HBV DNA continue 600 mg/day, oral telbivudine for the remaining treatment period (Sub-group 1) Patients with detectable HBV DNA receive 300 mg/day, oral tenofovir plus 600 mg/day, oral telbivudine for the remaining treatment period (Sub-group 2)

Study groups in NCT00651209
Study groupRoleWhat they receive
1ExperimentalSub-group 1- continue telbivudine if HBV DNA non-detectable at week 24 Sub-group 2- tenofovir added to telbivudine in patients if HBV DNA detectable at week 24
Receives: Drug: Tenofovir

What is being measured

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

  1. The primary objective of the study is to determine if telbivudine early non-responders can achieve an antiviral response with the addition of tenofovir.

    Measured: at week 52

Secondary outcomes (1)

  1. To estimate the rate of virologic breakthrough up to week 48 and week 104 To assess the rate of treatment-emergent genotypically confirmed HBV resistance associated with viral breakthrough up to weeks 48 and 104 and 104

    Measured: at week 52 and 104

Timeline

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

  1. First posted2 Apr 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionDec 2011

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00651209
Sponsor's protocol ID
CLDT600A2410
Status last verified
Mar 2014
First submitted
18 Mar 2008
Last updated
7 Mar 2014
Results posted
No

Publications

  • Piratvisuth T, Komolmit P, Tanwandee T, Sukeepaisarnjaroen W, Chan HL, Pessoa MG, Fassio E, Ono SK, Bessone F, Daruich J, Zeuzem S, Cheinquer H, Pathan R, Dong Y, Trylesinski A. 52-week efficacy and safety of telbivudine with conditional tenofovir intensification at week 24 in HBeAg-positive chronic hepatitis B. PLoS One. 2013;8(2):e54279. doi: 10.1371/journal.pone.0054279. Epub 2013 Feb 4.

    PubMed 23390496

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tenofovir in people with Hepatitis B, Chronic, run by Novartis Pharmaceuticals at 4 sites in 4 countries.

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 12 inclusion and 24 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: finished, as of the sponsor's last update on 7 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Argentina, Brazil, Germany, Thailand. 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The primary objective of the study is to determine if telbivudine early non-responders can achieve an antiviral response with the addition of tenofovir. (time frame: at week 52). 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 NCT00651209, which also lists 1 linked publication.

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 7 Mar 2014.

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