Compensated Chronic Hepatitis BPhase 4NCT00862706

Efficacy of Telbivudine in Blacks/African Americans and Hispanics/Latinos With Compensated Chronic Hepatitis B During 52 Weeks

A Phase 4 study testing Telbivudine/LDT600A in people with Compensated Chronic Hepatitis B, run by Novartis Pharmaceuticals at 6 sites in 2 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

The purpose of this study is to investigate the efficacy of telbivudine in Blacks/African Americans and Hispanics/Latinos with compensated chronic hepatitis B during 52 weeks of treatment Read more about this study

Who is it for?: Ages 16 to 70 years
Conditions the study is for: Compensated Chronic Hepatitis B
What is being tested?: Telbivudine/LDT600A
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 6 sitesin 2 countries
Study dates: Apr 2009to Apr 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 16 to 70 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients must give written informed consent before any assessment is performed.
Male or female, 16 to 70 years of age.
Black/African American race and/or Hispanic/Latino ethnicity
Documented compensated chronic hepatitis B defined by all of the following:
Clinical history compatible with compensated chronic hepatitis B.
Positive serum HBsAg at least 6 months prior to study entry

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HBeAg-positive or HBeAg-negative at the Screening visit.
Detectable serum HBsAg at the Screening visit.
Serum ALT level > or = 1.3 and <10x ULN at the Screening visit.
Serum HBV DNA level > or = 5 log10 copies/mL as determined by the COBAS™ Amplicor HBV PCR assay at the central study laboratory
Willing and able to comply with the study drug regimen and all other study requirements.

Who cannot join

Subject is pregnant or breastfeeding. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-HCG) at Screening.
Subject is of reproductive potential (men and women) and unwilling to use double barrier method of contraception. It is required that double barrier method of contraception be used (i.e. condom with spermicide or diaphragm with spermicide) by subjects of reproductive potential (men and women) regardless of whether a hormonal agent is also used as a method of contraception.
Subject is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV), or human immunodeficiency virus (HIV-1 or HIV-2). Patients will be tested for antibodies to HCV, HDV, and HIV at the Screening visit in assessments performed at the central laboratory.
Subject previously received lamivudine, adefovir dipivoxil, entecavir, telbivudine or an investigational anti-HBV nucleoside or nucleotide analog at any time. Precluded therapies include, but are not limited to, the following: any previous exposure to lamivudine, adefovir or other PMEA analogs (tenofovir, MCC-478), lobucavir, entecavir, emtricitabine (FTC), L-FMAU, L-Fd4C, or other investigational anti-HBV nucleosides/nucleotides.
Subject has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before Screening for this study. Precluded therapies include, but are not limited to, interferon agents (alpha-, beta- or gamma-interferons), thymosin, IL-12, or other putative systemic immunomodulators.
Subject has a history of or clinical signs/symptoms of hepatic decompensation such as ascites, variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis.

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Subject has a medical condition that requires prolonged or frequent use of systemic acyclovir or famciclovir (e.g., for recurrent herpes virus infections, etc). Prolonged use means episodic treatment with these agents for periods exceeding 10 days every 3 months, or chronic suppressive therapy.
Subject has a 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. In patients with such findings, HCC must be ruled-out prior to Screening for the present study.
Subject has one or more additional known primary or secondary causes of liver disease, other than hepatitis B (e.g., alcoholism, 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, etc.). Gilbert's syndrome and Dubin-Johnson syndrome, two benign disorders associated with low-grade hyberbilirubinemia, will not exclude patients from participation in this trial.
Subject has a history of clinical or laboratory evidence of pancreatitis or demonstrates a clinical or laboratory course consistent with pancreatitis within 12 weeks of study screening.
Subject is currently abusing alcohol or illicit drugs, or has a history of alcohol abuse or illicit substance abuse within the preceding two years. For the purposes of the present study, alcohol abuse is arbitrarily defined as frequent consumption of alcoholic beverages with an average daily intake of more than 40g of ethanol or 3 beers or the equivalent. Patients currently on methadone maintenance treatment programs are NOT eligible for this study due to potential interference with the study evaluations.
Subject has 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, etc).
Subject 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 (e.g., concurrent malignancy; history of unstable angina or repeated myocardial infarction; uncontrolled asthma or diabetes; unstable thyroid disease or other significant hormonal condition; frequent or uncontrolled seizure disorder; severe psychiatric disorder requiring psychotropic medication; active tuberculosis, pneumonia, or other severe infection under current treatment; lives in a country other than that of the investigative site; or has other medical or social circumstances likely to interfere with the schedule of evaluations).
A history of treated malignancy (other than hepatocellular carcinoma) is allowable if the subject's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding 3 years.
Subject has a history of myopathy, myositis, or persistent muscle weakness or peripheral neuropathy (polyneuropathy).
Subject has a known history of allergy to nucleoside analogues.
Subject is enrolled or plans to enroll in another clinical trial of an investigational agent while participating in this study.
Subject has any of the following laboratory values at Screening:
Absolute neutrophil count (ANC) <1500/mm3
Hemoglobin <11.0 g/dL (men) or <10.0 g/dL (women)
Platelet count <75,000/mm3
ALT (SGPT) >10x ULN
Serum creatinine >1.5x ULN
Total bilirubin >2.0x mg/dL
Prothrombin time >2.0 seconds above ULN
Serum amylase or lipase > or = 1.5x ULN
Serum albumin <3.3 g/dL
Serum alpha-fetoprotein (AFP) >50 ng/mL. If AFP is >50 ng/mL, the subject must have an imaging study of the liver demonstrating no evidence of tumor within 60 days prior to study entry.
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

6 sites in 2 countries.

Country

City, postcode or hospital

6 sites in 2 countries

United States5 sites

Hepatobiliary Associates of New York
Bayside, New York, 11358
Tufts Medical Center
Boston, Massachusetts, 02111
Rush University Medical Center
Chicago, Illinois, 60612
Liver Associates of Texas
Houston, Texas, 77030
Liver Specialist of Texas
Houston, Texas, 77030

Other trials in United States

Puerto Rico1 site

Fundacion de Investigacion de Diego
San Juan, 00909

Other trials in Puerto Rico

About this study

Official title: An Open-label, Single-arm, Multicenter, Study of Telbivudine in Nucleos(t)Ide-naïve Subjects of Black/African American or Hispanic/Latino Origin With Compensated Chronic Hepatitis B Virus (HBV) Infection

The purpose of this study is to investigate the efficacy of telbivudine in Blacks/African Americans and Hispanics/Latinos with compensated chronic hepatitis B during 52 weeks of treatment

Conditions: Compensated Chronic Hepatitis B
Being tested: Telbivudine/LDT600A
Keywords: Chronic HBV

What participants receive

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

Telbivudine/LDT600ADrug
Oral once daily

Study groups in NCT00862706
Study group	Role	What they receive
A	Experimental	Not described Receives: Drug: Telbivudine/LDT600A

What is being measured

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

non detectable HBV DNA level
Measured: week 52

Secondary outcomes (6)

Mean and median reduction in HBV DNA
Measured: weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 52 or premature D/C
Mean and median reduction from Baseline in absolute ALT level
Measured: weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 52 or premature D/C
Proportion of patients with ALT normalization
Measured: weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 52 or premature D/C
Proportion of patients with non-detectable serum HBV DNA
Measured: week 24
of patients with HBeAg loss in subjects who were HBeAg positive at Baseline
Measured: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 52 or premature D/C
Proportion of patients with HBeAg seroconversion in subjects who were HBeAg positive at Baseline
Measured: 2, 4, 8, 12, 16, 24, 32, 40, 48 and 52 or premature D/C

Timeline

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

Apr 2009Apr 2011

First posted17 Mar 2009 (estimated)
Study startApr 2009
Primary completionApr 2011
Study completionApr 2011

Why it stopped: Stopped with Patients

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Compensated Chronic Hepatitis BStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00862706
Sponsor's protocol ID: CLDT600AUS06
Status last verified: Sep 2016
First submitted: 16 Mar 2009
Last updated: 23 Sep 2016
Results posted: No

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Single-arm, Multicenter, Study of Telbivudine in Nucleos(t)Ide-naïve Subjects of Black/African American or Hispanic/Latino Origin With Compensated Chronic Hepatitis B Virus (HBV) Infection
ClinicalTrials.gov ID: NCT00862706
Acronym / sponsor ID: CLDT600AUS06
Conditions: Compensated Chronic Hepatitis B
Keywords: Chronic HBV
Phase: Phase 4
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Stopped with Patients
Enrolment: 0 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 17 Mar 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to investigate the efficacy of telbivudine in Blacks/African Americans and Hispanics/Latinos with compensated chronic hepatitis B during 52 weeks of treatment

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
A	Experimental	Drug: Telbivudine/LDT600A

Who may qualify

Ages: 16 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (11 listed)

Patients must give written informed consent before any assessment is performed.
Male or female, 16 to 70 years of age.
Black/African American race and/or Hispanic/Latino ethnicity
Documented compensated chronic hepatitis B defined by all of the following:
Serum HBV DNA level > or = 5 log10 copies/mL as determined by the COBAS™ Amplicor HBV PCR assay at the central study laboratory

Key exclusion criteria (29 listed)

Subject is pregnant or breastfeeding. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-HCG) at Screening.
Subject is of reproductive potential (men and women) and unwilling to use double barrier method of contraception. It is required that double barrier method of contraception be used (i.e. condom with spermicide or diaphragm with spermicide) by subjects of reproductive potential (men and women) regardless of whether a hormonal agent is also used as a method of contraception.
Subject is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV), or human immunodeficiency virus (HIV-1 or HIV-2). Patients will be tested for antibodies to HCV, HDV, and HIV at the Screening visit in assessments performed at the central laboratory.
Subject previously received lamivudine, adefovir dipivoxil, entecavir, telbivudine or an investigational anti-HBV nucleoside or nucleotide analog at any time. Precluded therapies include, but are not limited to, the following: any previous exposure to lamivudine, adefovir or other PMEA analogs (tenofovir, MCC-478), lobucavir, entecavir, emtricitabine (FTC), L-FMAU, L-Fd4C, or other investigational anti-HBV nucleosides/nucleotides.
Subject has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before Screening for this study. Precluded therapies include, but are not limited to, interferon agents (alpha-, beta- or gamma-interferons), thymosin, IL-12, or other putative systemic immunomodulators.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Telbivudine/LDT600AOral once daily	Drug	A

Primary outcome

non detectable HBV DNA level
Time frame: week 52

6 secondary outcomes

Mean and median reduction in HBV DNA
Time frame: weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 52 or premature D/C
Mean and median reduction from Baseline in absolute ALT level
Time frame: weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 52 or premature D/C
Proportion of patients with ALT normalization
Time frame: weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 52 or premature D/C
Proportion of patients with non-detectable serum HBV DNA
Time frame: week 24
of patients with HBeAg loss in subjects who were HBeAg positive at Baseline
Time frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 52 or premature D/C
Proportion of patients with HBeAg seroconversion in subjects who were HBeAg positive at Baseline
Time frame: 2, 4, 8, 12, 16, 24, 32, 40, 48 and 52 or premature D/C

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

6 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Telbivudine/LDT600A in people with Compensated Chronic Hepatitis B, run by Novartis Pharmaceuticals at 6 sites in 2 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 11 inclusion and 29 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 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Puerto Rico. 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 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.

What does the primary outcome measure?

non detectable HBV DNA level (time frame: 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 NCT00862706.

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 23 Sep 2016.