Hepatitis B VirusNCT01083251
The Beneficial Effect of Vitamin D Supplement to Peg Interferon Alpha 2a or to Telbivudine Monotherapy in Patients With Chronic Hepatitis B Virus (HBV) Infection
A study testing Peginterferon + Vitamin D, Peginterferon and Sebivo in people with Hepatitis B Virus, run by Ziv Hospital at 2 sites in Israel.
Trial summary
Abstract Telbivudine is a potent inhibitor of HBV but, due to a low genetic barrier to resistance, a high incidence of resistance has been observed in patients with high baseline levels of replication and in those with detectable HBV DNA after 24 weeks of therapy (A1). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B Virus
- What is being tested?
- Peginterferon + Vitamin D, Peginterferon and Sebivo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesIsrael
- Study dates
- Mar 2010to Dec 2012
- Phase
- Interventional
- 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
- patients were eligible if they had been HBsAg positive for at least 6 months,
- patients were HBeAg positive or negative,
- patients had increased serum ALT levels between 1 and 10 times the upper limit of normal (ULN),
- patients had serum HBV-DNA levels greater than 1.0 x 10E5 copies/mL (2.0 X 10E4 IUmL), and
- patients had findings on a liver biopsy within the preceding 12 months that were consistent with the presence of chronic hepatitis B.
Who cannot join
- decompensated liver disease,
- antiviral therapy within 6 months before randomization,
- viral co-infections (hepatitis C virus, hepatitis delta virus, or human immunodeficiency virus), or
- pre-existent neutropenia or thrombocytopenia.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Liver clinic
Safed, 13100
nimer assy, MD
- Not yet recruiting
Ziv medical center liver unit
Safed, Israel, 13100
About this study
Official title: The Beneficial Effect of Vitamin D Supplement to Peg Interferon Alpha 2a or to Telbivudine Monotherapy in Patients With Chronic HBV Viral Infection
Abstract
Telbivudine is a potent inhibitor of HBV but, due to a low genetic barrier to resistance, a high incidence of resistance has been observed in patients with high baseline levels of replication and in those with detectable HBV DNA after 24 weeks of therapy (A1). Telbivudine might be used in patients with good predictors of response (HBV DNA <2 X 106 IU/ ml, i.e. approximately 107 copies/ ml, or 6.3 log 10 IU/ ml at baseline) with verification of HBV DNA suppression below detection in real time PCR assay at 24 weeks.(EASL Guidelines for HBV 2009) The therapy of Pegylated-interferon-alpha-2a is considered as the standard of care for patients with chronic hepatitis b viral infection. However, recent study by Buster et al showed that a sustained viral response (SVR less than 2000 iu.ml at 6 months after treatment)) is obtained in 8 % of patients with genotype D, 30% genotype A, and 20-25% genotypes B or C (47). Vitamin D is a potent immune-modulator; and has been shown to improve SVR in combination with peg interferone in patients with chronic HCV viral infection (48). The impact of vitamin D on virologic response rates of interferon-based treatment of CHB is unknown. The aim of this study therefore was to assess whether Vitamin D, added to the conventional peg therapy in CHB, or to nucleotide analogues could improve the treatment efficacy
- Conditions
- Hepatitis B Virus
- Being tested
- Peginterferon + Vitamin D, Peginterferon, Sebivo, entecavir+ vitamin d
- Keywords
- HBV, VITAMIN D, PEGITERFERON, Telbivudine
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon + Vitamin DDrug
180 mcg/week + 400 IUX2/day
PeginterferonDrug
180 mcg/week
SebivoDrug
Telbivudine 600 mg daily
entecavir+ vitamin dDrug
entecavir 1 mg daily+ vitamin d
| Study group | Role | What they receive |
|---|---|---|
| Peg + Vitamin D | Experimental | Treatment arm with vitamin D will be treated first with vitamin D supplement for 3 months before the initiation of antiviral therapy. Vitamin D levels will be measures at baseline and three months after. The serum vitamin D-25-OH levels should be > 32 ng/ml before the initiation of antiviral treatment). HBV DNA levels will be also measure at baseline and after 3 months of mono therapy with vitamin D Receives: Drug: Peginterferon + Vitamin D |
| Peginterferon | Active comparator | Not described Receives: Drug: Peginterferon |
| Sebivo | Active comparator | Nucleotide Analog Telbivudine 600 mg daily Receives: Drug: Sebivo |
| entecavir + vitamin d | Active comparator | baraclude 1 mg x1/ day + vitamin d Receives: Drug: entecavir+ vitamin d |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment efficacy
The primary end point will be sustained viral response which was defined as clearance of HBeAg from serum and HBV DNA less than 10,000 copies/mL (2000 IU/mL) at 6 months after treatment. HBsAg titre during treatment and at 6 months follow up will be measured also (ROCH or Abott Kit).
Measured: 120 weeks
histologic response
Another primary endpoint will be histologic response (reduction of at least two points without fibrosis worsening in the total score on the Histological Activity Index).
Measured: 120 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionFeb 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B VirusStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083251
- Sponsor's protocol ID
- 004-10
- Status last verified
- Mar 2010
- First submitted
- 3 Mar 2010
- Last updated
- 19 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Beneficial Effect of Vitamin D Supplement to Peg Interferon Alpha 2a or to Telbivudine Monotherapy in Patients With Chronic HBV Viral Infection
- ClinicalTrials.gov ID
- NCT01083251
- Acronym / sponsor ID
- 004-10
- Conditions
- Hepatitis B Virus
- Keywords
- HBV, VITAMIN D, PEGITERFERON, Telbivudine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Mar 2010
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 9 Mar 2010 (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.
Abstract
Telbivudine is a potent inhibitor of HBV but, due to a low genetic barrier to resistance, a high incidence of resistance has been observed in patients with high baseline levels of replication and in those with detectable HBV DNA after 24 weeks of therapy (A1). Telbivudine might be used in patients with good predictors of response (HBV DNA <2 X 106 IU/ ml, i.e. approximately 107 copies/ ml, or 6.3 log 10 IU/ ml at baseline) with verification of HBV DNA suppression below detection in real time PCR assay at 24 weeks.(EASL Guidelines for HBV 2009) The therapy of Pegylated-interferon-alpha-2a is considered as the standard of care for patients with chronic hepatitis b viral infection. However, recent study by Buster et al showed that a sustained viral response (SVR less than 2000 iu.ml at 6 months after treatment)) is obtained in 8 % of patients with genotype D, 30% genotype A, and 20-25% genotypes B or C (47). Vitamin D is a potent immune-modulator; and has been shown to improve SVR in combination with peg interferone in patients with chronic HCV viral infection (48). The impact of vitamin D on virologic response rates of interferon-based treatment of CHB is unknown. The aim of this study therefore was to assess whether Vitamin D, added to the conventional peg therapy in CHB, or to nucleotide analogues could improve the treatment efficacy
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Peg + Vitamin D | Experimental | Drug: Peginterferon + Vitamin DTreatment arm with vitamin D will be treated first with vitamin D supplement for 3 months before the initiation of antiviral therapy. Vitamin D levels will be measures at baseline and three months after. The serum vitamin D-25-OH levels should be > 32 ng/ml before the initiation of antiviral treatment). HBV DNA levels will be also measure at baseline and after 3 months of mono therapy with vitamin D |
| Peginterferon | Active comparator | Drug: Peginterferon |
| Sebivo | Active comparator | Drug: SebivoNucleotide Analog Telbivudine 600 mg daily |
| entecavir + vitamin d | Active comparator | Drug: entecavir+ vitamin dbaraclude 1 mg x1/ day + vitamin d |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients were eligible if they had been HBsAg positive for at least 6 months,
- patients were HBeAg positive or negative,
- patients had increased serum ALT levels between 1 and 10 times the upper limit of normal (ULN),
- patients had serum HBV-DNA levels greater than 1.0 x 10E5 copies/mL (2.0 X 10E4 IUmL), and
- patients had findings on a liver biopsy within the preceding 12 months that were consistent with the presence of chronic hepatitis B.
Key exclusion criteria (4 listed)
- decompensated liver disease,
- antiviral therapy within 6 months before randomization,
- viral co-infections (hepatitis C virus, hepatitis delta virus, or human immunodeficiency virus), or
- pre-existent neutropenia or thrombocytopenia.
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 |
|---|---|---|
| Peginterferon + Vitamin D180 mcg/week + 400 IUX2/day | Drug | Peg + Vitamin D |
| Peginterferon180 mcg/week | Drug | Peginterferon |
| SebivoTelbivudine 600 mg daily | Drug | Sebivo |
| entecavir+ vitamin dentecavir 1 mg daily+ vitamin d | Drug | entecavir + vitamin d |
Primary outcome
treatment efficacy
Time frame: 120 weeks
The primary end point will be sustained viral response which was defined as clearance of HBeAg from serum and HBV DNA less than 10,000 copies/mL (2000 IU/mL) at 6 months after treatment. HBsAg titre during treatment and at 6 months follow up will be measured also (ROCH or Abott Kit).
histologic response
Time frame: 120 WEEKS
Another primary endpoint will be histologic response (reduction of at least two points without fibrosis worsening in the total score on the Histological Activity Index).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2011.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peginterferon + Vitamin D, Peginterferon and Sebivo in people with Hepatitis B Virus, run by Ziv Hospital at 2 sites 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 5 inclusion and 4 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 19 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Contact Assy Nimer, MD (+97246828445, ASSY.N@ZIV.HEALTH.GOV.IL), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment efficacy (time frame: 120 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2011.