Chronic Hepatitis CNCT01151397
Does 3 Months Therapy With Vitamin D + Peg + Ribavirin Improve Sustained Virologic Response (SVR) in Genotype 2, 3 Chronic Hepatitis C Patients?
A study testing Peg + Vitamin D + Ribavirin and Peg + Ribavirin in people with Chronic Hepatitis C, run by Ziv Hospital at 1 site in Israel.
Trial summary
Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2,3. Studies rarely address the issues of improving host factors. The current study examines 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Peg + Vitamin D + Ribavirin and Peg + Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2011to Jul 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 years of age
- chronic genotype 2,3 HCV infection
- treatment Naive negative sero for HBV, HDV and HIV viral infections
- absolute neutrophil count of >1500 per cubic millimeter
- a platelet count of >90,000 per cubic millimeter normal hemoglobin level
Who cannot join
- decompensated liver disease (cirrhosis with CP score >9)
- another cause of clinically significant liver disease hepato cellular carcinoma
- psychiatric Disorder
- chronic heart failure
- pregnant women
- uncontrolled diabetes with retinopathy Arrhythmia Active CAD
- positive sero for HBV, HDV and HIV viral infections or other autoimmune liver disease
Trial locations and contacts
1 site in 1 country.
Israel1 site
Ziv medical center liver unit
Safed, Israel, 13100
Nimer Assy, +972-46828445, assy.n@ziv.health.gov.il
About this study
Official title: Does 3 Months Therapy With Vitamin D + Peg + Ribavirin Improve SVR in Genotype 2,3 Chronic Hepatitis C Patients?
Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2,3. Studies rarely address the issues of improving host factors. The current study examines
- Does 3 months therapy with Vitamin D+ Peg + Ribavirin could improve viral response and shorten treatment duration (from 24 weeks to 12 weeks)
- whether Vitamin D levels predicts negative treatment outcome.
Read the detailed description
Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2, 3. Studies rarely address the issues of improving host factors. The current study examines whether adding vitamin D, a potent immunomodulator, for 3 months therapy could improve viral response. The working hypothesis is that 3 months therapy with Vitamin D + Peg + Ribavirin significantly improves RVR, EVR, and SVR.
- Conditions
- Chronic Hepatitis C
- Being tested
- Peg + Vitamin D + Ribavirin, Peg + Ribavirin
- Keywords
- SVR, VITAMIN D, Hepatitis C, Genotype 2,3, Naive, RVR
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peg + Vitamin D + RibavirinDrug
Peg+ Vitamin D+ Ribavirin for 3 months
Peg + RibavirinDrug
Peg+ Ribavirin for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Peg + Vitamin D + Ribavirin | Active comparator | Peg + Vitamin D + Ribavirin for 3 months Receives: Drug: Peg + Vitamin D + Ribavirin |
| Peg + Ribavirin | Active comparator | Peg + Ribavirin for 6 months Receives: Drug: Peg + Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
sustained virologic response (SVR)rate
the SVR rate data will be collected and compared for 2 groups
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2010 (estimated)
- Study startAug 2011
- Primary completionFeb 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151397
- Sponsor's protocol ID
- Genotype 2,3 HCV +Vitamin D
- Status last verified
- Jun 2010
- First submitted
- 16 Jun 2010
- Last updated
- 28 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does 3 Months Therapy With Vitamin D + Peg + Ribavirin Improve SVR in Genotype 2,3 Chronic Hepatitis C Patients?
- ClinicalTrials.gov ID
- NCT01151397
- Acronym / sponsor ID
- Genotype 2,3 HCV +Vitamin D
- Conditions
- Chronic Hepatitis C
- Keywords
- SVR, VITAMIN D, Hepatitis C, Genotype 2,3, Naive, RVR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Aug 2011
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 28 Jun 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.
Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2,3. Studies rarely address the issues of improving host factors. The current study examines
- Does 3 months therapy with Vitamin D+ Peg + Ribavirin could improve viral response and shorten treatment duration (from 24 weeks to 12 weeks)
- whether Vitamin D levels predicts negative treatment outcome.
Detailed description
Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2, 3. Studies rarely address the issues of improving host factors. The current study examines whether adding vitamin D, a potent immunomodulator, for 3 months therapy could improve viral response. The working hypothesis is that 3 months therapy with Vitamin D + Peg + Ribavirin significantly improves RVR, EVR, and SVR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peg + Vitamin D + Ribavirin | Active comparator | Drug: Peg + Vitamin D + RibavirinPeg + Vitamin D + Ribavirin for 3 months |
| Peg + Ribavirin | Active comparator | Drug: Peg + RibavirinPeg + Ribavirin for 6 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 to 65 years of age
- chronic genotype 2,3 HCV infection
- treatment Naive negative sero for HBV, HDV and HIV viral infections
- absolute neutrophil count of >1500 per cubic millimeter
- a platelet count of >90,000 per cubic millimeter normal hemoglobin level
Key exclusion criteria (7 listed)
- decompensated liver disease (cirrhosis with CP score >9)
- another cause of clinically significant liver disease hepato cellular carcinoma
- psychiatric Disorder
- chronic heart failure
- pregnant women
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 |
|---|---|---|
| Peg + Vitamin D + RibavirinPeg+ Vitamin D+ Ribavirin for 3 months | Drug | Peg + Vitamin D + Ribavirin |
| Peg + RibavirinPeg+ Ribavirin for 6 months | Drug | Peg + Ribavirin |
Primary outcome
sustained virologic response (SVR)rate
Time frame: 24 weeks
the SVR rate data will be collected and compared for 2 groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peg + Vitamin D + Ribavirin and Peg + Ribavirin in people with Chronic Hepatitis C, run by Ziv Hospital 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 5 inclusion and 7 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 28 Apr 2011. 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.
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 (+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?
sustained virologic response (SVR)rate (time frame: 24 weeks). 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 28 Apr 2011.