Chronic Hepatitis CPhase 3ViZIRNCT02099604
Efficacy and Safety of the Combination Vitamin D With Standard of Care in Egyptian Patients With Untreated Chronic Hepatitis C
A Phase 3 study testing Vitamin D + Pegylated Interferon Alpha 2b + Ribavirin in people with Chronic Hepatitis C, run by ANRS, Emerging Infectious Diseases at 1 site in Egypt.
Trial summary
The purpose of this study is to show the superiority of a 4 weeks lead-in phase of Vitamin D followed by a 48 weeks combination of Vitamin D with PEG-IFN plus RBV in comparison with standard PEG-IFN + RBV in untreated Egyptian patients with chronic hepatitis C, on the sustained virological response (SVR) at 3 months… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Vitamin D + Pegylated Interferon Alpha 2b + Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2014to Apr 2014
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Common with National Program for Viral Hepatitis
- Age: 18 years to 60 years
- Positive HCV antibodies using a third generation test
- Detectable HCV RNA by PCR
- Liver biopsy showing chronic hepatitis with either a METAVIR score F1 with elevated liver enzymes or scores F2/F3
- Naïve to treatment with PEG-IFN and RBV
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- HBs antigen negative
- Prothrombin time ≥60 %, normal bilirubin, alpha-foeto protein < 3*normal range of the laboratory, anti-nuclear antibodies<1/160 Effective contraception during the treatment period; no breast-feeding
- Specific to the trial
- Prior approval from the Ministry of Health to be treated as part of the National Program with allocation to Peg-IFN α2b treatment
- Living <100 km from Cairo and able to come to the centre every week for the treatment
- Signed informed consent and willingness to participate in the trial
- Naïve to treatment with vitamin D (received vitamin D less than 30 consecutive days in the 3 months preceding inclusion)
- Biopsy slide validated by NHTMRI pathologist
Who cannot join
- Common with National program for Viral Hepatitis
- Serious co-morbid conditions such as severe hypertension, heart failure, significant coronary heart disease, poorly controlled diabetes (HbA1C>8%) , chronic obstructive pulmonary disease
- Major uncontrolled depressive illness
- Solid transplant organ (renal, heart, or lung)
- Untreated thyroid disease
- History of previous anti-HCV therapy
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- Body mass index (BMI) greater than 30 kg/m²
- Known human immunodeficiency virus (HIV) coinfection: although HIV testing will not be proposed or done, patients with known HIV coinfection will not be included in the trial
- Anti-HCV therapy contraindications:
- hypersensitivity to one of the two drugs (PEG-IFN, RBV)
- pregnancy or unwilling to comply with adequate contraception
- breast-feeding
- neutropenia (<1500/mm3)
- anaemia (<11g/dL for women ; <12g/dL for men)
- thrombocytopenia (<100,000/mm3)
- elevated creatinin (>1.5mg/dL)
- concomitant liver disease other than hepatitis C (immuno-active chronic hepatitis B, autoimmune hepatitis, alcoholic liver disease, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson disease)
- liver biopsy showing severe steatosis (>66%) and steatohepatitis; decompensated cirrhosis (Child Pugh>A); hepatocellular carcinoma, METAVIR score F4.
- TSH>5 mU/L
- Specific to the trial
- Patients allocated to Peg-IFN alpha 2a treatment
- Hypersensitivity to vitamin D
- Vitamin D contraindications:
- hypercalcaemia (fasting calcaemia >105 mg/L or 2.62 mmol/L)
- ratio calciuria / creatininuria (fasting ratio >1 mmol Ca/mmol creatinin)
- hyperphosphatemia (>1.5 mmol/L)
- calcium lithiasis
- patients being treated with thiazide diuretics (risk of hypercalcaemia with vitamin D treatment)
- patients being treated with glucocorticoïds (decrease in vitamin D efficacy)
- postmenopausal women treated by vitamin D and calcium for osteoporosis
- Treatment by vitamin D more than 30 consecutive days in the 3 months preceding inclusion in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of the Combination Vitamin D (Vit D), With Pegylated Interferon Alpha-2b (PEG-IFN)/Ribavirin (RBV) in Egyptian Patients With Untreated Chronic Hepatitis C: A Phase III Randomized Open-label Clinical Trial
The purpose of this study is to show the superiority of a 4 weeks lead-in phase of Vitamin D followed by a 48 weeks combination of Vitamin D with PEG-IFN plus RBV in comparison with standard PEG-IFN + RBV in untreated Egyptian patients with chronic hepatitis C, on the sustained virological response (SVR) at 3 months after end of treatment (week 60).
Read the detailed description
- Method: Phase III, randomized, open-label superiority clinical trial, among Egyptian patients with chronic hepatitis C.
- Treatment strategy: Vitamin D Arm: Vitamin D over a 4 weeks lead-in phase followed by Vitamin D in combination with PEG-INF plus RBV during 48 weeks. Standard of Care Arm: PEG-INF plus RBV during 48 weeks.
- Main outcome: Proportion of patients with Sustained Virological Response (SVR) as defined by HCV RNA below the detection limit based on quantitative PCR 12 weeks after stopping treatment.
- Sample Size: 520 patients (260 per arm)
- Enrollment period: 12 months
- Patient's participation duration: 62 weeks (SOC Arm), 66 weeks (Vit-D Arm)
- Statistical analysis:
The superiority of the vitamin D arm will be tested against the standard PEG IFN + RBV combination. 260 patients in each arm will give 80% power to document a 12% difference in the SVR rates between the experimental (Vitamin D) and the control (standard treatment) arms..
A futility analysis is planned for this study, in order to be able to interrupt the trial prematurely in case preliminary results show a lack of efficacy of vitamin D.
This analysis will be performed on half of the patients, thus 260 patients (130 patients per arm), on a week 12/14 week criterion (HCV RNA viral load at W12/W14).
- Conditions
- Chronic Hepatitis C
- Being tested
- Vitamin D + Pegylated Interferon Alpha 2b + Ribavirin
- Keywords
- Hepatitis C - Genotype 4, SVR (Sustained Virological Response), Vitamin D, Treatment Naïve
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D + Pegylated Interferon Alpha 2b + RibavirinDrug
Also called Vidrop, PegIntron, Rebetol
Vitamin D ARM: 28000UI/week during 4 weeks (lead in phase) then 28000 UI/week associated with PegIFN/RBV during 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | Vitamin D + Pegylated Interferon Alpha 2b + Ribavirin Receives: Drug: Vitamin D + Pegylated Interferon Alpha 2b + Ribavirin |
| Standard of Care | No intervention | Pegylated Interferon Alpha 2b + Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with Sustained Virological Response (SVR).
Proportion of patients with Sustained Virological Response (SVR) as defined by HCV RNA below the detection limit based on quantitative PCR 12 weeks after stopping treatment.
Measured: 60 Weeks after peg-IFN/RBV initiation
Secondary outcomes (6)
Rapid Virological Response (RVR)
HCV RNA at 4 weeks post initiation of combination therapy (PEG IFN + RBV)
Measured: 4 Weeks after peg-IFN/RBV initiation
Early Virological Response (EVR)
HCV RNA at 12 weeks post initiation of combination therapy
Measured: 12 Weeks after peg-IFN/RBV initiation
End of Treatment Response (ETR)
HCV RNA at end of treatment (week 48)
Measured: 48 Weeks after peg-IFN/RBV initiation
Normalization of ALT during treatment and 12 weeks after the end of treatment
Measured: From 2 Weeks after peg-IFN/RBV initiation to End of Follow-up (Week 60)
Incidence of serious adverse events (SAE) grade 3 and 4 (ANRS scale)
incidence of SAE leading to dosage reduction or treatment cessation, percentage of patients treated by EPO and G-CSF
Measured: From Lead-in phase (Week -4) to End of Follow-up (Week 60)
Evolution of FibroScan values between pre-inclusion and week 60
Measured: At Screening Visit 2 (S2) and at End of Follow-up (Week 60)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: Study objectives were considered as obsolete regarding the new AAD arrival
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.
- More trials run by ANRS, Emerging Infectious DiseasesThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Institut Pasteur
- Responsible party
- Sponsor
- Investigators
- Gamal Esmat, MD, PhD, Study chair, NHTMRI, Cairo, EgyptArnaud Fontanet, MD, PhD, Study chair, Institut Pasteur, Paris France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099604
- Sponsor's protocol ID
- ANRS 12226 ViZIR
- Acronym
- ViZIR
- Status last verified
- Jul 2017
- First submitted
- 24 Mar 2014
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Combination Vitamin D (Vit D), With Pegylated Interferon Alpha-2b (PEG-IFN)/Ribavirin (RBV) in Egyptian Patients With Untreated Chronic Hepatitis C: A Phase III Randomized Open-label Clinical Trial
- ClinicalTrials.gov ID
- NCT02099604
- Acronym / sponsor ID
- ViZIR / ANRS 12226 ViZIR
- Conditions
- Chronic Hepatitis C
- Keywords
- Hepatitis C - Genotype 4, SVR (Sustained Virological Response), Vitamin D, Treatment Naïve
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study objectives were considered as obsolete regarding the new AAD arrival
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Institut Pasteur
- Study start
- Apr 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 31 Mar 2014 (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 show the superiority of a 4 weeks lead-in phase of Vitamin D followed by a 48 weeks combination of Vitamin D with PEG-IFN plus RBV in comparison with standard PEG-IFN + RBV in untreated Egyptian patients with chronic hepatitis C, on the sustained virological response (SVR) at 3 months after end of treatment (week 60).
Detailed description
- Method: Phase III, randomized, open-label superiority clinical trial, among Egyptian patients with chronic hepatitis C.
- Treatment strategy: Vitamin D Arm: Vitamin D over a 4 weeks lead-in phase followed by Vitamin D in combination with PEG-INF plus RBV during 48 weeks. Standard of Care Arm: PEG-INF plus RBV during 48 weeks.
- Main outcome: Proportion of patients with Sustained Virological Response (SVR) as defined by HCV RNA below the detection limit based on quantitative PCR 12 weeks after stopping treatment.
- Sample Size: 520 patients (260 per arm)
- Enrollment period: 12 months
- Patient's participation duration: 62 weeks (SOC Arm), 66 weeks (Vit-D Arm)
- Statistical analysis:
The superiority of the vitamin D arm will be tested against the standard PEG IFN + RBV combination. 260 patients in each arm will give 80% power to document a 12% difference in the SVR rates between the experimental (Vitamin D) and the control (standard treatment) arms..
A futility analysis is planned for this study, in order to be able to interrupt the trial prematurely in case preliminary results show a lack of efficacy of vitamin D.
This analysis will be performed on half of the patients, thus 260 patients (130 patients per arm), on a week 12/14 week criterion (HCV RNA viral load at W12/W14).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Drug: Vitamin D + Pegylated Interferon Alpha 2b + RibavirinVitamin D + Pegylated Interferon Alpha 2b + Ribavirin |
| Standard of Care | No intervention | –Pegylated Interferon Alpha 2b + Ribavirin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Common with National Program for Viral Hepatitis
- Age: 18 years to 60 years
- Positive HCV antibodies using a third generation test
- Detectable HCV RNA by PCR
- Liver biopsy showing chronic hepatitis with either a METAVIR score F1 with elevated liver enzymes or scores F2/F3
Key exclusion criteria (31 listed)
- Common with National program for Viral Hepatitis
- Serious co-morbid conditions such as severe hypertension, heart failure, significant coronary heart disease, poorly controlled diabetes (HbA1C>8%) , chronic obstructive pulmonary disease
- Major uncontrolled depressive illness
- Solid transplant organ (renal, heart, or lung)
- Untreated thyroid disease
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 |
|---|---|---|
| Vitamin D + Pegylated Interferon Alpha 2b + RibavirinAlso: Vidrop, PegIntron, RebetolVitamin D ARM: 28000UI/week during 4 weeks (lead in phase) then 28000 UI/week associated with PegIFN/RBV during 48 weeks | Drug | Vitamin D |
Primary outcome
Proportion of patients with Sustained Virological Response (SVR).
Time frame: 60 Weeks after peg-IFN/RBV initiation
Proportion of patients with Sustained Virological Response (SVR) as defined by HCV RNA below the detection limit based on quantitative PCR 12 weeks after stopping treatment.
6 secondary outcomes
Rapid Virological Response (RVR)
Time frame: 4 Weeks after peg-IFN/RBV initiation
Early Virological Response (EVR)
Time frame: 12 Weeks after peg-IFN/RBV initiation
End of Treatment Response (ETR)
Time frame: 48 Weeks after peg-IFN/RBV initiation
Normalization of ALT during treatment and 12 weeks after the end of treatment
Time frame: From 2 Weeks after peg-IFN/RBV initiation to End of Follow-up (Week 60)
Incidence of serious adverse events (SAE) grade 3 and 4 (ANRS scale)
Time frame: From Lead-in phase (Week -4) to End of Follow-up (Week 60)
Evolution of FibroScan values between pre-inclusion and week 60
Time frame: At Screening Visit 2 (S2) and at End of Follow-up (Week 60)
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 12 Jul 2017.
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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.
Gamal Esmat, MD, PhD study chair
NHTMRI, Cairo, Egypt
Arnaud Fontanet, MD, PhD study chair
Institut Pasteur, Paris France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D + Pegylated Interferon Alpha 2b + Ribavirin in people with Chronic Hepatitis C, run by ANRS, Emerging Infectious Diseases at 1 site in Egypt.
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 14 inclusion and 31 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 12 Jul 2017. 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 Egypt. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Proportion of patients with Sustained Virological Response (SVR). (time frame: 60 Weeks after peg-IFN/RBV initiation). 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 12 Jul 2017.