Efficacy and Safety of the Combination Vitamin D With Standard of Care in Egyptian Patients With Untreated Chronic Hepatitis C (ViZIR)
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|ClinicalTrials.gov Identifier: NCT02099604|
Recruitment Status : Withdrawn (Study objectives were considered as obsolete regarding the new AAD arrival)
First Posted : March 31, 2014
Last Update Posted : July 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C||Drug: Vitamin D + Pegylated Interferon Alpha 2b + Ribavirin||Phase 3|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
Experimental: Vitamin D
Vitamin D + Pegylated Interferon Alpha 2b + Ribavirin
Drug: Vitamin D + Pegylated Interferon Alpha 2b + Ribavirin
Vitamin D ARM: 28000UI/week during 4 weeks (lead in phase) then 28000 UI/week associated with PegIFN/RBV during 48 weeks
No Intervention: Standard of Care
Pegylated Interferon Alpha 2b + Ribavirin
- 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.
- Rapid Virological Response (RVR) [ Time Frame: 4 Weeks after peg-IFN/RBV initiation ]HCV RNA at 4 weeks post initiation of combination therapy (PEG IFN + RBV)
- Early Virological Response (EVR) [ Time Frame: 12 Weeks after peg-IFN/RBV initiation ]HCV RNA at 12 weeks post initiation of combination therapy
- End of Treatment Response (ETR) [ Time Frame: 48 Weeks after peg-IFN/RBV initiation ]HCV RNA at end of treatment (week 48)
- 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) ]incidence of SAE leading to dosage reduction or treatment cessation, percentage of patients treated by EPO and G-CSF
- 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02099604
|Study Chair:||Gamal Esmat, MD, PhD||NHTMRI, Cairo, Egypt|
|Study Chair:||Arnaud Fontanet, MD, PhD||Institut Pasteur, Paris France|