Vitamin D as an add-on Therapy With Pegylated Interferon and Ribavirin for Chronic Hepatitis c
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|ClinicalTrials.gov Identifier: NCT01655966|
Recruitment Status : Unknown
Verified January 2014 by Hany Shehab, Cairo University.
Recruitment status was: Active, not recruiting
First Posted : August 2, 2012
Last Update Posted : January 29, 2014
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis c||Drug: vitamin D +pegylated interferon + ribavirin Drug: pegylated interferon + ribavirin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vitamin D in Addition to Pegylated Interferon and Ribavirin Compared to Pegylated Interferon and Ribavirin Alone in the Treatment of Chronic Hepatitis C Genotype 4.|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||February 2014|
|Estimated Study Completion Date :||April 2014|
Active Comparator: Standard of care
Group A: comprises 40 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
Drug: pegylated interferon + ribavirin
pegylated interferon 160ug once weekly Ribavirin (> 75kg:1200 mg, <75kg:1000mg daily)48 weeks
Experimental: Triple therapy
Group B: comprises 40 treatment-naive chronic HCV patients who will receive oral vitamin D 1mcg once daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
Drug: vitamin D +pegylated interferon + ribavirin
Vitamin D: 1mcg once daily 48 weeks Pegylated interferon 160ug once weekly 48 weeks Ribavirin(> 75kg:1200 mg, <75kg:1000mg daily)48 weeks
- Sustained virologic response [ Time Frame: 72 weeks ]Undetectable HCV-RNA 24 weeks after end of treatment.
- rapid virologic response [ Time Frame: 4 weeks ]undetectable HCV-RNA 4 weeks after commencement of treatment
- End-of-treatment response [ Time Frame: 48 weeks ]undetectable HCV-RNA 48 weeks after commencement of treatment
- Adverse events [ Time Frame: 72 weeks ]Adverse events that could be reasonably and temporally associated with administration of drugs
- early virologic response [ Time Frame: 12 weeks ]
Early virologic response: undetectable HCV-RNA 12 weeks after commencement of treatment.
Partial early virologic response: decrease of more than 2login HCV-RNA.
No early virologic response: increase, stationary or decreased less than 2log HCV-RNA.
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): NCT01655966
|National Railway Hospital Center|
|Principal Investigator:||Tamer Elbaz, MD||Cairo University|
|Study Director:||Hany Shehab, MD||Cairo University|