Vitamin D as an add-on Therapy With Pegylated Interferon and Ribavirin for Chronic Hepatitis c
|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.
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|