OBV/PTV/r) ± ribavirin (RBV)
DrugOther names: Paritaprevir (ABT-450) is inhibitor of the NS3-4A serine protease Ombitasvir (ABT 267) is an NS5A inhibitor
NCT Number: NCT04378608
The objective of the investigators was to delineate the efficacy and safety of Ombitasvir, paritaprevir with ritonavir (OBV/PTV/r) plus ribavirin (RBV) on chronic HCV GT4 Egyptian naïve patients
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Notify Me18 year–70 year
All sexes
Interventional
Phase 1 / Phase 2
Direct-acting antivirals (DAAs) combination therapies from various mechanisms of action and families have been revolutionized the management landscape of chronic hepatitis C virus (HCV). Ombitasvir, paritaprevir with ritonavir (OBV/PTV/r) ± ribavirin (RBV) are approved to treat HCV genotype 4 (GT4) infection. Here, investigators' objective was to delineate the efficacy and safety of OBV/PTV/r plus RBV of HCV GT4 in the treatment of Egyptian naïve patients.
Between 5 January and 8 September 2017, a cohort of 100 Egyptian patients infected with HCV GT4 was allocated and administered orally OBV/PTV/r with RBV, for 12 weeks, which given as oral tablets based on patient tolerability. The primary endpoint of investigators' study was a sustained virological response (HCV RNA < 12 IU/mL) 12 weeks from the cessation of the treatment (SVR12).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Treatment-naïve patients with HCV GT4 with plasma HCV RNA level >10,000 IU/ml
Exclusion criteria
Other names: Paritaprevir (ABT-450) is inhibitor of the NS3-4A serine protease Ombitasvir (ABT 267) is an NS5A inhibitor
Time frame: 12 weeks after last dose
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 12 IU/mL 12 weeks after the last dose of study drug.
Time frame: Screening up to 30 days after last dose
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation observed after administering a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is an event that results in, death, participant hospitalization, life-threatening, significant disability/incapacity, or a congenital anomaly.
Time frame: Up to 12 weeks after last dose
Post-treatment relapse was defined as defined as confirmed HCV RNA > 12 IU/ml between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < 12 IU/ml at the end of treatment.
Beni-Suef University
Other
Efficacy of Ombitasvir With Paritaprevir/Ritonavir Plus Ribavirin on the Treatment naïve Patients With Chronic Hepatitis C Virus Genotype 4
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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