NCT04391985

Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir and Ribavirin for Hepatitis C Virus Genotype 4 Patients

Retreatment Efficacy of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir + Ribavirin for Hepatitis C Virus Genotype 4 Patients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Beni-Suef University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

enrolled participants were treated orally with SOF plus a fixed dose combination of OBV/PTV/r plus RBV.

Detailed description

Enrolled participants were treated orally with SOF plus a fixed dose combination of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir plus Ribavirin (OBV/PTV/r plus RBV), which was administered orally based on the participants' tolerability. The primary end point was a sustained virological response (HCV RNA level \< 15 IU/ mL), observed 12 weeks after the end of the treatment (SVR12).

Conditions

• Chronic Hepatitis C Virus Infection

Interventions

Type	Name	Description
DRUG	SOF plus (OBV/PTV/r) plus RBV	They were given SOF in a dose of 400 mg/day, and a fixed dose combination of OBV (25 mg), PTV (150 mg), and r (100 mg) taken with food once daily. RBV was supplied in 200 mg capsules, and the recommended dose was 600 mg/ day to reach 1200 mg/day based on patient's body weight and tolerability.

Timeline

• Start date: 2017-03-01
• Primary completion: 2017-10-31
• Completion: 2017-10-31
• First posted: 2020-05-18
• Last updated: 2020-05-18

Locations

1 site across 1 country: Egypt