NCT04246723

Efficacy and Safety of All-Oral Combination of Narlaprevir/Ritonavir and Sofosbuvir in Treatment-naïve Patients With Chronic Hepatitis C Genotype 1

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: R-Pharm · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, open-label, phase II safety and efficacy study of all-oral combination of narlaprevir/ritonavir and sofosbuvir in Treatment-naïve Patients with Chronic Hepatitis C Genotype 1.

Detailed description

Two patient cohorts were anticipated in this study: 1. Cohort A: 60 treatment-naive patients were enrolled into narlaprevir/ritonavir/sofosbuvir treatment for 12 weeks. 2. Cohort B: (exploratory): 25 treatment-naive patients with low viral load (HCV RNA\<1000000 IU/L) were enrolled into narlaprevir/ritonavir/sofosbuvir treatment for 8 weeks. The enrollment of 25 treatment-naïve patients with low viral load into 8 week cohort started after completion of enrollment of 60 treatment-naive patients into 12 week cohort. The study included 3 time periods: 1. Screening period with duration up to 2 weeks during which study eligibility was confirmed. 2. Active treatment period (for 12 or 8 weeks): patients in the Cohort A were receiving study therapy with narlaprevir/ritonavir/sofosbuvir for 12 weeks, in the Cohort B - during 8 weeks. If a patient had virologic breakthrough while receiving therapy, discontinuation of antiviral treatment was advised with appropriate clinical follow-up. 3. Follow-up period during which patients did not receive any study medication. The duration of the follow-up period after the end of study treatment was 24 weeks. Overall, each patient had been participating in the study for approximately up to 38 weeks from the time the patient signed the Informed Consent Form through the final visit. If a patient had a screening failure, but was rescreened and subsequently enrolled, the reason for the original screening failure must have been documented in the source documents. A new subject Identification number (ID) was assigned to the patient. The recruitment period in this study was planned to be up to 6 months. The total period of the study was anticipated to be approximately 1 year 3 months. The patient was considered to be completed the study upon the completion of the last protocol specified visit. For those patients who did not complete the study, patient participation was considered terminated upon the completion of the last visit or contact (e.g., phone contact with the investigator). It was estimated that 85 patients meeting inclusion/exclusion criteria would be recruited from approximately 6 clinical sites in Russia.

Conditions

• Chronic Hepatitis c Genotype 1

Interventions

Type	Name	Description
DRUG	Narlaprevir	100 mg oval shaped, concave, yellow film-coated tablets taken as 200 mg per os once daily. 28 tabs/36 tabs/ 56 tabs in bottle.
DRUG	Ritonavir	100 mg tablets taken as 100 mg per os once daily. 30 tablets in bottle
DRUG	Sofosbuvir	400 mg yellow, capsule-shaped film-coated tablets debossed with "GSI" on one side and "7977" on the other side, taken as 400 mg per os once daily. 28 tablets in bottle.

Timeline

• Start date: 2019-05-06
• Primary completion: 2020-04-08
• Completion: 2020-08-12
• First posted: 2020-01-29
• Last updated: 2022-10-31

Locations

5 sites across 1 country: Russia