Multicenter, open-label, phase II safety and efficacy study of all-oral combination of
narlaprevir/ritonavir and sofosbuvir in Treatment-nave Patients with Chronic Hepatitis C
Two patient cohorts are anticipated in this study:
Cohort A: 60 treatment-naive patients will be enrolled into
narlaprevir/ritonavir/sofosbuvir treatment for 12 weeks.
Cohort B: (exploratory): 25 treatment-naive patients with low viral load (HCV
RNA<1000000 IU/L) will be enrolled into narlaprevir/ritonavir/sofosbuvir treatment for 8
The enrollment of 25 treatment-nave patients with low viral load into 8 week cohort will
start after completion of enrollment of 60 treatment-naive patients into 12 week cohort.
The study will include 3 time periods:
Screening period with duration up to 2 weeks during which study eligibility will be
Active treatment period (for 12 or 8 weeks): patients in the Cohort A will receive study
therapy with narlaprevir/ritonavir/sofosbuvir for 12 weeks, in the Cohort B - during 8
If a patient has virologic breakthrough while receiving therapy, discontinuation of
antiviral treatment is advised with appropriate clinical follow-up.
3. Follow-up period during which patients do not receive any study medication. The duration
of the follow-up period after the end of study treatment will be 24 weeks.
Overall, each patient will participate in the study for approximately up to 38 weeks from the
time the patient signs the Informed Consent Form through the final visit.
If a patient is a screening failure, but is rescreened and subsequently enrolled, the reason
for the original screening failure must be documented in the source documents. A new subject
Identification number (ID) will be assigned to the patient.
The recruitment period in this study is planned to be up to 6 months. The total period of the
study is anticipated to be approximately 1 year 3 months.
The patient is considered to be completed the study upon the completion of the last protocol
specified visit. For those patients who do not complete the study, patient participation will
be considered terminated upon the completion of the last visit or contact (e.g., phone
contact with the investigator).
It is estimated that 85 patients meeting inclusion/exclusion criteria will be recruited from
approximately 6 clinical sites in Russia
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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