Trials / Completed
CompletedNCT04387526
Sofosbuvir Plus Daclatasvir With or Without Ribavirin and Chronic HCV Genotype (GT) 4
Efficacy and Safety of Sofosbuvir Plus Daclatasvir With or Without Ribavirin: Large Real-life Results of Patients With Chronic Hepatitis C Genotype 4
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 946 (actual)
- Sponsor
- Beni-Suef University · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to evaluate the efficacy and safety of DCV plus sofosbuvir (SOF) with or without ribavirin (RBV) for treatment of Egyptian participants infected with HCV GT4.
Detailed description
Egyptian participants infected with HCV GT4 were classified into two groups: group 1 (easy to treat) was treated with a dual therapy of SOF/DCV daily for 12 weeks and group 2 (difficult to treat) was treated with a triple therapy of SOF/DCV/RBV daily for 12 weeks. SOF dose was 400 mg/day given orally DCV was given in a dose of 60 mg/day, orally. RBV was given as oral tablets in the morning and in the evening based on patient's weight and tolerability (starting dose 600 mg/day to reach 1200 mg/day.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | (SOF and DCV) | |
| DRUG | (SOF, DCV, and RBV) |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2017-05-31
- Completion
- 2017-05-31
- First posted
- 2020-05-14
- Last updated
- 2020-05-15
Source: ClinicalTrials.gov record NCT04387526. Inclusion in this directory is not an endorsement.