Trials / Completed
CompletedNCT05138523
Evaluation of the Efficacy and Safety of the Fixed-dose Combination Sofosdac® 400mg/60mg in Patients With Chronic Hepatitis C (HCV)
Observational, Open Label Study With Direct Individual Benefit Assessing the Efficacy and Safety of Sofosdac® 400mg/60mg Tablets (400 mg Sofosbuvir and 60 mg of Daclatasvir) Treatment in Patients With Chronic Hepatitis C (HCV)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 99 (actual)
- Sponsor
- Beker Laboratories · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
A multicentric, observational, open-design study conducted to evaluate the efficacy and safety of Sofosdac® 400mg/60mg tablets treatment in 100 patients with chronic hepatitis C (HCV)
Detailed description
BEKER laboratories developed the generic drug Sofosdac® 400 mg/60 mg Tablets as fixed dose combination that contains two direct antiviral agents (400 mg Sofosbuvir and 60 mg Daclatasvir) known to be pangenotypic in order to fulfill WHO plan to eradicate HCV by 2030. BEKER conducted an observational clinical trial to evaluate the efficacy and safety of FDC Sofosdac® 400 mg/60 mg treatment in Algerian patients with chronic hepatitis C (HCV).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Sofosdac® | Once daily fixed-dose combination of 400 mg Sofosbuvir and 60 mg Daclatasvir |
Timeline
- Start date
- 2019-11-21
- Primary completion
- 2020-11-18
- Completion
- 2021-06-22
- First posted
- 2021-12-01
- Last updated
- 2021-12-01
Locations
4 sites across 1 country: Algeria
Source: ClinicalTrials.gov record NCT05138523. Inclusion in this directory is not an endorsement.