Evaluation of the Efficacy and Safety of the Fixed-dose Combination Sofosdac® 400mg/60mg in Patients With Chronic Hepatitis C (HCV)

Completed

• Conditions: Chronic Hepatitis c
• Interventions: Combination Product: Sofosdac®

• Registration Number: NCT05138523
• Lead Sponsor: Beker Laboratories

Brief 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).

Study Timeline

• Study Start: 2019-11-21
• Primary Completion: 2020-11-18
• Study Completion: 2021-06-22
• Status Verified: 2021-11
• Study First Submitted: 2021-11-04
• Study First Submitted QC: 2021-11-16
• Last Update Submitted: 2021-11-16
• Study First Posted: 2021-12-01
• Last Update Posted: 2021-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• Men and women age of 18 years old and older.
• HCV chronic Infection, genotype 1 or 2 or 3 or 4 or 5 or 6
• Naive
• Bi-therapy failure, Tri-therapy 1st generation Telaprévir and Boceprevir, Sofosbuvir - pegIFN - RBV failure
• Evaluation of fibrosis by non-invasive methods (Fibroscan, Fib 4, APRI) performed during the pre-inclusion period (of at least one month) or A Liver biopsy puncture of at least 24 months before the inclusion visit.
• Fibrosis according to Metavir score: F0, F1, F2, F3, F4.
• Compensated Cirrhosis Child-Pugh A or
• Decompensated Cirrhosis (This point is applicable for patients who have cirrhosis)

Exclusion Criteria

• Patient under amiodarone
• Hepatocellular carcinoma HCC
• Haemodialysis
• Creatinine Clearance < 30ml/min
• Breastfeeding
• Impossibility of using effective masculine or feminine contraception during the study and 6 months after treatment cessation.
• Medications triggering conduction disturbances with long QT, 30 days prior to inclusion
• QT prolongation > 450 ms
• Personal or familial history of torsade de pointes
• Allergies to nucleosi(ti)des analogues.
• Advanced cardiopulmonary pathology
• Malignant neoplasia
• The intake of anticonvulsants: Carbamazepine, eslicarbazepine, fosphenytoin, phenytoin, oxcarbazepine, pentobarbital, phenobarbital, primidone or the antimycobacterial agents: Rifabutin, rifampin

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cirrhotic	Sofosdac®	Cirrhotic HCV patients; 24 weeks treatment
Non-cirrhotic	Sofosdac®	Non-cirrhotic HCV patients; 12 weeks treatment

Primary Outcome Measures

Name	Time	Method
Detection of RNA HCV 12 weeks after treatment cessation by acceptable quantification assay	12 weeks after treatment cessation	A quantification assay is performed to all patients to detect RNA HCV in order to determine the proportion of patients who achieve SVR12 (Sustained Viral Response) defined as: RNA HCV \< LLOQ (Lower Limit of Quantification) 12 weeks after treatment cessation.

Secondary Outcome Measures

Name	Time	Method
Assessment of reported adverse events	During treatment duration defined as: 24 weeks for cirrhotics, and 12 weeks for non-cirrhotic patients	Assessment of observed adverse events / adverse effects and serious adverse events related or not related to Sofosdac® treatment.

Trial Locations

Locations (4)

Boufarik Public Hospital; 🇩🇿 Boufarik, Blida, Algeria

Oran Teaching Hospital; 🇩🇿 Oran, Algeria

Mustapha Pacha Teaching Hospital; 🇩🇿 Algiers, Algeria

Khenchla Public Hospital; 🇩🇿 Khenchla, Algeria