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

Chronic Hepatitis c Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05138523
• Other study ID #: DASO2018/PRO-00
• Status: Completed
• Start date: November 21, 2019
• Est. completion date: June 22, 2021

Study information

• Verified date: November 2021
• Source: Beker Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: June 22, 2021
• Est. primary completion date: November 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis c
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Combination Product:
• Sofosdac®
Once daily fixed-dose combination of 400 mg Sofosbuvir and 60 mg Daclatasvir

Locations

Country	Name	City	State
Algeria	Mustapha Pacha Teaching Hospital	Algiers
Algeria	Boufarik Public Hospital	Boufarik	Blida
Algeria	Khenchla Public Hospital	Khenchla
Algeria	Oran Teaching Hospital	Oran

Sponsors (2)

Lead Sponsor	Collaborator
Beker Laboratories	Pharmaceutical Research Unit, Jordan

Country where clinical trial is conducted

Algeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of RNA HCV 12 weeks after treatment cessation by acceptable quantification assay	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.	12 weeks after treatment cessation
Secondary	Assessment of reported adverse events	Assessment of observed adverse events / adverse effects and serious adverse events related or not related to Sofosdac® treatment.	During treatment duration defined as: 24 weeks for cirrhotics, and 12 weeks for non-cirrhotic patients