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

Sponsor

Beker Laboratories (Industry)

Overall Status

Completed

CT.gov ID

NCT05138523

Collaborator

Pharmaceutical Research Unit, Jordan (Other)

Enrollment

Locations

Actual Duration (Months)

24.8

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis c	Combination Product: Sofosdac®

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 Design

Study Type:

Observational

Actual Enrollment :

99 participants

Observational Model:

Other

Time Perspective:

Prospective

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)

Actual Study Start Date :

Nov 21, 2019

Actual Primary Completion Date :

Nov 18, 2020

Actual Study Completion Date :

Jun 22, 2021

Arms and Interventions

Arm	Intervention/Treatment
Non-cirrhotic Non-cirrhotic HCV patients; 12 weeks treatment	Combination Product: Sofosdac® Once daily fixed-dose combination of 400 mg Sofosbuvir and 60 mg Daclatasvir
Cirrhotic Cirrhotic HCV patients; 24 weeks treatment	Combination Product: Sofosdac® Once daily fixed-dose combination of 400 mg Sofosbuvir and 60 mg Daclatasvir

Arm

Intervention/Treatment

Non-cirrhotic

Non-cirrhotic HCV patients; 12 weeks treatment

Combination Product: Sofosdac®

Once daily fixed-dose combination of 400 mg Sofosbuvir and 60 mg Daclatasvir

Cirrhotic

Cirrhotic HCV patients; 24 weeks treatment

Combination Product: Sofosdac®

Once daily fixed-dose combination of 400 mg Sofosbuvir and 60 mg Daclatasvir

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boufarik Public Hospital	Boufarik	Blida	Algeria	9001
2	Mustapha Pacha Teaching Hospital	Algiers		Algeria	16000
3	Khenchla Public Hospital	Khenchla		Algeria	40000
4	Oran Teaching Hospital	Oran		Algeria	31000