Clinical trial NCT05138523: Evaluation of the Efficacy and Safety of the Fixed-dose Combination Sofosdac® 400mg/60mg in Patients With Chronic Hepatitis C (HCV)
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis c
Keywords: HCV
Cirrhotic
non-cirrhotic
sofosdac
sofosbuvir
daclatasvir
fixed-dose combination
FDC
hepatitis C
pangenotypic
genotype
Lead sponsor: Beker Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Pharmaceutical Research Unit, Jordan
First posted: 2021-12-01
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects in the study were enrolled from five centers (primary care facilities) across different regions in the country; East, Center and West of Algeria.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Detection of RNA HCV 12 weeks after treatment cessation by acceptable quantification assay
timeFrame: 12 weeks after treatment cessation
Secondary outcomes:
measure: Assessment of reported adverse events
timeFrame: During treatment duration defined as: 24 weeks for cirrhotics, and 12 weeks for non-cirrhotic patients
Other outcomes:
Locations:
city: Boufarik
country: Algeria
facility: Boufarik Public Hospital
state: Blida
city: Algiers
country: Algeria
facility: Mustapha Pacha Teaching Hospital
city: Khenchla
country: Algeria
facility: Khenchla Public Hospital
city: Oran
country: Algeria
facility: Oran Teaching Hospital
Study officials:
affiliation: CHU Mustapha Hepatology department
name: Nabil Debzi, MD; Professor
role: PRINCIPAL_INVESTIGATOR
References: