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

NCT05138523 | Completed

• 1 other identifier: DASO2018/PRO-00
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 4

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)

Conditions

Chronic Hepatitis c

Keywords

HCV; Cirrhotic; non-cirrhotic; sofosdac; sofosbuvir; daclatasvir; fixed-dose combination; FDC; hepatitis C; pangenotypic; genotype

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment of reported adverse events

  During treatment duration defined as: 24 weeks for cirrhotics, and 12 weeks for non-cirrhotic patients

Study Arms (2)

Non-cirrhotic

Non-cirrhotic HCV patients; 12 weeks treatment

Combination Product: Sofosdac®

Cirrhotic

Cirrhotic HCV patients; 24 weeks treatment

Combination Product: Sofosdac®

Interventions

Sofosdac® COMBINATION_PRODUCT

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

Cirrhotic; Non-cirrhotic

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Beker Laboratories: lead
• Pharmaceutical Research Unit, Jordan: collaborator

Study Sites (4)

Boufarik Public Hospital

Boufarik, Blida Province, 9001, Algeria

Location

Khenchla Public Hospital

Khenchla, Khenchla, 40000, Algeria

Location

Mustapha Pacha Teaching Hospital

Algiers, 16000, Algeria

Location

Oran Teaching Hospital

Oran, 31000, Algeria

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nabil Debzi, MD; Professor

  CHU Mustapha Hepatology department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: December 1, 2021
• Study Start: November 21, 2019
• Primary Completion: November 18, 2020
• Study Completion: June 22, 2021
• Last Updated: December 1, 2021

Record last verified: 2021-11

Locations

AL (4)