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

November 16, 2021 updated by: Beker Laboratories

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)

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

99

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Algeria
      • Algiers, Algeria, 16000
        • Mustapha Pacha Teaching Hospital
      • Khenchla, Algeria, 40000
        • Khenchla Public Hospital
      • Oran, Algeria, 31000
        • Oran Teaching Hospital
    • Blida
      • Boufarik, Blida, Algeria, 9001
        • Boufarik Public Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of RNA HCV 12 weeks after treatment cessation by acceptable quantification assay
Time Frame: 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.
12 weeks after treatment cessation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of reported adverse events
Time Frame: 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.
During treatment duration defined as: 24 weeks for cirrhotics, and 12 weeks for non-cirrhotic patients

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beker Laboratories

Collaborators

Pharmaceutical Research Unit, Jordan

Investigators

  • Principal Investigator: Nabil Debzi, MD; Professor, CHU Mustapha Hepatology department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 21, 2019

Primary Completion (ACTUAL)

November 18, 2020

Study Completion (ACTUAL)

June 22, 2021

Study Registration Dates

First Submitted

November 4, 2021

First Submitted That Met QC Criteria

November 16, 2021

First Posted (ACTUAL)

December 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 1, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DASO2018/PRO-00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD collected will be available to other researchers upon their request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Hepatitis c

Clinical Trials on Sofosdac®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe