Chronic Hepatitis cNCT05138523
Evaluation of the Efficacy and Safety of the Fixed-dose Combination Sofosdac® 400mg/60mg in Patients With Chronic Hepatitis C (HCV)
An observational study of Chronic Hepatitis c, run by Beker Laboratories at 4 sites in Algeria.
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) Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Hepatitis c
- What is being tested?
- Sofosdac®
- How many people
- 99 participants
- Where
- 4 sitesAlgeria
- Study dates
- 21 Nov 2019to 22 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Algeria4 sites
Mustapha Pacha Teaching Hospital
Algiers, 16000
Boufarik Public Hospital
Boufarik, Blida Province, 9001
Khenchla Public Hospital
Khenchla, Khenchla, 40000
Oran Teaching Hospital
Oran, 31000
About this study
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)
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)
Read the 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).
- Conditions
- Chronic Hepatitis c
- Being tested
- Sofosdac®
- Keywords
- HCV, Cirrhotic, non-cirrhotic, sofosdac, sofosbuvir, daclatasvir, fixed-dose combination, FDC, hepatitis C, pangenotypic, genotype
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosdac®Combination product
Once daily fixed-dose combination of 400 mg Sofosbuvir and 60 mg Daclatasvir
| Study group | Role | What they receive |
|---|---|---|
| Non-cirrhotic | Non-cirrhotic HCV patients; 12 weeks treatment Receives: Combination Product: Sofosdac® | |
| Cirrhotic | Cirrhotic HCV patients; 24 weeks treatment Receives: Combination Product: Sofosdac® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks after treatment cessation
Secondary outcomes (1)
Assessment of reported adverse events
Assessment of observed adverse events / adverse effects and serious adverse events related or not related to Sofosdac® treatment.
Measured: During treatment duration defined as: 24 weeks for cirrhotics, and 12 weeks for non-cirrhotic patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start21 Nov 2019
- Primary completion18 Nov 2020
- Study completion22 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis cStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beker Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharmaceutical Research Unit, Jordan
- Responsible party
- Sponsor
- Investigators
- Nabil Debzi, MD; Professor, Principal investigator, CHU Mustapha Hepatology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138523
- Sponsor's protocol ID
- DASO2018/PRO-00
- Status last verified
- Nov 2021
- First submitted
- 4 Nov 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD collected will be available to other researchers upon their request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05138523
- Acronym / sponsor ID
- DASO2018/PRO-00
- Conditions
- Chronic Hepatitis c
- Keywords
- HCV, Cirrhotic, non-cirrhotic, sofosdac, sofosbuvir, daclatasvir, fixed-dose combination, FDC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Beker LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- Pharmaceutical Research Unit, Jordan
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 18 Nov 2020 (actual)
- Study completion
- 22 Jun 2021 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-cirrhotic | – | Combination Product: Sofosdac®Non-cirrhotic HCV patients; 12 weeks treatment |
| Cirrhotic | – | Combination Product: Sofosdac®Cirrhotic HCV patients; 24 weeks treatment |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- Patient under amiodarone
- Hepatocellular carcinoma HCC
- Haemodialysis
- Creatinine Clearance < 30ml/min
- Breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sofosdac®Once daily fixed-dose combination of 400 mg Sofosbuvir and 60 mg Daclatasvir | Combination product | Cirrhotic, Non-cirrhotic |
Primary outcome
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.
1 secondary outcome
Assessment of reported adverse events
Time frame: During treatment duration defined as: 24 weeks for cirrhotics, and 12 weeks for non-cirrhotic patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Individual participant dataSharing planned: Undecided. IPD collected will be available to other researchers upon their request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nabil Debzi, MD; Professor principal investigator
CHU Mustapha Hepatology department
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis c, run by Beker Laboratories at 4 sites in Algeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Algeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of RNA HCV 12 weeks after treatment cessation by acceptable quantification assay (time frame: 12 weeks after treatment cessation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.