Hepatitis CNCT02772744
Determining the Sustained Virologic Response of Declatasvir in Egyptian Patients With Hepatitis C Virus Genotype 4
An observational study of Hepatitis C, run by Zagazig University.
Trial summary
This is a prospective, cohort study in Faculty of Medicine, Zagazig University, Egypt. From June to December, 2016, investigators will follow up patients with chronic Hepatitis C virus genotype 4 receiving daclatasvir-sofosbuvir treatment regimen within the national program of Egyptian ministry of health and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Daclatasvir 60 MG Oral Tablet [Daklinza], Sofosbuvir 400 MG Oral Tablet [Sovaldi] and Ribavirin Oral Product
- Type of treatment
- Pill or oral medicine
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2017to 31 Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include male or female patients ≥ 18 years, HCV RNA≥ 104 IU/mL, HCV genotype 4, screening ECG without clinically significant abnormalities.
Who may be able to join
- Patients with HCV genotype 4
- Age ≥ 18 years
- HCV RNA≥ 104 IU/mL
- Screening ECG without clinically significant abnormalities.
Who cannot join
- Total serum bilirubin > 3 mg/dl.
- Serum albumin < 2.8 g/dl.
- INR ≥ 1.7
- Platelet count < 50000/mm3.
- Hepatic cell carcinoma except four weeks after intervention aiming to cure with no evidence of activity by dynamic imaging (CT or MRI).
- Extra hepatic malignancy except after two years of disease free interval
- Pregnancy or inability to use contraception.
- Inadequately controlled diabetes mellitus (HbA1c > 9%).
Trial locations and contacts
No sites are listed yet.
About this study
This is a prospective, cohort study in Faculty of Medicine, Zagazig University, Egypt. From June to December, 2016, investigators will follow up patients with chronic Hepatitis C virus genotype 4 receiving daclatasvir-sofosbuvir treatment regimen within the national program of Egyptian ministry of health and population. The primary outcomes are safety of the treatment and the sustained virologic response 12 weeks after discontinuation of therapy. For the secondary outcomes, investigators will measure the change in health related quality of life and investigate the genetic sequence of viral RNA of resistant patients.
- Conditions
- Hepatitis C
- Being tested
- Daclatasvir 60 MG Oral Tablet [Daklinza], Sofosbuvir 400 MG Oral Tablet [Sovaldi], Ribavirin Oral Product
- Keywords
- Hepatitis C virus genotype 4, Antiviral, Virologic Response
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daclatasvir 60 MG Oral Tablet [Daklinza]Drug
Daclatasvir (60 MG) is a potent, pan-genotypic inhibitor of the HCV NS5A protein
Sofosbuvir 400 MG Oral Tablet [Sovaldi]Drug
Sofosbuvir (400 MG) is a nucleotide analogue HCV NS5B polymerase inhibitor
Ribavirin Oral ProductDrug
Ribavirin (twice-daily) dosed according to body weight (<75 kg, 1000 mg daily; ≥75 kg, 1200 mg daily)
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Easy to treat group | * Treatment naïve
* Total serum bilirubin ≤ 1.2 mg/dl
* Serum albumin ≥ 3.5 g/dl
* International normalized ratio ≤ 1.2
* Platelet count ≥ 150000 mm3
This group will be receiving Sofosbuvir + daclatasvir for 12 weeks. Receives: Drug: Daclatasvir 60 MG Oral Tablet [Daklinza]; Drug: Sofosbuvir 400 MG Oral Tablet [Sovaldi] | |
| Group 2: Difficult to treat group | * Peg interferon treatment experienced.
* Total serum bilirubin ≥ 1.2 mg/dl
* Serum albumin ≤ 3.5 g/dl
* International normalized ratio ≥ 1.2
* Platelet count ≤ 150000 mm3
This group will be receiving Sofosbuvir + daclatasvir + ribavirin for 12 weeks. Receives: Drug: Daclatasvir 60 MG Oral Tablet [Daklinza]; Drug: Sofosbuvir 400 MG Oral Tablet [Sovaldi]; Drug: Ribavirin Oral Product | |
| Group 3: Sofosbuvir resistant cases | This is the group of patients who failed in previous Sofosbuvir treatment regiment. This group will be receiving Sofosbuvir + daclatasvir + ribavirin for 24 weeks. Receives: Drug: Daclatasvir 60 MG Oral Tablet [Daklinza]; Drug: Sofosbuvir 400 MG Oral Tablet [Sovaldi]; Drug: Ribavirin Oral Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy measured by Sustained Virologic Response Rate
Measured: 12 weeks posttreatment
Incidence of grade 3/4 adverse events [Safety]
Measured: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Incidence of Neutropenia [Safety]
Neutropenia: Grade 3, 500-749/mm3; Grade 4, <500/mm3
Measured: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Incidence of Lymphopenia [Safety]
Lymphopenia: Grade 3, 350-499/mm3; Grade 4, <350/mm3
Measured: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Incidence of anaemia [Safety]
Anaemia: Grade 3, haemoglobin 7.0-8.9 g/dL; Grade 4, <7.0 g/dL
Measured: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Incidence of Thrombocytopenia [Safety]
Thrombocytopenia: Grade 3, 25 000-49 999/mm3; Grade 4, <25 000/mm3
Measured: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Incidence of (Increased total Bilirubin) [Safety]
Bilirubin elevations: Grade 3, 2.6-5×ULN; Grade 4, >5×ULN
Measured: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Incidence of elevated Alanine Aminotransferase [Safety]
Alanine Aminotransferase elevations: Grade 3, 5.1-10×upper limit of normal (ULN); Grade 4, >10×ULN
Measured: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Incidence of Fatigue [Safety]
Measured: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Incidence of Headache [Safety]
Measured: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Incidence of Pruritus [Safety]
Measured: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Incidence of Insomnia [Safety]
Measured: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Incidence of Rash [Safety]
Measured: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Incidence of Nausea [Safety]
Measured: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Incidence of Myalgia [Safety]
Measured: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Secondary outcomes (1)
Health Related Quality of Life (HRQoL)
HRQoL will be assessed using the Arabic version of SF-36 questionnaire (SF-36™ Health Survey)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study start1 Nov 2017 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Ahmed Negida, Zagazig University
- Investigators
- Samah A Loutfy, Study director, National Cancer Institute, Cairo University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772744
- Sponsor's protocol ID
- 2667-20-3-2016
- Status last verified
- Oct 2017
- First submitted
- 24 Mar 2016
- Last updated
- 10 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Jensen D, Sherman KE, Hezode C, Pol S, Zeuzem S, de Ledinghen V, Tran A, Elkhashab M, Younes ZH, Kugelmas M, Mauss S, Everson G, Luketic V, Vierling J, Serfaty L, Brunetto M, Heo J, Bernstein D, McPhee F, Hennicken D, Mendez P, Hughes E, Noviello S; HALLMARK-QUAD Study Team. Daclatasvir and asunaprevir plus peginterferon alfa and ribavirin in HCV genotype 1 or 4 non-responders. J Hepatol. 2015 Jul;63(1):30-7. doi: 10.1016/j.jhep.2015.02.018. Epub 2015 Feb 19.
PubMed 25703086Hezode C, Alric L, Brown A, Hassanein T, Rizzetto M, Buti M, Bourliere M, Thabut D, Molina E, Rustgi V, Samuel D, McPhee F, Liu Z, Yin PD, Hughes E, Treitel M; COMMAND-4 study team. Randomized controlled trial of the NS5A inhibitor daclatasvir plus pegylated interferon and ribavirin for HCV genotype-4 (COMMAND-4). Antivir Ther. 2015 Aug 27;21(3):195-205. doi: 10.3851/IMP2985. Online ahead of print.
PubMed 26313445Wyles DL, Ruane PJ, Sulkowski MS, Dieterich D, Luetkemeyer A, Morgan TR, Sherman KE, Dretler R, Fishbein D, Gathe JC Jr, Henn S, Hinestrosa F, Huynh C, McDonald C, Mills A, Overton ET, Ramgopal M, Rashbaum B, Ray G, Scarsella A, Yozviak J, McPhee F, Liu Z, Hughes E, Yin PD, Noviello S, Ackerman P; ALLY-2 Investigators. Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1. N Engl J Med. 2015 Aug 20;373(8):714-25. doi: 10.1056/NEJMoa1503153. Epub 2015 Jul 21.
PubMed 26196502
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Sustained Virologic Response of Declatasvir in Egyptian Patients With Hepatitis C Virus Genotype 4
- ClinicalTrials.gov ID
- NCT02772744
- Acronym / sponsor ID
- 2667-20-3-2016
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C virus genotype 4, Antiviral, Virologic Response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Collaborators
- Cairo University
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 13 May 2016 (estimated)
- 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.
This is a prospective, cohort study in Faculty of Medicine, Zagazig University, Egypt. From June to December, 2016, investigators will follow up patients with chronic Hepatitis C virus genotype 4 receiving daclatasvir-sofosbuvir treatment regimen within the national program of Egyptian ministry of health and population. The primary outcomes are safety of the treatment and the sustained virologic response 12 weeks after discontinuation of therapy. For the secondary outcomes, investigators will measure the change in health related quality of life and investigate the genetic sequence of viral RNA of resistant patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Easy to treat group | – | Drug: Daclatasvir 60 MG Oral Tablet [Daklinza], Drug: Sofosbuvir 400 MG Oral Tablet [Sovaldi]* Treatment naïve * Total serum bilirubin ≤ 1.2 mg/dl * Serum albumin ≥ 3.5 g/dl * International normalized ratio ≤ 1.2 * Platelet count ≥ 150000 mm3 This group will be receiving Sofosbuvir + daclatasvir for 12 weeks. |
| Group 2: Difficult to treat group | – | Drug: Daclatasvir 60 MG Oral Tablet [Daklinza], Drug: Sofosbuvir 400 MG Oral Tablet [Sovaldi], Drug: Ribavirin Oral Product* Peg interferon treatment experienced. * Total serum bilirubin ≥ 1.2 mg/dl * Serum albumin ≤ 3.5 g/dl * International normalized ratio ≥ 1.2 * Platelet count ≤ 150000 mm3 This group will be receiving Sofosbuvir + daclatasvir + ribavirin for 12 weeks. |
| Group 3: Sofosbuvir resistant cases | – | Drug: Daclatasvir 60 MG Oral Tablet [Daklinza], Drug: Sofosbuvir 400 MG Oral Tablet [Sovaldi], Drug: Ribavirin Oral ProductThis is the group of patients who failed in previous Sofosbuvir treatment regiment. This group will be receiving Sofosbuvir + daclatasvir + ribavirin for 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include male or female patients ≥ 18 years, HCV RNA≥ 104 IU/mL, HCV genotype 4, screening ECG without clinically significant abnormalities.
Key inclusion criteria (4 listed)
- Patients with HCV genotype 4
- Age ≥ 18 years
- HCV RNA≥ 104 IU/mL
- Screening ECG without clinically significant abnormalities.
Key exclusion criteria (8 listed)
- Total serum bilirubin > 3 mg/dl.
- Serum albumin < 2.8 g/dl.
- INR ≥ 1.7
- Platelet count < 50000/mm3.
- Hepatic cell carcinoma except four weeks after intervention aiming to cure with no evidence of activity by dynamic imaging (CT or MRI).
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 |
|---|---|---|
| Daclatasvir 60 MG Oral Tablet [Daklinza]Daclatasvir (60 MG) is a potent, pan-genotypic inhibitor of the HCV NS5A protein | Drug | Group 1: Easy to treat group, Group 2: Difficult to treat group, Group 3: Sofosbuvir resistant cases |
| Sofosbuvir 400 MG Oral Tablet [Sovaldi]Sofosbuvir (400 MG) is a nucleotide analogue HCV NS5B polymerase inhibitor | Drug | Group 1: Easy to treat group, Group 2: Difficult to treat group, Group 3: Sofosbuvir resistant cases |
| Ribavirin Oral ProductRibavirin (twice-daily) dosed according to body weight (<75 kg, 1000 mg daily; ≥75 kg, 1200 mg daily) | Drug | Group 2: Difficult to treat group, Group 3: Sofosbuvir resistant cases |
Primary outcome
Efficacy measured by Sustained Virologic Response Rate
Time frame: 12 weeks posttreatment
Incidence of grade 3/4 adverse events [Safety]
Time frame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Incidence of Neutropenia [Safety]
Time frame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Neutropenia: Grade 3, 500-749/mm3; Grade 4, <500/mm3
Incidence of Lymphopenia [Safety]
Time frame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Lymphopenia: Grade 3, 350-499/mm3; Grade 4, <350/mm3
Incidence of anaemia [Safety]
Time frame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Anaemia: Grade 3, haemoglobin 7.0-8.9 g/dL; Grade 4, <7.0 g/dL
Incidence of Thrombocytopenia [Safety]
Time frame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Thrombocytopenia: Grade 3, 25 000-49 999/mm3; Grade 4, <25 000/mm3
Incidence of (Increased total Bilirubin) [Safety]
Time frame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Bilirubin elevations: Grade 3, 2.6-5×ULN; Grade 4, >5×ULN
Incidence of elevated Alanine Aminotransferase [Safety]
Time frame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Alanine Aminotransferase elevations: Grade 3, 5.1-10×upper limit of normal (ULN); Grade 4, >10×ULN
Incidence of Fatigue [Safety]
Time frame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Incidence of Headache [Safety]
Time frame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Incidence of Pruritus [Safety]
Time frame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Incidence of Insomnia [Safety]
Time frame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Incidence of Rash [Safety]
Time frame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Incidence of Nausea [Safety]
Time frame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Incidence of Myalgia [Safety]
Time frame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
1 secondary outcome
Health Related Quality of Life (HRQoL)
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2017.
- Background: PubMed 25703086Jensen D, Sherman KE, Hezode C, Pol S, Zeuzem S, de Ledinghen V, Tran A, Elkhashab M, Younes ZH, Kugelmas M, Mauss S, Everson G, Luketic V, Vierling J, Serfaty L, Brunetto M, Heo J, Bernstein D, McPhee F, Hennicken D, Mendez P, Hughes E, Noviello S; HALLMARK-QUAD Study Team. Daclatasvir and asunaprevir plus peginterferon alfa and ribavirin in HCV genotype 1 or 4 non-responders. J Hepatol. 2015 Jul;63(1):30-7. doi: 10.1016/j.jhep.2015.02.018. Epub 2015 Feb 19.
- Background: PubMed 26313445Hezode C, Alric L, Brown A, Hassanein T, Rizzetto M, Buti M, Bourliere M, Thabut D, Molina E, Rustgi V, Samuel D, McPhee F, Liu Z, Yin PD, Hughes E, Treitel M; COMMAND-4 study team. Randomized controlled trial of the NS5A inhibitor daclatasvir plus pegylated interferon and ribavirin for HCV genotype-4 (COMMAND-4). Antivir Ther. 2015 Aug 27;21(3):195-205. doi: 10.3851/IMP2985. Online ahead of print.
- Background: PubMed 26196502Wyles DL, Ruane PJ, Sulkowski MS, Dieterich D, Luetkemeyer A, Morgan TR, Sherman KE, Dretler R, Fishbein D, Gathe JC Jr, Henn S, Hinestrosa F, Huynh C, McDonald C, Mills A, Overton ET, Ramgopal M, Rashbaum B, Ray G, Scarsella A, Yozviak J, McPhee F, Liu Z, Hughes E, Yin PD, Noviello S, Ackerman P; ALLY-2 Investigators. Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1. N Engl J Med. 2015 Aug 20;373(8):714-25. doi: 10.1056/NEJMoa1503153. Epub 2015 Jul 21.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Samah A Loutfy study director
National Cancer Institute, Cairo University, Cairo, Egypt
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Zagazig University.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 10 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Negida (+201125549087, ahmed01251@medicine.zu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy measured by Sustained Virologic Response Rate (time frame: 12 weeks posttreatment). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02772744, which also lists 3 linked publications.
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 10 Oct 2017.