Determining the Sustained Virologic Response of Declatasvir in Egyptian Patients With Hepatitis C Virus Genotype 4
NCT ID: NCT02772744
Last Updated: 2017-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
250 participants
OBSERVATIONAL
2017-11-01
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Daclatasvir 60 MG Oral Tablet [Daklinza]
Daclatasvir (60 MG) is a potent, pan-genotypic inhibitor of the HCV NS5A protein
Sofosbuvir 400 MG Oral Tablet [Sovaldi]
Sofosbuvir (400 MG) is a nucleotide analogue HCV NS5B polymerase inhibitor
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.
Daclatasvir 60 MG Oral Tablet [Daklinza]
Daclatasvir (60 MG) is a potent, pan-genotypic inhibitor of the HCV NS5A protein
Sofosbuvir 400 MG Oral Tablet [Sovaldi]
Sofosbuvir (400 MG) is a nucleotide analogue HCV NS5B polymerase inhibitor
Ribavirin Oral Product
Ribavirin (twice-daily) dosed according to body weight (\<75 kg, 1000 mg daily; ≥75 kg, 1200 mg daily)
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.
Daclatasvir 60 MG Oral Tablet [Daklinza]
Daclatasvir (60 MG) is a potent, pan-genotypic inhibitor of the HCV NS5A protein
Sofosbuvir 400 MG Oral Tablet [Sovaldi]
Sofosbuvir (400 MG) is a nucleotide analogue HCV NS5B polymerase inhibitor
Ribavirin Oral Product
Ribavirin (twice-daily) dosed according to body weight (\<75 kg, 1000 mg daily; ≥75 kg, 1200 mg daily)
Interventions
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Daclatasvir 60 MG Oral Tablet [Daklinza]
Daclatasvir (60 MG) is a potent, pan-genotypic inhibitor of the HCV NS5A protein
Sofosbuvir 400 MG Oral Tablet [Sovaldi]
Sofosbuvir (400 MG) is a nucleotide analogue HCV NS5B polymerase inhibitor
Ribavirin Oral Product
Ribavirin (twice-daily) dosed according to body weight (\<75 kg, 1000 mg daily; ≥75 kg, 1200 mg daily)
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* HCV RNA≥ 104 IU/mL
* Screening ECG without clinically significant abnormalities.
Exclusion Criteria
* 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%).
18 Years
ALL
No
Sponsors
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Cairo University
OTHER
Zagazig University
OTHER_GOV
Responsible Party
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Ahmed Negida
Mr.
Principal Investigators
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Samah A Loutfy
Role: STUDY_DIRECTOR
National Cancer Institute, Cairo University, Cairo, Egypt
Central Contacts
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References
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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.
Hezode 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.
Wyles 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 Links
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Other Identifiers
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2667-20-3-2016
Identifier Type: -
Identifier Source: org_study_id