Determining the Sustained Virologic Response of Declatasvir in Egyptian Patients With Hepatitis C Virus Genotype 4

Hepatitis C Clinical Trial

Official title:

Determining the Sustained Virologic Response of Declatasvir in Egyptian Patients With Hepatitis C Virus Genotype 4

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02772744
• Other study ID #: 2667-20-3-2016
• Status: Not yet recruiting
• Phase: N/A
• First received: March 24, 2016
• Last updated: October 8, 2017
• Start date: November 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: October 2017
• Source: Zagazig University
• Contact: Ahmed Negida
• Phone: +201125549087
• Email: ahmed01251[@]medicine.zu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with HCV genotype 4

• Age = 18 years

• HCV RNA= 104 IU/mL

• Screening ECG without clinically significant abnormalities.

Exclusion Criteria:

• 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%).

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Zagazig University	Cairo University

References & Publications (3)

Hézode C, Alric L, Brown A, Hassanein T, Rizzetto M, Buti M, Bourlière 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. [Epub ahead of print] — View Citation

Jensen D, Sherman KE, Hézode 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy measured by Sustained Virologic Response Rate		12 weeks posttreatment
Primary	Incidence of grade 3/4 adverse events [Safety]		Within the treatment period (12 or 24 weeks according to the treatment regimen)
Primary	Incidence of Neutropenia [Safety]	Neutropenia: Grade 3, 500-749/mm3; Grade 4, <500/mm3	Within the treatment period (12 or 24 weeks according to the treatment regimen)
Primary	Incidence of Lymphopenia [Safety]	Lymphopenia: Grade 3, 350-499/mm3; Grade 4, <350/mm3	Within the treatment period (12 or 24 weeks according to the treatment regimen)
Primary	Incidence of anaemia [Safety]	Anaemia: Grade 3, haemoglobin 7.0-8.9 g/dL; Grade 4, <7.0 g/dL	Within the treatment period (12 or 24 weeks according to the treatment regimen)
Primary	Incidence of Thrombocytopenia [Safety]	Thrombocytopenia: Grade 3, 25 000-49 999/mm3; Grade 4, <25 000/mm3	Within the treatment period (12 or 24 weeks according to the treatment regimen)
Primary	Incidence of (Increased total Bilirubin) [Safety]	Bilirubin elevations: Grade 3, 2.6-5×ULN; Grade 4, >5×ULN	Within the treatment period (12 or 24 weeks according to the treatment regimen)
Primary	Incidence of elevated Alanine Aminotransferase [Safety]	Alanine Aminotransferase elevations: Grade 3, 5.1-10×upper limit of normal (ULN); Grade 4, >10×ULN	Within the treatment period (12 or 24 weeks according to the treatment regimen)
Primary	Incidence of Fatigue [Safety]		Within the treatment period (12 or 24 weeks according to the treatment regimen)
Primary	Incidence of Headache [Safety]		Within the treatment period (12 or 24 weeks according to the treatment regimen)
Primary	Incidence of Pruritus [Safety]		Within the treatment period (12 or 24 weeks according to the treatment regimen)
Primary	Incidence of Insomnia [Safety]		Within the treatment period (12 or 24 weeks according to the treatment regimen)
Primary	Incidence of Rash [Safety]		Within the treatment period (12 or 24 weeks according to the treatment regimen)
Primary	Incidence of Nausea [Safety]		Within the treatment period (12 or 24 weeks according to the treatment regimen)
Primary	Incidence of Myalgia [Safety]		Within the treatment period (12 or 24 weeks according to the treatment regimen)
Secondary	Health Related Quality of Life (HRQoL)	HRQoL will be assessed using the Arabic version of SF-36 questionnaire (SF-36™ Health Survey)	24 weeks

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