Clinical trial NCT02772744: Determining the Sustained Virologic Response of Declatasvir in Egyptian Patients With Hepatitis C Virus Genotype 4
Official title: Determining the Sustained Virologic Response of Declatasvir in Egyptian Patients With Hepatitis C Virus Genotype 4
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C
Keywords: Hepatitis C virus genotype 4
Antiviral
Virologic Response
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
Collaborators: name: Cairo University
First posted: 2016-05-13
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.


Eligibility criteria: 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%).

Primary outcomes:
measure: Efficacy measured by Sustained Virologic Response Rate
timeFrame: 12 weeks posttreatment
measure: Incidence of grade 3/4 adverse events [Safety]
timeFrame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
measure: Incidence of Neutropenia [Safety]
timeFrame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
measure: Incidence of Lymphopenia [Safety]
timeFrame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
measure: Incidence of anaemia [Safety]
timeFrame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
measure: Incidence of Thrombocytopenia [Safety]
timeFrame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
measure: Incidence of (Increased total Bilirubin) [Safety]
timeFrame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
measure: Incidence of elevated Alanine Aminotransferase [Safety]
timeFrame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
measure: Incidence of Fatigue [Safety]
timeFrame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
measure: Incidence of Headache [Safety]
timeFrame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
measure: Incidence of Pruritus [Safety]
timeFrame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
measure: Incidence of Insomnia [Safety]
timeFrame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
measure: Incidence of Rash [Safety]
timeFrame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
measure: Incidence of Nausea [Safety]
timeFrame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
measure: Incidence of Myalgia [Safety]
timeFrame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
Secondary outcomes:
measure: Health Related Quality of Life (HRQoL)
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: National Cancer Institute, Cairo University, Cairo, Egypt
name: Samah A Loutfy
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
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.