Assessment Effects After Direct Acting Antiviral in Chronic Hepatitis c Virus Patients

NCT03163849 | Unknown Phase 3

• 1 other identifier: PRHCV
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

Chronic hepatitis C virus infection affects an estimated one hundred and seventy million people around the world with and approximate prevalence 0.2-2 % in the United State of America and European countries.

Conditions

Chronic Hepatitis c

Outcome Measures

Primary Outcomes (2)

• the percentage of patients with hematological changes

  complete blood count and prothrombin time and concentration

  12 weeks

• The percentage of patients with antibodies against RBCs

  Coomb's test

  Pre treatment

Secondary Outcomes (2)

• the percentage of patients with biochemical changes

  12 weeks

• The percentage of patients with antibodies against RBCs

  Three months after the end of treatment

Study Arms (2)

control group

PLACEBO COMPARATOR

oral tablets

Drug: Placebos

Study group

EXPERIMENTAL

sofosbuvir , daclatasvir oral tablets

Drug: Sofosbuvir , daclatasvir

Interventions

Sofosbuvir , daclatasvir DRUG

Tablets

Study group

Placebos DRUG

oral tablets

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Our study proposed for all consented patients complaining from chronic Hepatitis C virus infection undergoing treatment with antiviral drugs is possible through certain indications or criteria as follow:
• Patients with chronic Hepatitis C virus who are candidates for Direct Acting Antiviral Therapy:
• Age is from 18 to 65 years.

You may not qualify if:

• Those patients with chronic Hepatitis C virus infection are impossible or contraindicated to be treated with antiviral drugs as follow: - Geriatrics (\> 65 years of age): - Pediatrics (\< 18 years of age): - patients with known hypersensitivity to any of the components of the antiviral drug.
• Post-Liver Transplant Patients. ـPatients with primary haematological abnormalities not related to chronic hepatitis C virus infection
• Experienced patients (previously failed treatment)

Sponsors & Collaborators

• Assiut University: lead

Study Sites (2)

Assuit

Asyut, Assuit, Egypt

Location

Assuit

Asyut, Egypt

Location

Related Publications (10)

• Esteban JI, Sauleda S, Quer J. The changing epidemiology of hepatitis C virus infection in Europe. J Hepatol. 2008 Jan;48(1):148-62. doi: 10.1016/j.jhep.2007.07.033. Epub 2007 Nov 5.

  PMID: 18022726 BACKGROUND

• Lavanchy D. The global burden of hepatitis C. Liver Int. 2009 Jan;29 Suppl 1:74-81. doi: 10.1111/j.1478-3231.2008.01934.x.

  PMID: 19207969 BACKGROUND

• Darwish NM, Abbas MO, Abdelfattah FM, Darwish MA. Hepatitis C virus infection in blood donors in Egypt. J Egypt Public Health Assoc. 1992;67(3-4):223-36.

  PMID: 1296960 BACKGROUND

• Fallahian F, Najafi A. Epidemiology of hepatitis C in the Middle East. Saudi J Kidney Dis Transpl. 2011 Jan;22(1):1-9.

  PMID: 21196607 BACKGROUND

• El-Serag HB, Mason AC. Rising incidence of hepatocellular carcinoma in the United States. N Engl J Med. 1999 Mar 11;340(10):745-50. doi: 10.1056/NEJM199903113401001.

  PMID: 10072408 BACKGROUND

• Davis GL, Albright JE, Cook SF, Rosenberg DM. Projecting future complications of chronic hepatitis C in the United States. Liver Transpl. 2003 Apr;9(4):331-8. doi: 10.1053/jlts.2003.50073.

  PMID: 12682882 BACKGROUND

• Verna EC, Brown RS Jr. Hepatitis C virus and liver transplantation. Clin Liver Dis. 2006 Nov;10(4):919-40. doi: 10.1016/j.cld.2006.08.012.

  PMID: 17164125 BACKGROUND

• Khan G, Hashim MJ. Burden of virus-associated liver cancer in the Arab world, 1990-2010. Asian Pac J Cancer Prev. 2015;16(1):265-70. doi: 10.7314/apjcp.2015.16.1.265.

  PMID: 25640363 BACKGROUND

• Operskalski EA, Kovacs A. HIV/HCV co-infection: pathogenesis, clinical complications, treatment, and new therapeutic technologies. Curr HIV/AIDS Rep. 2011 Mar;8(1):12-22. doi: 10.1007/s11904-010-0071-3.

  PMID: 21221855 BACKGROUND

• Chayama K, Hayes CN. HCV Drug Resistance Challenges in Japan: The Role of Pre-Existing Variants and Emerging Resistant Strains in Direct Acting Antiviral Therapy. Viruses. 2015 Oct 13;7(10):5328-42. doi: 10.3390/v7102876.

  PMID: 26473914 BACKGROUND

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Sofosbuvir; daclatasvir

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Sahar Ali, Master Degree

  Internal medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 23, 2017
• Study Start: September 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: July 30, 2020
• Last Updated: September 12, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)