Hematologic Profile, Vit. B12 and Folic Acid in Cirrhotics Received Sofosbuvir and Daclatasvir With or Without Ribavirin

Chronic Hepatitis c Clinical Trial

Official title:

Changes in Hematologic Profile, Vitamin B12 and Folic Acid Level in Cirrhotic Patients Received Sofosbuvir and Daclatasvir With or Without Ribavirin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03283176
• Other study ID #: Haematological Prof. in DAAs
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: January 14, 2020

Study information

• Verified date: October 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Use of Ribavirin could affect hematologic profile of the patients negatively. With advent of new antiviral therapy, the preexisting hematologic changes may alter or corrected after treatment. However, this point is still not properly studied.

Description:

Hepatitis C virus (HCV) infection is a global health problem that affects 170 million people worldwide, and approximately 55% (95 million) of the infected population is in South East Asia and Western Pacific countries.

Hepatitis C virus (HCV) is considered one of the main causes of chronic hepatitis and also may be complicated by serious complications as liver cirrhosis, ascites and hepatocellular carcinoma. It is also, one of the leading indications for liver transplantation (LT) in adults around the world.

Abnormalities in hematological parameters are common in patients with cirrhosis. The pathogenesis of abnormal hematological indices (HIs) in cirrhosis is multifactorial and includes portal hypertension-induced sequestration, alterations in bone marrow stimulating factors, viral- and toxin-induced bone marrow suppression and consumption or loss. Abnormalities in HIs are associated with an increased risk of complications including bleeding and infection.

So, early recognition and early treatment of those patients with chronic HCV infection can modify its natural history. There are many factors affecting the outcome of HCV infection as viral, environmental and host factors, including immunologic and genetic susceptibilities.

Till 2011, the main lines of therapy were Interferon plus ribavirin for at least 48 weeks but these combinations was associated with low incidence of Sustained Virological Response (SVR). Now, there is era of Direct Acting Analogues that used for treatment of patients with chronic HCV infection and associated with high rate of SVR.

Daclatasvir is a first-in-class HCV NS5A replication complex inhibitor, and Sofosbuvir is a nucleotide analogue HCV NS5B polymerase inhibitor. Both have potent antiviral activity and broad genotypic coverage and are administered orally once daily.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 14, 2020
• Est. primary completion date: March 1, 2019
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients known to have HCV-related liver cirrhosis and candidate for therapy with Sofosbuvir and Daclatasvir with or without Ribavirin

Exclusion Criteria:

• Chronic hepatitis due causes other than chronic HCV infection

• Coinfection with HIV or HBV infection

• Hepatocellular carcinoma

• Decompensated cirrhosis

Related Conditions & MeSH terms

• Chronic Hepatitis c
• Directly Acting Antivirals
• Hepatitis C
• Hepatitis C, Chronic
• Liver Cirrhoses
• Liver Cirrhosis

Intervention

Diagnostic Test:
• Vitamin B12 and Folic Acid
Vitamin B12 and Folic Acid measurement by ELISA technique

Locations

Country	Name	City	State
Egypt	Mohamed Shaban Redwan Helal	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Ampuero J, Romero-Gómez M, Reddy KR. Review article: HCV genotype 3 - the new treatment challenge. Aliment Pharmacol Ther. 2014 Apr;39(7):686-98. Review. — View Citation

Ghany MG, Strader DB, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology. 2009 Apr;49(4):1335-74. doi: 10.1002/hep.22759. — View Citation

Lam AM, Espiritu C, Bansal S, Micolochick Steuer HM, Niu C, Zennou V, Keilman M, Zhu Y, Lan S, Otto MJ, Furman PA. Genotype and subtype profiling of PSI-7977 as a nucleotide inhibitor of hepatitis C virus. Antimicrob Agents Chemother. 2012 Jun;56(6):3359-68. doi: 10.1128/AAC.00054-12. Epub 2012 Mar 19. — View Citation

Promrat K, McDermott DH, Gonzalez CM, Kleiner DE, Koziol DE, Lessie M, Merrell M, Soza A, Heller T, Ghany M, Park Y, Alter HJ, Hoofnagle JH, Murphy PM, Liang TJ. Associations of chemokine system polymorphisms with clinical outcomes and treatment responses of chronic hepatitis C. Gastroenterology. 2003 Feb;124(2):352-60. Erratum in: Gastroenterology. 2003 Apr;124(4):1168.. — View Citation

Qamar AA, Grace ND. Abnormal hematological indices in cirrhosis. Can J Gastroenterol. 2009 Jun;23(6):441-5. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin B12	By ELISA Technique, in Pg/ml	1 year
Primary	Folic Acid	By ELISA technique, in Pg/ml	1 year