NCT03283176

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

September 12, 2017

Last Update Submit

October 14, 2020

Conditions

Liver CirrhosesChronic Hepatitis cDirectly Acting Antivirals

Outcome Measures

Primary Outcomes (2)

  • Vitamin B12

    By ELISA Technique, in Pg/ml

    1 year

  • Folic Acid

    By ELISA technique, in Pg/ml

    1 year

Study Arms (2)

Sofo-Dacla with Ribavirin

Chronic Hepatitis C related Liver Cirrhosis patients who will take sofosbuveir, Daclatasvir with Ribavirin

Diagnostic Test: Vitamin B12 and Folic Acid

Sofo-Dacla without Ribavirin

Chronic Hepatitis C related Liver Cirrhosis patients who will take sofosbuveir, Daclatasvir without Ribavirin

Diagnostic Test: Vitamin B12 and Folic Acid

Interventions

Vitamin B12 and Folic AcidDIAGNOSTIC_TEST

Vitamin B12 and Folic Acid measurement by ELISA technique

Sofo-Dacla with RibavirinSofo-Dacla without Ribavirin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Fifty patients were diagnosed to have HCV-related liver cirrhosis and candidate for anti- HCV therapy

You may qualify if:

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

You may not qualify if:

  • Chronic hepatitis due causes other than chronic HCV infection
  • Coinfection with HIV or HBV infection
  • Hepatocellular carcinoma
  • Decompensated cirrhosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Shaban Redwan Helal

Asyut, 71111, Egypt

Location

Related Publications (5)

  • 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. No abstract available.

    PMID: 19330875BACKGROUND

  • 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. doi: 10.1053/gast.2003.50061.

    PMID: 12557141BACKGROUND

  • 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.

    PMID: 22430955BACKGROUND

  • Ampuero J, Romero-Gomez M, Reddy KR. Review article: HCV genotype 3 - the new treatment challenge. Aliment Pharmacol Ther. 2014 Apr;39(7):686-98. doi: 10.1111/apt.12646.

    PMID: 24612116BACKGROUND

  • Qamar AA, Grace ND. Abnormal hematological indices in cirrhosis. Can J Gastroenterol. 2009 Jun;23(6):441-5. doi: 10.1155/2009/591317.

    PMID: 19543577BACKGROUND

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor at Tropical Medicine and Gastroenterology Department

Study Record Dates

First Submitted

September 12, 2017

First Posted

September 14, 2017

Study Start

March 1, 2018

Primary Completion

March 1, 2019

Study Completion

January 14, 2020

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)