NCT03882307

Brief Summary

Hepatitis C virus (HCV) infection is associated with significant morbidity and mortality owing to progression of a high percentage (85%) of HCV infected patients to chronic hepatitis, which might lead to the development of liver cirrhosis or hepato cellular carcinoma.. Egypt has possibly the highest HCV prevalence in the world, 10-20% of the general population .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Oct 2022

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

March 15, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 20, 2019

Completed
3.5 years until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

1 month

First QC Date

March 15, 2019

Last Update Submit

July 25, 2022

Conditions

Hepatitis C, Chronic

Keywords

hepatitis C virus therapyinterleukin-6transforming growth factor -betasustained virological response

Outcome Measures

Primary Outcomes (1)

  • mean difference in level of interleukin-6 and transforming growth factor beta after treatment

    serum level of interleukin-6 and transforming growth factor beta will be measured before and after treatment

    three months from the end of treatment

Study Arms (2)

group1 (naive)

NO INTERVENTION

Assess serum level of interleukin-6 and transforming growth factor beta before the course of treatment

group2 (sustained responder)

ACTIVE COMPARATOR

Assess serum level of interleukin-6 and transforming growth factor beta after three months from the end of treatment Sofosbuvir (SOF) (400 mg once per day) and daclatasvir (DCV)(60mg once per day) or simeprevir (SIM) (150 mg once per day) for 3 months treatment regimens

Drug: sofosbuvir and daclatasvir

Interventions

sofosbuvir and daclatasvirDRUG

oral tablets

Also known as: Sovaldi
group2 (sustained responder)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age from 18 to 70 years.
  • HCV RNA positivity .
  • Any Body Mass Index(BMI).
  • Treatment-naive or treatment experienced.
  • all fibrosis stages.

You may not qualify if:

  • Direct serum bilirubin greater than 2 mg/dl.
  • Serum albumin less than 2.8 g/dl.
  • International normalization ratio (INR) greater than or equal to 1.7
  • Platelet count less than 50 000/mm3.
  • Ascites or history of ascites.
  • Hepatic encephalopathy or history of hepatic encephalopathy.
  • Hepatocellular carcinoma.
  • Serum creatinine greater than 2.5 mg/dl .
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

RECRUITING

Related Publications (7)

  • Rahman El-Zayadi A, Abaza H, Shawky S, Mohamed MK, Selim OE, Badran HM. Prevalence and epidemiological features of hepatocellular carcinoma in Egypt-a single center experience. Hepatol Res. 2001 Feb;19(2):170-179. doi: 10.1016/s1386-6346(00)00105-4.

    PMID: 11164741BACKGROUND

  • Sulkowski MS, Gardiner DF, Rodriguez-Torres M, Reddy KR, Hassanein T, Jacobson I, Lawitz E, Lok AS, Hinestrosa F, Thuluvath PJ, Schwartz H, Nelson DR, Everson GT, Eley T, Wind-Rotolo M, Huang SP, Gao M, Hernandez D, McPhee F, Sherman D, Hindes R, Symonds W, Pasquinelli C, Grasela DM; AI444040 Study Group. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med. 2014 Jan 16;370(3):211-21. doi: 10.1056/NEJMoa1306218.

    PMID: 24428467BACKGROUND

  • Baskic D, Vukovic VR, Popovic S, Djurdjevic P, Zaric M, Nikolic I, Zelen I, Mitrovic M, Avramovic D, Mijailovic Z. Cytokine profile in chronic hepatitis C: An observation. Cytokine. 2017 Aug;96:185-188. doi: 10.1016/j.cyto.2017.04.008. Epub 2017 Apr 21.

    PMID: 28433893BACKGROUND

  • Heinrich PC, Castell JV, Andus T. Interleukin-6 and the acute phase response. Biochem J. 1990 Feb 1;265(3):621-36. doi: 10.1042/bj2650621. No abstract available.

    PMID: 1689567BACKGROUND

  • Ueyama M, Nakagawa M, Sakamoto N, Onozuka I, Funaoka Y, Watanabe T, Nitta S, Kiyohashi K, Kitazume A, Murakawa M, Nishimura-Sakurai Y, Sekine-Osajima Y, Itsui Y, Azuma S, Kakinuma S, Watanabe M; Ochanomizu-Liver Conference Study Group. Serum interleukin-6 levels correlate with resistance to treatment of chronic hepatitis C infection with pegylated-interferon-alpha2b plus ribavirin. Antivir Ther. 2011;16(7):1081-91. doi: 10.3851/IMP1864.

    PMID: 22024524BACKGROUND

  • Bissell DM, Wang SS, Jarnagin WR, Roll FJ. Cell-specific expression of transforming growth factor-beta in rat liver. Evidence for autocrine regulation of hepatocyte proliferation. J Clin Invest. 1995 Jul;96(1):447-55. doi: 10.1172/JCI118055.

    PMID: 7615817BACKGROUND

  • Liaskou E, Wilson DV, Oo YH. Innate immune cells in liver inflammation. Mediators Inflamm. 2012;2012:949157. doi: 10.1155/2012/949157. Epub 2012 Aug 9.

    PMID: 22933833BACKGROUND

Related Links

MeSH Terms

Conditions

Hepatitis C, ChronicCamurati-Engelmann Syndrome

Interventions

Sofosbuvirdaclatasvir

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsOsteochondrodysplasiasBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Uridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • hayam hamdy, master deree

    faculty of medicine,medical microbiology department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Salwa Sayed Ahmed, proffessor

CONTACT

01013318344salwaegy@yahoo.com

Aliaa Mahmoud Ali, lecturer

CONTACT

01006199196aliaaghandour@yahoo.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: assess serum level of interleukin-6 and transforming growth factor beta before intervention and after intervention with sofosbuvir and daclatasvir.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

March 15, 2019

First Posted

March 20, 2019

Study Start

October 1, 2022

Primary Completion

November 1, 2022

Study Completion

December 1, 2022

Last Updated

July 26, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Serum concentrations of(IL-6 and TGF-β) will be measured before treatment and after three months from the end of the course of treatment with sofosbuvir 400 mg once daily plus daclatasvir 60 mg for three months using a commercially available Quanti kine ELISA (Enzyme linked Immune sorbent Assay ).

Locations

EG(1)