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Hepatitis C, ChronicEarly Phase 1NCT03882307

Levels of Interleukin-6 andTransforming Growth Factor Beta in HCV Patients Sera

A Early Phase 1 study testing sofosbuvir and daclatasvir in people with Hepatitis C, Chronic, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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.. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
sofosbuvir and daclatasvir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
Oct 2022to Dec 2022
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 9Show fewer
  • Hepatocellular carcinoma.
  • Serum creatinine greater than 2.5 mg/dl .
  • Pregnancy.

Trial locations and contacts

1 site in 1 country.

Salwa Sayed Ahmed, proffessor contact

01013318344

salwaegy@yahoo.com

Aliaa Mahmoud Ali, lecturer contact

01006199196

aliaaghandour@yahoo.com

Egypt1 site, 1 recruiting

  • Assiut university

    Asyut

    Assiut University, 01003826774, Hayamhamdy@Med.aun.edu.eg

    Hayam Hamdy, 01003826774, Hayamhamdy@Med.aun.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Association of Serum Interleukin -6 and Transforming Growth Factor Beta Levels With Response to Antiviral Therapy for Chronic Hepatitis c Patients

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 .

Read the detailed description

Currently, second-generation direct-acting antiviral agents have been used for chronic hepatitis C treatment. The association of sofosbuvir with daclatasvir or simeprevir , with or without ribavirin , directly inhibits viral replication .

Sofosbuvir (400 mg once per day) and daclatasvir (60mg once per day) or simeprevir (150 mg once per day) for 3 months treatment regimens.

Sofosbuvir-based antiviral therapy guarantees efficacy in HCV eradication in approximately 90% of cases and is associated with mild to moderate adverse effects.

Overall, studies describe an increase in serum cytokine levels in chronic hepatitis C patients, when compared with healthy individuals. ,interleukin-6(IL-6) is produced mainly by kupffer cells and induces the production of the acute phase proteins, C-reactive protein and haptoglobin .

Previous studies reported that serum Interleukin-6 levels were increased, compared with healthy individuals, in patients with some liver diseases.Previous results suggest that baseline levels of Interleukin, as well as their decrease during treatment .Transforming growth factor beta (TGF-β) is a cytokine that has been assigned a key role in epithelial repair. Injury to the liver elicits a rapid increase in its expression. HCV -infected hepatocytes produce (TGF-β) which may stimulate T-regulatory cells.

Being tested
sofosbuvir and daclatasvir
Keywords
hepatitis C virus therapy, interleukin-6, transforming growth factor -beta, sustained virological response
Medical subject headings
Hepatitis C, Chronic, Camurati-Engelmann Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sofosbuvir and daclatasvirDrug

    Also called Sovaldi

    oral tablets

Study groups in NCT03882307
Study groupRoleWhat they receive
group1 (naive)No interventionAssess serum level of interleukin-6 and transforming growth factor beta before the course of treatment
group2 (sustained responder)Active comparatorAssess 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
Receives: Drug: sofosbuvir and daclatasvir

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: three months from the end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2019
  2. Study startOct 2022 (estimated)
  3. Primary completionNov 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
assess serum level of interleukin-6 and transforming growth factor beta before intervention and after intervention with sofosbuvir and daclatasvir.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03882307
Sponsor's protocol ID
hhayam
Status last verified
Jul 2022
First submitted
15 Mar 2019
Last updated
26 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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 ).

Publications

  • 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.

    PubMed 11164741

  • 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.

    PubMed 24428467

  • 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.

    PubMed 28433893

  • 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.

    PubMed 1689567

  • 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.

    PubMed 22024524

  • 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.

    PubMed 7615817

  • 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.

    PubMed 22933833

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing sofosbuvir and daclatasvir in people with Hepatitis C, Chronic, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Salwa Sayed Ahmed, proffessor (01013318344, salwaegy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mean difference in level of interleukin-6 and transforming growth factor beta after treatment (time frame: three months from the end of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03882307, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.

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