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AzTrials

Hepatitis CNCT03241823

Assessment of Patients With Hepatitis C Virus Related Liver Cirrhosis After Sustained Response to Direct Acting Anti Viral Drugs.

An observational study of Hepatitis C and Liver Cirrhosis, 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 The sponsor has not verified this record for over two years, so it may be out of date.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 a major global health challenge; it is estimated that more than 80 million people are chronically infected worldwide, with 3-4 million new infections and 350,000 deaths occurring each year because of HCV-related complications . Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, Liver Cirrhosis
What is being tested?
Abdominal ultrasound ., Model for End-Stage Liver Disease and Fibro Scan.
How many people
100 participants
Where
1 siteEgypt
Study dates
1 Dec 2017to Mar 2019
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 100 patients with chronic hepatitis C virus related liver cirrhosis who achieved Sustained virological response after direct acting antiviral drugs (Sofosbuvir, Daclatasvir ± Ribavirin) and other available suitable regimens for 12 or 24 weeks will be selected from Assuit unit of treatment of viral hepatitis.

Who may be able to join

  • Age: ≥ 18 years.
  • Disease status: patients with hepatitis C Virus related liver cirrhosis child A\& B (scores 5-9).
  • Previous treatment: treatment naïve and treatment experienced.
  • HCV RNA: Negative at any point between 12-24 weeks post treatment to confirm successful eradication of the virus.
  • Negative HBsAg and HIV antibody.
  • Normal kidney function test

Who cannot join

  • Child C liver cirrhosis (Child score ≥ 10).
  • HCV coinfection with HBV or HIV.
  • Patients with high risk of infection (I.V drug users, patients with blood disease requiring blood transfusion).

Trial locations and contacts

1 site in 1 country.

Sahar Hassany, MD contact

00201010431017

saharhassany@yahoo.com

Egypt1 site
  • Assuit Unit of Treatment of Viral Hepatitis.

    Asyut, 71111

    Waleed Hassan, MD, 00201020066191, wallo403a@yahoo.com

Other trials in Egypt

About this study

Official title: Assessment of Hepatic Fibrosis, Hemodynamics, and Disease Severity of Patients With Hepatitis C Virus Related Liver Cirrhosis After Sustained Response to Direct Acting Anti Viral Drugs.

Hepatitis C Virus (HCV) infection is a major global health challenge; it is estimated that more than 80 million people are chronically infected worldwide, with 3-4 million new infections and 350,000 deaths occurring each year because of HCV-related complications .

Read the detailed description

In 2015, a national Egyptian health issue survey was conducted to describe the prevalence of hepatitis C virus infection. The prevalence of hepatitis C virus antibody was found to be 10.0% and that of Hepatitis C virus Ribonucleic acid (HCV RNA ) to be 7.0% in the age group between 15-59 years. While In children, 1-14 years old, the prevalence of Hepatitis C virus (HCV) antibody and Hepatitis C virus Ribonucleic acid (HCV RNA) were 0.4% and 0.2% respectively.

The primary goal of HCV therapy is to cure the infection, i.e. to achieve a sustained virological response (SVR) defined as undetectable Hepatitis C virus Ribonucleic acid (HCV RNA )12 weeks or 24 weeks after treatment completion. The infection is cured in more than 99% of patients who achieve asustained virological response (SVR). Asustained virological response (SVR) is generally associated with normalization of liver enzymes and improvement or disappearance of liver necroinflammation and fibrosis in patients without cirrhosis. Patients with severe liver disease remain at risk of life-threatening complications; however hepatic fibrosis may regress and the risk of complications such as hepatic failure and portal hypertension is reduced .

Previous data suggest that the risk of Hepatocellular carcinoma and all-cause mortality is significantly reduced, but not eliminated, in cirrhotic patients who clear Hepatitis C Virus compared to untreated patients and non-sustained virological responders . Hepatitis C Virus is also associated with a number of extrahepatic manifestations and effective viral suppression induces reversal of most of them .

Studies in those with hepatitis C-related decompensated cirrhosis have demonstrated that sustained virological response can indeed be achieved in the majority of these individuals, and short-term follow-up from these studies has shown that Sustained virological response is often accompanied by improvement in measures of decompensation including Model for End-Stage Liver Disease (MELD) score and Child-Turcotte-Pugh (CPT) score. Moreover, because hepatitis C recurrence after Orthotopic liver transplantation is associated with worse outcomes, achieving Sustained virological response before transplant in a decompensated population with chronic hepatitis C will likely allow these patients to achieve long-term outcomes not different from non-Hepatitis C virus-infected populations .

In the SOLAR-1 and SOLAR-2 studies, those with decompensated cirrhosis with genotypes 1 and 4 were randomized to receive sofosbuvir/ledipasvir with low-dose ribavirin for 12 or 24 weeks . No difference was seen in Sustained virological response in the 12- or 24-week arms, and the therapy was well tolerated. Moreover, these studies both reported improvement in Model for End-Stage Liver Disease (MELD) score and Child-Turcotte-Pugh (CPT) scores 4 weeks after therapy had been stopped with longer-term follow-up results expected.

Liver stiffness measurement by transient elastography is a noninvasive, painless, rapid, and objective method for the evaluation of fibrosis or cirrhosis . Systemic reviews and meta-analyses have demonstrated the high sensitivity and specificity of Liver stiffness measurement in the diagnosis of hepatic cirrhosis.

In a systematic review conducted at 2007, repoted that at a threshold of approximately 0.60, the sensitivity and specificity of the FibroTest were 47% (35-59%) and 90% (87-92%). For FibroScan (threshold approximately 8 kPa), corresponding values were 64% (50-76%) and 87% (80-91%), respectively.

In another systematic review conducted at 2010, reported that the pooled estimates for sensitivity of fibroscan were 87% (84%-90%), specificity 91% (89%-92%) in stage IV fibrosis (cirrhosis). While in patients with stages II-IV fibrosis, they reported that the pooled estimates for sensitivity were 70% (67%-73%), specificity 84% (80%-88%).

Multicenter observational, cohort, prospective study included 90 patients with hepatitis C genotype 1 treated with telaprevir or boceprevir who had advanced fibrosis evidenced by liver stiffness and achieved Sustained virological response reported that liver stiffness was significantly reduced 2 weeks after treatment. This suggested the possibility of liver cirrhosis regression evidenced by liver stiffness after sustained virological response in a significant proportion of patients .

In a study included 182 Egyptian patients with HCV infection to validate and compare the diagnostic performance of Fibroscan , APRI Score , FIB4 for the prediction of hepatic fibrosis and treatment outcome in HCV infected patients receiving pegylated interferon and ribavirin, the authors reported that Fibroscan and noninvasive scores as APRI , FIB4 can be used as good predictors of liver fibrosis in chronic hepatitis C. However, they are not good predictors of response to pegylated interferon and ribavirin .

In a study 2010, they concluded that liver stiffness measurement can be useful for monitoring regression of liver fibrosis during entecavir treatment in patients with chronic hepatitis B virus infection.

A few studies showed a consistent relationship between Doppler Ultrasonography findings and liver histology. showed that Doppler Ultrasound findings are sensitive to haemo dynamic changes in liver fibrosis. Doppler Ultrasonography scoring was significantly related to liver fibrosis staging.

The Doppler Ultrasound signs for portal hypertension are: (1) reduced portal vein blood flow velocity (time-averaged mean vel. < 14-16 cm/s2), with sensitivity and specificity between 80-88% and 80-96%, respectively; (2) portal vein congestion index > 0.08. This parameter, however, is not used routinely, probably due to its being difficult to measure and its lower reproducibility; and (3) measurements of the hepatic arterial Resistive Index are less useful. In the course of Liver cirrhosis, the appearance of clinically significant portal hypertension worsens prognosis and Doppler ultrasound is very useful in evaluating portal hypertension. . astudy showed a significant reverse correlation between the velocities of the main portal vein and fibrous staging of the liver.

Being tested
Abdominal ultrasound ., Model for End-Stage Liver Disease, Fibro Scan., Child-Turcotte-Pugh score.
Medical subject headings
Hepatitis C, Liver Cirrhosis

What participants receive

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

  • Abdominal ultrasound .Diagnostic test

    Abdominal ultrasound for each patient before and after treatment.

  • Model for End-Stage Liver DiseaseDiagnostic test

    Model for End-Stage Liver Disease before and after treatment.

  • Fibro Scan.Diagnostic test

    Liver stiffness by Fibro scan before and after treatment.

  • Child-Turcotte-Pugh score.Diagnostic test

    Child-Turcotte-Pugh score before and after treatment

Study groups in NCT03241823
Study groupRoleWhat they receive
Patients with hepatitis c virus related liver cirrhosisPatients with chronic hepatitis C virus whose ultrasound shows liver cirrhosis, fibroscan "F3 and F4, Child score "A and B", of any MELD score, who achieved Sustained Virological Response after direct acting antiviral drugs (Sofosbuvir, Daclatasvir ± Ribavirin).
Receives: Diagnostic Test: Abdominal ultrasound .; Diagnostic Test: Model for End-Stage Liver Disease; Diagnostic Test: Fibro Scan.; Diagnostic Test: Child-Turcotte-Pugh score.

What is being measured

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

  1. Changes in liver fibrosis

    Using non-invasive measures "Fibroscan"

    Measured: 1 year.

Secondary outcomes (2)
  1. Changes occurring in liver haemodynamics

    Using Doppler ultrasound.

    Measured: 1 year.

  2. Changes in severity of liver disease

    Using Child-Pugh score.

    Measured: 1 year

Timeline

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

  1. First posted8 Aug 2017
  2. Study start1 Dec 2017 (estimated)
  3. Primary completionJan 2019 (estimated)
  4. Study completionMar 2019 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03241823
Sponsor's protocol ID
AOHF
Status last verified
Aug 2017
First submitted
3 Aug 2017
Last updated
8 Aug 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Arase Y, Kobayashi M, Suzuki F, Suzuki Y, Kawamura Y, Akuta N, Kobayashi M, Sezaki H, Saito S, Hosaka T, Ikeda K, Kumada H, Kobayashi T. Effect of type 2 diabetes on risk for malignancies includes hepatocellular carcinoma in chronic hepatitis C. Hepatology. 2013 Mar;57(3):964-73. doi: 10.1002/hep.26087. Epub 2013 Feb 7.

    PubMed 22991257
  • Bruno S, Di Marco V, Iavarone M, Roffi L, Crosignani A, Calvaruso V, Aghemo A, Cabibbo G, Vigano M, Boccaccio V, Craxi A, Colombo M, Maisonneuve P. Survival of patients with HCV cirrhosis and sustained virologic response is similar to the general population. J Hepatol. 2016 Jun;64(6):1217-23. doi: 10.1016/j.jhep.2016.01.034. Epub 2016 Apr 5.

    PubMed 27059129
  • Charlton M, Everson GT, Flamm SL, Kumar P, Landis C, Brown RS Jr, Fried MW, Terrault NA, O'Leary JG, Vargas HE, Kuo A, Schiff E, Sulkowski MS, Gilroy R, Watt KD, Brown K, Kwo P, Pungpapong S, Korenblat KM, Muir AJ, Teperman L, Fontana RJ, Denning J, Arterburn S, Dvory-Sobol H, Brandt-Sarif T, Pang PS, McHutchison JG, Reddy KR, Afdhal N; SOLAR-1 Investigators. Ledipasvir and Sofosbuvir Plus Ribavirin for Treatment of HCV Infection in Patients With Advanced Liver Disease. Gastroenterology. 2015 Sep;149(3):649-59. doi: 10.1053/j.gastro.2015.05.010. Epub 2015 May 15.

    PubMed 25985734
  • Claudon M, Dietrich CF, Choi BI, Cosgrove DO, Kudo M, Nolsoe CP, Piscaglia F, Wilson SR, Barr RG, Chammas MC, Chaubal NG, Chen MH, Clevert DA, Correas JM, Ding H, Forsberg F, Fowlkes JB, Gibson RN, Goldberg BB, Lassau N, Leen EL, Mattrey RF, Moriyasu F, Solbiati L, Weskott HP, Xu HX; World Federation for Ultrasound in Medicine; European Federation of Societies for Ultrasound. Guidelines and good clinical practice recommendations for Contrast Enhanced Ultrasound (CEUS) in the liver - update 2012: A WFUMB-EFSUMB initiative in cooperation with representatives of AFSUMB, AIUM, ASUM, FLAUS and ICUS. Ultrasound Med Biol. 2013 Feb;39(2):187-210. doi: 10.1016/j.ultrasmedbio.2012.09.002. Epub 2012 Nov 5.

    PubMed 23137926
  • Enomoto M, Mori M, Ogawa T, Fujii H, Kobayashi S, Iwai S, Morikawa H, Tamori A, Sakaguchi H, Sawada A, Takeda S, Habu D, Shiomi S, Kawada N. Usefulness of transient elastography for assessment of liver fibrosis in chronic hepatitis B: Regression of liver stiffness during entecavir therapy. Hepatol Res. 2010 Sep;40(9):853-61. doi: 10.1111/j.1872-034X.2010.00687.x.

    PubMed 20887589

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C and Liver Cirrhosis, 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 6 inclusion and 3 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 8 Aug 2017. 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.

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 Sherif Kamel, MD (00201222303690, shereef_kamel@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in liver fibrosis (time frame: 1 year.). 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 NCT03241823, which also lists 5 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 8 Aug 2017.

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